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Agenus Reports Landmark BOT+BAL Data Showing 33% Three-Year Overall Survival in Refractory MSS Metastatic Colorectal Cancer Without Active Liver Metastases at ESMO GI 2026July 6, 2026 7:30 AM
Business Wire Fully enrolled 123-patient Phase 1b cohort demonstrated 21.2-month median overall survival, 33% three-year overall survival, and a survival curve plateau beyond two years Data presented in a heavily pretreated population where durable long-term survival is rarely reported 17% of patients alive and off all systemic anticancer therapy at last follow-up Extended safety follow-up showed no new safety signals, no treatment-related deaths, and 98% resolution of immune-mediated diarrhea/colitis Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced three-year landmark Phase 1b data from the fully enrolled C-800-01 cohort evaluating botensilimab (BOT), an Fc-enhanced multifunctional anti–CTLA-4 antibody, plus balstilimab (BAL), an anti–PD-1 antibody, in patients with refractory microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases. The data were presented at the European Society for Medical Oncology Gastrointestinal Cancers (ESMO GI) Congress 2026 on July 2 in Munich, Germany. BOT+BAL demonstrated clinically meaningful long-term survival in a heavily pretreated patient population with historically limited benefit from conventional immune checkpoint inhibitors and few durable treatment options after progression on standard therapies. With extended follow-up, median overall survival was 21.2 months and the three-year overall survival rate was 33%, with the Kaplan-Meier curve showing a plateau beyond two years. Available later-line standards in refractory MSS mCRC without active liver metastases have historically reported median overall survival of approximately 10–14 months in relevant analyses, reflecting a treatment setting in which few patients have historically remained alive at later landmark timepoints and pivotal studies have generally focused on median survival rather than mature 36-month overall survival outcomes.i In this context, the survival profile, curve plateau beyond two years, and proportion of patients alive and off systemic anticancer therapy support the durability of benefit observed with BOT+BAL in this fully enrolled 123-patient Phase 1b cohort. The data build on the two-year overall survival results presented by Dr. Benjamin L. Schlechter of Dana-Farber Cancer Institute at ESMO GI 2025 and reflect an additional year of follow-up from the same cohort. With longer follow-up, the dataset now includes 26 confirmed responses; median duration of response was not reached; and 21 patients, or 17%, were alive and off all systemic anticancer therapy at last follow-up, including 13 responders. “These three-year data are important because they show a pattern of benefit that is not typically expected in refractory MSS colorectal cancer,” said Benjamin L. Schlechter, M.D., of Dana-Farber Cancer Institute and presenting author of the study. “These are patients who had received multiple prior lines of therapy and had few remaining options. Seeing a subset of patients remain alive and off systemic anticancer therapy after treatment speaks to the clinical relevance of these results and the potential for botensilimab plus balstilimab to change expectations for what immunotherapy may achieve in this setting.” “BOT+BAL is not simply another checkpoint combination; it was designed to activate antitumor immunity in tumors that have been difficult to reach with conventional immunotherapy,” said Steven O’Day, M.D., Chief Medical Officer of Agenus. “With longer follow-up, we are seeing the elements that matter for a potentially differentiated immunotherapy regimen: durable survival, sustained responses, treatment-free intervals, and a manageable safety profile. These findings strengthen the foundation for BATTMAN and our broader development strategy in MSS colorectal cancer.” The Phase 1b (NCT03860272) cohort included 123 patients with MSS mCRC without active liver metastases. Patients had received a median of three prior lines of therapy; 67% had received at least three prior lines, 15% had received prior anti–PD-(L)1 with or without anti–CTLA-4 therapy, and 30% had received at least one later-line regimen of regorafenib, trifluridine/tipiracil with or without bevacizumab, or fruquintinib. Key Efficacy Results: Median overall survival: 21.2 months, with 24-month and 36-month overall survival rates of 41% and 33%, respectively Confirmed objective response rate: 21%, including three complete responses and 23 partial responses Median duration of response: not reached; responses ranged from 1.9 months to at least 37.4 months Disease control rate: 69% at six weeks Clinical benefit rate: 28% at 24 weeks Tumor regression: observed in more than 40% of patients Treatment-free survival: 21 patients or 17%, were alive and off all systemic anticancer therapy, including 13 responders with a subset of patients remaining free from subsequent therapy or death for more than two years In a post hoc late-line–exposed subgroup of 37 patients who had received at least one prior regimen of regorafenib, trifluridine/tipiracil with or without bevacizumab, or fruquintinib, BOT+BAL showed a confirmed objective response rate of 22%, median overall survival of 16.2 months, and a three-year overall survival rate of 30%. In this subgroup, median duration of response was 16.6 months, disease control rate was 70%, and clinical benefit rate at 24 weeks was 27%. Safety Results With extended follow-up, no new safety signals were observed and there were no treatment-related deaths. Immune-mediated diarrhea/colitis resolved in 98% of affected patients, with a median time to resolution of 14 days from onset. Treatment-related immune-mediated diarrhea/colitis was the most common immune-mediated adverse event (42%; grade ≥3, 15%). The selected Phase 3 regimen of BOT 1 mg/kg plus BAL demonstrated improved tolerability, with lower rates of immune-mediated diarrhea/colitis (27%; grade ≥3, 10%) than the 2 mg/kg regimen. Together, the mature efficacy, treatment-free survival, and extended safety findings support continued evaluation of BOT+BAL in MSS mCRC and provide rationale for the ongoing randomized Phase 3 BATTMAN trial evaluating BOT+BAL in refractory MSS/proficient mismatch repair (pMMR) metastatic colorectal cancer. Presentation Details Abstract Title: Botensilimab + Balstilimab in Microsatellite-Stable Metastatic Colorectal Cancer Without Active Liver Metastases: Extended Follow-Up and 3-Year Survival
Presenter: Benjamin L. Schlechter, M.D.; Dana-Farber Cancer Institute, Boston, MA, USA
Final Publication Number: 91P
Congress: European Society for Medical Oncology Gastrointestinal Cancers Congress 2026
Location: ESMO GI, 2026 | Munich, Germany
Poster Availability: The poster is available on the Agenus publications page. About the C-800-01 Study (NCT03860272) C-800-01 is a first-in-human Phase 1b clinical trial evaluating botensilimab with or without balstilimab in patients with advanced solid tumors. The MSS mCRC without active liver metastases cohort enrolled 123 patients who received BOT 1 mg/kg or 2 mg/kg every six weeks plus BAL 3 mg/kg every two weeks. The primary endpoint was safety and tolerability. Secondary endpoints included objective response rate, duration of response, disease control rate, and progression-free survival. Exploratory endpoints included overall survival and clinical benefit rate. About Agenus Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. About Botensilimab (BOT) Botensilimab (BOT) is a human Fc enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 1,300 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov. About Balstilimab (BAL) Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2025, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. References i Available later-line standards include regorafenib, trifluridine/tipiracil with or without bevacizumab, and fruquintinib in refractory metastatic colorectal cancer, including analyses in patients without active liver metastases (Ref 1-3). 1. Garcia-Carbonero R, et al. Presented at ESMO 2024. Poster #520P; 2. Tabernero J, et al. Presented at ASCO 2024. Poster #3584; 3. Cohen R, et al. Eur J Cancer. 2024;207:114160. View source version on businesswire.com: https://www.businesswire.com/news/home/20260706344475/en/ Investors
917-362-1370 | investor @Footprints-4422 | communications@agenusbio.com Original: Agenus Reports Landmark BOT+BAL Data Showing 33% Three-Year Overall Survival in Refractory MSS Metastatic Colorectal Cancer Without Active Liver Metastases at ESMO GI 2026
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2月前
Agenus and Noetik Present ASCO 2026 Data Linking AI Analysis of Routine Pretreatment Tumor Pathology Images to Response and Survival with BOT+BAL in MSS Metastatic CRCMay 21, 2026 5:00 PM
Business Wire Noetik’s TARIO-2 platform analyzed routine pretreatment H&E images from 113 BOT+BAL-treated patients and identified spatial tumor microenvironment patterns associated with response and survival In a retrospective analysis of refractory MSS metastatic colorectal cancer without active liver metastases, the AI-identified subgroup had a 64% response rate to BOT+BAL, compared with 9% in the remaining cohort Overall survival was significantly improved in the AI-identified MSS mCRC subgroup, with median overall survival not reached and a hazard ratio of 0.18 versus the remaining cohort Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced new retrospective data showing that Noetik’s artificial intelligence-based TARIO-2 model identified spatial tumor microenvironment patterns associated with clinical outcomes from routine pretreatment tumor pathology images in patients treated with botensilimab (BOT) plus balstilimab (BAL), Agenus’ investigational next-generation multifunctional, Fc-enhanced anti-CTLA-4 and anti-PD-1 immunotherapy combination. The data will be presented on May 30, 2026, by Ryan Dalton, Ph.D., of Noetik, during a poster session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation, titled “Artificial intelligence foundation model as a predictor of efficacy of next-generation checkpoint inhibition with botensilimab (BOT) + balstilimab (BAL) in solid tumors using pretreatment H&E images,” evaluated whether Noetik’s TARIO-2 model could analyze standard hematoxylin and eosin (H&E) pathology images to identify spatial tumor microenvironment patterns associated with clinical outcomes following treatment with BOT+BAL. BOT is an Fc-enhanced anti-CTLA-4 antibody designed to broaden anti-tumor immune activity through effects on T-cell priming, antigen presentation and regulatory T cells within the tumor microenvironment. Given BOT+BAL’s differentiated mechanism and prior observations that clinical activity is not strongly associated with traditional biomarkers such as PD-L1 expression or tumor mutational burden, broader tumor microenvironment-based approaches may be important for identifying patients most likely to benefit. The analysis included 113 efficacy-evaluable patients treated with BOT+BAL in the C-800-01 Phase 1b trial who had available pretreatment H&E images. Tumor cohorts included microsatellite stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases, ovarian cancer and sarcomas. The analysis evaluated TARIO-2’s ability to predict clinical endpoints including best overall response and overall survival. In the MSS mCRC without active liver metastases cohort, TARIO-2 demonstrated statistically significant predictive performance for both best overall response and overall survival. Supportive trends were observed in the ovarian cancer and sarcoma cohorts. In the MSS mCRC without active liver metastases cohort, TARIO-2 also outperformed benchmark pathology foundation models in predicting best overall response and overall survival. TARIO-2 does not rely on a traditional single-marker biomarker approach. Instead, the model applies AI-based spatial tumor microenvironment analysis to standard H&E pathology images, which are routinely generated during cancer diagnosis and clinical evaluation. By using widely available H&E images, TARIO-2 is designed to extract biologically relevant tumor microenvironment features without requiring more complex tissue-profiling approaches that may be difficult to implement routinely. This approach may support future patient stratification strategies if prospectively validated. “Routine pathology images are already part of cancer care, but much of the biologic information they contain is difficult to interpret by eye alone,” said Ryan Dalton, Ph.D., Senior Computational Scientist at Noetik. “These data suggest that AI-based analysis of pretreatment H&E images may help identify spatial tumor microenvironment patterns associated with clinical benefit from BOT+BAL. The findings support prospective validation of TARIO-2 as a practical, image-based biomarker strategy.” BOT+BAL is being evaluated as a novel immunotherapy combination designed to expand immune activity in tumors that have historically been difficult to treat with conventional immunotherapies. The ability to better understand which patients are most likely to benefit remains an important area of translational research, particularly in tumor types with limited immunotherapy options. “BOT+BAL is designed to engage the immune system in tumors that have historically been resistant to conventional immunotherapy, through differentiated mechanisms not fully captured by traditional biomarkers such as PD-L1 expression or tumor mutational burden,” said Dhan Chand, Ph.D., Vice President of Research at Agenus. “These data represent an important step toward aligning BOT+BAL’s differentiated biology with the patients most likely to benefit. Prospective validation will be an important next step as we continue to advance BOT+BAL clinical development.” The findings support prospective validation of TARIO-2 as an H&E-based biomarker strategy for BOT+BAL, including further evaluation in MSS colorectal cancer and broader solid tumor datasets. Following the poster session on May 30, 2026, the full poster will be available on the Publications page of the Agenus website. Presentation Details Abstract Title: Artificial intelligence (AI) foundation model as a predictor of efficacy of next-generation checkpoint inhibition with botensilimab (BOT) + balstilimab (BAL) in solid tumors using pretreatment H&E images
Abstract No.: 2535
Presenter: Ryan Dalton Ph.D., Sr. Computational Scientist, Noetik
Session Title: Poster Session – Developmental Therapeutics—Immunotherapy
Location: Hall A – Posters and Exhibits
Poster Board: 325
Date/Time: May 30, 2026, 1:30 PM–4:30 PM CDT About Agenus Agenus is a clinical-stage immuno-oncology company advancing a pipeline of antibody-based programs designed to activate innate and adaptive immunity, overcome tumor immune evasion, and expand the population of patients who may benefit from immunotherapy. Founded in 1994, Agenus’ lead program is botensilimab plus balstilimab (BOT+BAL), a next-generation Fc-enhanced CTLA-4 plus PD-1 combination. BOT alone or in combination with BAL has been evaluated in approximately 1,300 patients across more than nine tumor types. The global Phase 3 BATTMAN trial, conducted with the Canadian Cancer Trials Group, is evaluating BOT+BAL in refractory MSS/pMMR metastatic colorectal cancer. BOT/BAL is also available to eligible patients through regulatory-authorized access pathways in select countries, including France's national Autorisation d'Accès Compassionnel framework. Agenus also holds an equity investment in MiNK Therapeutics, Inc. (Nasdaq: INKT), a clinical-stage developer of allogeneic invariant natural killer T cell therapies, and a majority interest in SaponiQx, Inc., a vaccine adjuvant business. Agenus is headquartered in Lexington, Massachusetts. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on the Company's website and social media channels. About Botensilimab (BOT) Botensilimab (BOT) is a human Fc enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 1,300 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov. About Balstilimab (BAL) Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2025, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. View source version on businesswire.com: https://www.businesswire.com/news/home/20260521604737/en/ Agenus Investors: 917-362-1370 | investor @Footprints-4422 | communications@agenusbio.com Original: Agenus and Noetik Present ASCO 2026 Data Linking AI Analysis of Routine Pretreatment Tumor Pathology Images to Response and Survival with BOT+BAL in MSS Metastatic CRC
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2月前
Agenus Announces Publication of Phase 1b Botensilimab and Balstilimab Data in Post-Immunotherapy Hepatocellular Carcinoma in Liver CancerMay 15, 2026 4:11 PM
Business Wire Published prospective cohort showed durable responses and manageable safety in patients with HCC following prior immunotherapy Median overall survival of 12.3 months in a heavily pretreated population with poor prognostic features, including ALBI grade 2 liver function Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced the publication of Phase 1b data evaluating botensilimab (BOT), an Fc-enhanced anti-CTLA-4 antibody, in combination with balstilimab (BAL), an anti-PD-1 antibody, in patients with treatment-refractory hepatocellular carcinoma (HCC) who had progressed following prior immunotherapy. The manuscript, titled “A phase 1b study of botensilimab and balstilimab in treatment-refractory hepatocellular carcinoma,” was published in Liver Cancer and is available at DOI: 10.1159/000551630. The publication reports results from an expansion cohort of the Phase 1b C-800-01 study in 19 patients with HCC who had progressed on or after prior immunotherapy. The cohort represents a difficult-to-treat population for which prospective data remain limited, including 47% of patients with albumin-bilirubin (ALBI) grade 2 liver function, a marker of poorer liver reserve and prognosis in HCC. In published HCC studies, ALBI grade 2 liver function has been linked to a 4- to 10-month decrement in median overall survival compared with ALBI grade 1, underscoring the poor prognosis and reduced responsiveness typically observed in this population.i Among 18 efficacy-evaluable patients, BOT+BAL demonstrated an objective response rate (ORR) of 17%, including one complete response and two partial responses. The 18-week clinical benefit rate (CBR) was 50%. Median duration of response (mDOR) was not reached, median progression-free survival (mPFS) was 4.4 months, and median overall survival (mOS) was 12.3 months. All patients had received prior anti-PD-(L)1 therapy, 68% had received prior tyrosine kinase inhibitors, and 58% had received prior atezolizumab/bevacizumab. One patient experienced stable disease for 66 weeks, supporting the conclusion that benefit with BOT+BAL was not confined to RECIST response alone. Treatment options after immune checkpoint inhibitor (ICI) therapy in advanced HCC remain limited, and available systemic therapies have generally shown modest activity. Published studies evaluating lenvatinib, cabozantinib and regorafenib after ICI-based therapy have reported objective response rates of 6–14%, median progression-free survival of approximately 4–5 months and median overall survival of ≤10.5 months.ii The BOT+BAL results therefore, provide early prospective evidence of activity in a post-ICI HCC population that included patients with adverse prognostic features often underrepresented in later-line studies. “This publication adds to a consistent body of clinical evidence showing BOT plus BAL activity across difficult-to-treat, late-line solid tumors,” said Steven O’Day, MD, Chief Medical Officer of Agenus. “In HCC, where tumor biology and underlying liver function both shape treatment outcomes, these data further support the rationale for botensilimab’s Fc-enhanced CTLA-4 design and its potential to drive immune activity in settings where conventional checkpoint approaches have had limited impact.” “Patients with advanced HCC who progress after immunotherapy have limited treatment options, and outcomes can be especially poor when liver function is compromised,” said Anthony B. El-Khoueiry, MD, Chief of Section of Developmental Therapeutics and Associate Director for Clinical Research at USC Norris Comprehensive Cancer Center, part of Keck Medicine of USC, and principal investigator of the study. “In this exploratory cohort, seeing objective responses, prolonged disease control and a median overall survival of 12.3 months is encouraging and supports continued study of BOT plus BAL in this post-immunotherapy setting.” The safety profile of BOT+BAL in the HCC cohort was consistent with prior reports across the broader Phase 1b program. There were no treatment-related deaths and no new class safety signals. Immune-mediated treatment-related adverse events occurred in 68% of patients, with grade 3 events in 37%. The most common immune-mediated treatment-related adverse events were diarrhea/colitis, hepatitis and dermatologic events. No grade 4 or higher immune-mediated treatment-related adverse events were reported. All immune-mediated hepatitis events resolved to grade 1 or lower. HCC is the most common form of liver cancer and is often diagnosed at an advanced stage. Immune checkpoint inhibitor combinations have improved outcomes in the frontline setting, but patients who progress after immunotherapy have limited prospective evidence to guide subsequent treatment. In the published manuscript, the authors concluded that BOT+BAL demonstrated promising efficacy and manageable safety in previously treated HCC, including patients who progressed after frontline immunotherapy, and that these findings warrant further investigation. About the C-800-01 Study C-800-01 (NCT03860272) is an open-label, multicenter Phase 1b clinical trial evaluating botensilimab in combination with or without balstilimab in patients with advanced solid tumors. The trial enrolled over 400 patients with refractory disease and included tumor types with limited or no responsiveness to prior checkpoint inhibitors. The HCC expansion cohort enrolled 19 patients between March 2021 and September 2023 across six U.S. sites. Patients received botensilimab at 1 mg/kg or 2 mg/kg once every six weeks plus balstilimab 3 mg/kg once every two weeks. The safety analysis included all 19 patients who received at least one dose of study drug, and the efficacy-evaluable analysis included 18 patients with at least one post-baseline imaging scan. About Agenus Agenus is a clinical-stage immuno-oncology company advancing a pipeline of antibody-based programs designed to activate innate and adaptive immunity, overcome tumor immune evasion, and expand the population of patients who may benefit from immunotherapy. Founded in 1994, Agenus’ lead program is botensilimab plus balstilimab (BOT+BAL), a next-generation Fc-enhanced CTLA-4 plus PD-1 combination. BOT alone or in combination with BAL has been evaluated in approximately 1,300 patients across more than nine tumor types. The global Phase 3 BATTMAN trial, conducted with the Canadian Cancer Trials Group, is evaluating BOT+BAL in refractory MSS/pMMR metastatic colorectal cancer. BOT/BAL is also available to eligible patients through regulatory-authorized access pathways in select countries, including France's national Autorisation d'Accès Compassionnel framework. Agenus also holds an equity investment in MiNK Therapeutics, Inc. (Nasdaq: INKT), a clinical-stage developer of allogeneic invariant natural killer T cell therapies, and a majority interest in SaponiQx, Inc., a vaccine adjuvant business. Agenus is headquartered in Lexington, Massachusetts. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on the Company's website and social media channels. About Botensilimab (BOT) Botensilimab (BOT) is a human Fc enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 1,300 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov. About Balstilimab (BAL) Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2025, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. References _____________________________ i Feng D, Wang M, Hu J, Li S, Zhao S, Li H, et al. Prognostic value of the albumin-bilirubin grade in patients with hepatocellular carcinoma and other liver diseases. Ann Transl Med. 2020;8(8):553; Chan SL, Ryoo BY, Mo F, Chan LL, Cheon J, Li L, et al. Multicentre phase II trial of cabozantinib in patients with hepatocellular carcinoma after immune checkpoint inhibitor treatment. J Hepatol. 2024;81(2):258-264. ii Chan SL, Ryoo BY, Mo F, Chan LL, Cheon J, Li L, et al. Multicentre phase II trial of cabozantinib in patients with hepatocellular carcinoma after immune checkpoint inhibitor treatment. J Hepatol. 2024;81(2):258-264; Cheon J, Ryoo BY, Chon HJ, Kim HD, Ryu MH, Kim KP, et al. Multicenter Phase 2 Trial of Second-Line Regorafenib in Patients with Unresectable Hepatocellular Carcinoma after Progression on Atezolizumab plus Bevacizumab. Liver Cancer. 2025;14(4):446-455; Kim HD, Sym SJ, Chon HJ, Kim M, Kang JH, Ryoo BY, et al. Multicenter single-arm phase II trial of lenvatinib in patients with advanced hepatocellular carcinoma after progression on first-line atezolizumab plus bevacizumab. J Hepatol. 2026;84(2):308-315. View source version on businesswire.com: https://www.businesswire.com/news/home/20260515976818/en/ Agenus Investors: 917-362-1370 | investor @Footprints-4422 | communications@agenusbio.com Original: Agenus Announces Publication of Phase 1b Botensilimab and Balstilimab Data in Post-Immunotherapy Hepatocellular Carcinoma in Liver Cancer
US Market News
2月前
Agenus Reports First Quarter 2026 Financial Results and Highlights BOT+BAL Execution Across Global Access and Phase 3 DevelopmentMay 11, 2026 8:45 AM
Business Wire Authorized access interest continues to expand across regions Phase 3 BATTMAN trial commenced patient enrollment in April 2026, advancing BOT+BAL into pivotal evaluation Zydus collaboration closed in January, delivering strategic capital, strengthening Agenus’ balance sheet and securing dedicated U.S. biologics manufacturing capacity Agenus continues to align operating priorities around BOT+BAL, financial discipline and commercial readiness SEC concluded its investigation in May 2026 with no enforcement action recommended; Related putative securities class action dismissed in its entirety by the U.S. District Court for the District of Massachusetts in March 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today reported financial results for the first quarter ended March 31, 2026, and provided an operational update on botensilimab plus balstilimab (BOT+BAL), the Company’s lead clinical program and one of the most clinically advanced next-generation CTLA-4/PD-1 combinations in development. The first quarter marked a transition from foundation-building to execution for BOT+BAL. Physician engagement through regulatory-authorized access pathways continued to broaden, the Phase 3 BATTMAN trial moved into active enrollment shortly after quarter-end, and the Zydus collaboration closed, delivering strategic capital and dedicated U.S. manufacturing capacity. BOT+BAL is designed to activate both innate and adaptive immunity and extend immunotherapy benefit into tumors that have historically shown limited responsiveness to checkpoint inhibition. “First quarter 2026 was a defining quarter for Agenus and for BOT and BAL," said Garo H. Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. "We saw continued physician requests and engagement treating patients with BOT and BAL through regulatory-authorized access pathways. Additionally, we advanced the program into Phase 3 enrollment and closed a transformative collaboration with Zydus that secured both capital and U.S. manufacturing capacity. BOT+BAL’s maturing data, particularly the durability of survival outcomes in refractory MSS colorectal cancer, continue to underpin our regulatory submissions in the United States and Europe." Key Operational Highlights Agenus is concentrating resources on BOT+BAL across three priorities: supporting physician-initiated access through regulatory-authorized pathways where permitted, advancing the Phase 3 BATTMAN trial, and building the clinical, manufacturing and operational readiness needed for the next stage of development. Continued Physician Engagement Through Regulatory-Authorized Access Pathways In parallel with clinical development, Agenus continues to support BOT+BAL access through regulatory-authorized pathways in certain countries. These programs are physician-initiated, patient-specific and governed by local regulations. In France, BOT+BAL is available under the national Autorisation d’Accès Compassionnel framework for eligible patients, with reimbursed access across MSS metastatic colorectal cancer without active liver metastases, platinum-resistant or platinum-refractory ovarian cancer, and certain advanced soft-tissue sarcomas. Outside France, BOT+BAL may be available in select countries through paid named-patient programs, which may involve out-of-pocket payment and/or special insurance arrangements depending on local requirements and individual coverage decisions. In Q1 2026, paid named-patient activity broadened to additional countries in South and Central America and Europe, reflecting continued physician interest and the unmet need for new options while regulatory review pathways advance. In April 2026, Agenus named BAP Pharma as its global partner to support BOT+BAL access programs, including France’s AAC pathway and paid named-patient programs. BAP Pharma will support program requests, case coordination, regulatory navigation, distribution logistics and related payment processing, helping Agenus build a more consistent and scalable access infrastructure. Medical Affairs Infrastructure Expanded to Support Increasing Physician Requests Agenus also expanded Medical Affairs and early-access support capabilities to respond to increasing physician-initiated interest. These capabilities support scientific exchange, access request coordination, pharmacovigilance and structured collection of real-world safety and outcomes data where applicable. Phase 3 BATTMAN Trial Active and Enrolling The global Phase 3 BATTMAN trial commenced patient enrollment in April 2026 and is evaluating BOT+BAL versus best supportive care in patients with refractory, unresectable MSS/pMMR metastatic colorectal cancer, a setting where checkpoint inhibitors have historically shown limited benefit and treatment options remain limited. BATTMAN is led by the Canadian Cancer Trials Group as an international cooperative-group trial, with participating academic networks in Canada, France, Australia and New Zealand. Site activation continues across participating regions. With BATTMAN underway, BOT+BAL is among the most clinically advanced next-generation CTLA-4/PD-1 immunotherapy programs in refractory colorectal cancer, supported by a global randomized Phase 3 study. Zydus Collaboration Closed Strengthening Capital Position, Balance Sheet and Manufacturing Readiness In January 2026, Agenus closed its previously announced strategic collaboration with Zydus Lifesciences, providing upfront capital and dedicated biologics manufacturing capacity to support clinical development, authorized access programs and potential future commercial supply of BOT+BAL. At closing, Zydus paid $91 million of upfront capital, subject to customary adjustments and escrow arrangements, and the $7.0 million Zydus Promissory Note was forgiven. The collaboration delivered: $75 million in cash consideration for the transfer of the Emeryville and Berkeley biologics manufacturing facilities $16 million equity investment in Agenus common stock Up to $50 million in contingent payments from Zydus tied to BOT and BAL production orders by Agenus An exclusive license for Zydus to develop and commercialize BOT and BAL in India and Sri Lanka, with Agenus eligible to receive royalties on net sales in those territories The collaboration strengthens Agenus’ balance sheet while securing dedicated U.S. manufacturing infrastructure for the next stage of BOT+BAL clinical, regulatory and commercial expansion. It also supports Agenus’ ability to supplement existing supply for clinical development, authorized access pathways and potential future commercial readiness without requiring additional Agenus capital expenditures for dedicated manufacturing infrastructure. Clinical Data Continue to Support Immune Activation and Durability Across Hard-to-Treat Tumors Recent clinical and translational data presentations continue to add to the broader BOT+BAL evidence base, including evaluations of BOT+BAL in combination approaches across additional difficult-to-treat tumor types and in earlier stages of MSS mCRC treatment. These datasets support the Company’s view that BOT+BAL may contribute to durable, immune-mediated activity across tumors that have historically responded poorly to checkpoint inhibition. Across Phase 1 and Phase 2 clinical trials, approximately 1,300 patients have been treated with botensilimab and/or balstilimab, with clinical activity observed across more than nine metastatic, late-line cancers settings. Agenus continues to view durability, survival and immune activation, rather than response rates alone, as meaningful measures of BOT+BAL’s clinical potential in cold or treatment-refractory tumors historically resistant to checkpoint inhibition. First Quarter 2026 Financial Results Cash and cash equivalents totaled $35.0 million as of March 31, 2026, compared with $3.0 million as of December 31, 2025. Subsequent to quarter-end, the Company received an additional $11.7 million in net proceeds from sales of common stock under its at-the-market equity offering program. The Company also expects to collect outstanding receivables under regulatory-authorized early access programs during the second quarter of 2026. Pre-commercial product revenue of $4.6 million represents realized income from BOT+BAL provided to hospitals and treating physicians under regulatory-authorized early access pathways, including France's AAC framework and paid named-patient programs in countries where permitted. During the first quarter of 2026, Agenus made cash payments of approximately $51.8 million, principally to fund (i) the release of commercial-grade botensilimab supply through contract development and manufacturing organizations; (ii) the generation of clinical data sets through contract research organizations and clinical support providers in support of the Company's planned accelerated approval submission in the United States and conditional marketing authorization application in the European Union; and (iii) settlement of obligations in connection with the closing of the Zydus collaboration, including finance lease and debt obligations, and other closing-related payments. These payments partly settled liabilities accrued in prior periods. Agenus’ first quarter cash payments included substantial obligations associated with the Zydus closing and the build-out of clinical and pre-commercial supply. These are not representative of Agenus’ recurring operating expense profile. The Company continues to align its operating expense base with its previously communicated framework of approximately $50 million in annualized operating expenses to support BOT+BAL development priorities, and first quarter 2026 underlying operating performance was consistent with that framework. In March 2026, Agenus triggered the first $20.0 million contingent payment from Zydus under the collaboration based on Zydus services provided which includes contracted work orders for BOT+BAL production activities. All contingent payments by Zydus are to fund services to be provided by Zydus to the Company. Metric Q1 2026 Q1 2025 Pre-commercial product revenue $4.6 million $0 million Non-cash royalty revenue $29.1 million $23.6 million Service and other revenue $0 million $0.5 million Total revenue $33.7 million $24.1 million Operating income (loss) $15.1 million $(13.3) million Net income (loss) $39.2 million $(26.4) million Cash, cash equivalents and short-term investments $35.0 million $18.5 million 2026 Strategic Priorities Support responsible authorized access through France’s AAC framework and paid named-patient programs in select countries, with BAP Pharma serving as global access partner Continue regulatory engagement, including planned accelerated approval and conditional marketing authorization pathways, supported by clinical data and real-world experience generated through authorized access pathways where applicable Advance global BATTMAN trial enrollment in partnership with CCTG and participating academic networks Maintain disciplined capital allocation and continue strengthening the balance sheet Continue clinical and translational data generation across BOT+BAL programs Resolution of SEC Investigation and Dismissal of Securities Class Action On May 4, 2026, the U.S. Securities and Exchange Commission informed Agenus that it has concluded its investigation as to the Company and does not intend to recommend an enforcement action. Separately, on March 24, 2026, the U.S. District Court for the District of Massachusetts granted Agenus's motion to dismiss the related putative securities class action in its entirety. The lead plaintiff has filed a Notice of Appeal to the U.S. Court of Appeals for the First Circuit. Additional information regarding both matters is included in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2026. Webcast and Annual Shareholder Meeting Information Agenus will host a webcast in connection with its Annual Shareholder Meeting in June 2026 to provide strategic updates, highlight key data milestones and discuss progress across the global BOT+BAL development program. Additional details, including webcast access information, will be announced prior to the event. About Agenus Agenus is a clinical-stage immuno-oncology company advancing a pipeline of antibody-based programs designed to activate innate and adaptive immunity, overcome tumor immune evasion, and expand the population of patients who may benefit from immunotherapy. Founded in 1994, Agenus’ lead program is botensilimab plus balstilimab (BOT+BAL), a next-generation Fc-enhanced CTLA-4 plus PD-1 combination that has been evaluated in approximately 1,300 patients across more than nine tumor types. The global Phase 3 BATTMAN trial, conducted with the Canadian Cancer Trials Group, is evaluating BOT+BAL in refractory MSS/pMMR metastatic colorectal cancer. BOT/BAL is also available to eligible patients through regulatory-authorized access pathways in select countries, including France's national Autorisation d'Accès Compassionnel framework. Agenus secured dedicated long-term U.S. biologics manufacturing capacity through its strategic collaboration with Zydus Lifesciences, closed in January 2026. Agenus also holds an equity investment in MiNK Therapeutics, Inc. (Nasdaq: INKT), a clinical-stage developer of allogeneic invariant natural killer T cell therapies, and a majority interest in SaponiQx, Inc., a vaccine adjuvant business. Agenus is headquartered in Lexington, Massachusetts. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on the Company's website and social media channels. About BATTMAN CO.33 Phase 3 Trial The BATTMAN (CCTG CO.33) trial is a global Phase 3, randomized, controlled study evaluating botensilimab (BOT) plus balstilimab (BAL) versus best supportive care in patients with refractory, unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) colorectal cancer. Conducted as an international cooperative-group study led by the Canadian Cancer Trials Group (CCTG), the trial is expected to enroll approximately 830 patients across more than 100 sites in Canada, France, Australia, and New Zealand. Participating academic networks include CCTG, GI Cancer Trials, and France’s Partenariat de Recherche en Oncologie Digestive (PRODIGE), sponsored by Unicancer. This registrational-enabling study is designed to support potential regulatory submissions for BOT+BAL in this difficult-to-treat patient population. Agenus’ Commitment to Patient Access Until marketing authorization is granted, BOT+BAL is accessible only through clinical trials including the Phase 3 BATTMAN trial in refractory MSS colorectal cancer and authorized early access mechanisms where permitted and available under each country’s regulatory framework. For eligible French patients treated in hospital under AAC meeting the pre-defined criteria, BOT+BAL is fully reimbursed by France’s national health system. Outside France, access may be available in select countries through paid named-patient programs, which may involve out-of-pocket payment and/or special insurance arrangements depending on local regulations and individual coverage decisions. About Botensilimab (BOT) Botensilimab (BOT) is a human Fc-enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 1,300 patients have been treated with botensilimab and/or balstilimab in Phase 1 and Phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov. About Balstilimab (BAL) Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding Agenus’ botensilimab and balstilimab programs, access programs, clinical development plans, manufacturing readiness, operating expense reductions, financial outlook, and any other statements containing the words “may,” “believes,” “expects,” “anticipates,” “hopes,” “intends,” “plans,” “forecasts,” “estimates,” “will,” “potential,” and similar expressions intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of Agenus’ most recent Annual Report on Form 10-K for 2025 and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. View source version on businesswire.com: https://www.businesswire.com/news/home/20260511199340/en/ Investors: 917-362-1370 |
US Market News
2月前
Agenus to Provide First Quarter 2026 Financial Report and Corporate UpdateMay 4, 2026 4:30 PM
Business Wire Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in immuno-oncology, today announced that the Company will release its first quarter 2026 financial results before the market opens on Monday, May 11, 2026. Agenus plans to host a webcast in June, in conjunction with its Annual Meeting of Shareholders, to spotlight key strategic priorities, upcoming data milestones, and progress across the global botensilimab (BOT) and balstilimab (BAL) development program. About Agenus Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. About Botensilimab (BOT) Botensilimab (BOT) is a human Fc enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 1,200 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov. About Balstilimab (BAL) Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2024, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Source: Agenus Bio View source version on businesswire.com: https://www.businesswire.com/news/home/20260504196835/en/ Investors : 917-362-1370 |
US Market News
3月前
Agenus désigne BAP Pharma comme partenaire mondial exclusif pour les programmes d’accès à la combinaison BOT+BALApril 21, 2026 8:55 PM
Business Wire
Ce partenariat vise à permettre un accès rapide au botensilimab associé au balstilimab dans le cadre du dispositif français d’Autorisation d’accès compassionnel (AAC), pris en charge par l’État, ainsi que dans le cadre de programmes de prise en charge de patients désignés (« named-patient programs », NPP) financés dans certains pays
Agenus Inc. (Nasdaq : AGEN), une entreprise de premier plan dans le domaine de l’innovation en immuno-oncologie, et BAP Pharma, une société internationale spécialisée dans l’accès aux médicaments et l’approvisionnement pour les essais cliniques, ont annoncé aujourd’hui que BAP Pharma avait été désignée en exclusivité comme partenaire mondial d’Agenus pour les programmes autorisés d’accès mondial au botensilimab (BOT) associé au balstilimab (BAL).
Ce communiqué de presse contient des éléments multimédias. Voir le communiqué complet ici : https://www.businesswire.com/news/home/20260421192554/fr/
Ce partenariat vise à garantir un accès conforme et centré sur le patient au traitement BOT+BAL par le biais de voies d’accès autorisées, dans la mesure permise par les réglementations locales. À compter de ce jour, BAP Pharma devient le partenaire exclusif d’Agenus pour la coordination des opérations relatives aux programmes autorisés d’accès mondial à la combinaison BOT+BAL. BAP Pharma sera notamment chargée des demandes d’accès au programme, de la coordination des dossiers, de la logistique de distribution et du traitement des paiements afférents.
Ces programmes comprennent le dispositif français d’Autorisation d’accès compassionnel (AAC) ainsi que des programmes de prise en charge de patients désignés (« named-patient programs » ou NPP) financés dans certains pays hors les États-Unis. Comme indiqué précédemment, Agenus a reçu à ce jour plus de 270 demandes d’informations de la part de médecins issus de plus de 30 pays dans le cadre de ces dispositifs.
« Les médecins du monde entier continuent de manifester un vif intérêt pour la combinaison BOT+BAL dans le cadre des programmes autorisés d’accès anticipé, sur la base du corpus croissant de données cliniques recueillies à ce jour, mais aussi en raison du besoin urgent de disposer de meilleures options thérapeutiques pour les patients atteints de cancers graves », a déclaré Garo H. Armen, PhD, président-directeur général d’Agenus. « Notre partenariat exclusif avec BAP Pharma renforce l’infrastructure qui sous-tend ces programmes et consolide notre engagement à agir de manière responsable et efficace. Lorsque l’accès est autorisé, nous estimons qu’il est de notre devoir moral d’aider à offrir un accès approprié et conforme aux patients dont les médecins recherchent de nouvelles alternatives. »
Le programme AAC français permet aux patients éligibles atteints d’un cancer colorectal métastatique stable au niveau des microsatellites (MSS) sans métastases hépatiques actives, d’un cancer de l’ovaire résistant ou réfractaire au platine, ainsi que de certains sarcomes des tissus mous avancés, de bénéficier d’un accès au traitement BOT+BAL en milieu hospitalier, avec une prise en charge intégrale par l’État, dans le cadre d’un protocole défini au niveau national. Ces patients sont généralement atteints de cancers à un stade avancé pour lesquels les options thérapeutiques standard ont été épuisées. En dehors de la France, le traitement BOT+BAL peut être disponible dans certains pays dans le cadre de programmes de prise en charge de patients désignés (NPP), mis en place à l’initiative de médecins traitants et régis par la réglementation locale, notamment lorsqu’un médecin traitant estime que la combinaison BOT+BAL constitue une option appropriée pour un patient donné, sur la base des données cliniques disponibles à ce jour, des besoins médicaux et des exigences locales applicables.
L’intérêt des médecins pour l’accès au traitement BOT+BAL ne cesse de croître dans les différentes régions du monde. Des patients ont déjà été traités dans le cadre de programmes NPP financés et autorisés par les autorités réglementaires dans plusieurs pays d’Amérique du Sud, d’Amérique centrale et d’Europe, notamment au Royaume-Uni, en Suisse, en Grèce, au Brésil et en Argentine, et l’expansion se poursuit en Espagne, dans la mesure permise par la réglementation locale.
Dans le cadre de cette collaboration, BAP Pharma coordonnera les activités d’accès mondiales d’Agenus pour l’ensemble de ces programmes. BAP Pharma apporte à cette collaboration sa vaste expertise internationale en matière d’accès aux médicaments, son approche professionnelle et réactive permettant d’impliquer les médecins et les sites d’essais cliniques, ainsi que sa rigueur opérationnelle nécessaire pour rationaliser la logistique, renforcer la coordination régionale et aider les médecins traitants à se conformer aux cadres réglementaires propres à chaque pays.
« L’équipe de BAP Pharma a démontré qu’elle possédait le professionnalisme, la réactivité et la rigueur opérationnelle indispensables pour soutenir les programmes d’accès mondial », a déclaré le Dr Kamel Djazouli, responsable des affaires médicales chez Agenus. « Son approche correspond parfaitement à l’engagement que nous avons pris envers les médecins et les patients qui souhaitent accéder au traitement par les voies autorisées, et nous sommes convaincus que ce partenariat permettra d’améliorer l’expérience des équipes soignantes à travers le monde. »
Le Dr Bashir Parkar, fondateur de BAP Pharma, a confié pour sa part : « Le fait d’avoir été sélectionnés comme partenaire mondial exclusif d’Agenus représente une étape importante pour BAP Pharma. Cela témoigne de la confiance accordée à notre capacité à fournir, à grande échelle, des solutions d’accès conformes et centrées sur le patient. Notre rôle est de simplifier les procédures afin de garantir que les médecins puissent accéder rapidement et en toute confiance aux traitements essentiels pour leurs patients, dans le strict respect des réglementations. »
Rebecca Bibby, directrice du groupe « Accès aux médicaments » (Medicines Access) chez BAP Pharma, a ajouté : « Ce partenariat témoigne de l’importance croissante des programmes d’accès mondial bien structurés dans le contexte clinique et réglementaire actuel. En associant les traitements innovants d’Agenus à l’expertise opérationnelle mondiale de BAP Pharma, nous offrons aux médecins et aux patients un parcours plus fluide et plus fiable pour explorer diverses options d’accès précoce. »
Les initiatives d’accès précoce d’Agenus viennent compléter sa stratégie de développement clinique en cours pour la combinaison BOT+BAL, notamment l’essai mondial de phase III BATTMAN portant sur le cancer colorectal métastatique réfractaire, stable au niveau des microsatellites (MSS) et sans déficit du système de réparation des mésappariements (pMMR). Tant que l’autorisation de mise sur le marché n’aura pas été accordée, le traitement BOT+BAL ne sera disponible que dans le cadre d’essais cliniques ou de voies d’accès autorisées, lorsque celles-ci sont approuvées et disponibles en vertu de cadres réglementaires locaux. Pour plus d’informations sur l’accès des patients, prière de consulter la page web d’Agenus consacrée à la politique d’accès aux médicaments expérimentaux (« Access to Investigational Medicines Policy »).
À propos d’Agenus
Agenus est une entreprise de premier plan dans le domaine de l’immuno-oncologie qui développe un pipeline complet d’agents immunologiques pour lutter contre le cancer. Fondée en 1994, la société s’est donné pour mission d’élargir les populations de patients pouvant bénéficier d’une immunothérapie contre le cancer, en combinant différentes approches et en s’appuyant sur un large éventail de traitements à base d’anticorps, de thérapies cellulaires adoptives (via MiNK Therapeutics) et d’adjuvants. Agenus dispose de solides capacités de développement de bout en bout, couvrant des installations de fabrication commerciales et cliniques conformes aux bonnes pratiques de fabrication, ainsi que la recherche et la découverte. Elle bénéficie également d’une présence mondiale en matière d’opérations cliniques. Le siège d’Agenus est situé à Lexington, dans le Massachusetts. Pour en savoir plus, rendez-vous sur www.agenusbio.com ou suivez @agenus_bio. Les informations susceptibles d’être importantes pour les investisseurs seront régulièrement publiées sur notre site web et nos canaux de réseaux sociaux.
À propos du botensilimab (BOT)
Le botensilimab (BOT) est un anticorps anti-CTLA-4 multifonctionnel humain, doté d’un fragment Fc amélioré, conçu pour renforcer les réponses immunitaires antitumorales innées et adaptatives. Sa conception novatrice exploite des mécanismes d’action qui permettent d’étendre les avantages de l’immunothérapie aux tumeurs dites « froides » qui répondent généralement mal aux traitements standard ou qui sont réfractaires aux thérapies PD-1/CTLA-4 conventionnelles et aux thérapies expérimentales. Le botensilimab amplifie les réponses immunitaires dans un large éventail de types de tumeurs en amorçant et en activant les lymphocytes T, en régulant à la baisse les lymphocytes T régulateurs intratumoraux, en activant les cellules myéloïdes et en induisant des réponses mémorielles à long terme.
Environ 1?200 patients ont été traités par le botensilimab et/ou le balstilimab dans le cadre d’essais cliniques de phases 1 et 2. Le botensilimab, utilisé seul ou en association avec le balstilimab (un anticorps anti-PD-1 expérimental développé par Agenus), a permis d’obtenir des réponses cliniques dans neuf cancers métastatiques traités en phase avancée. Pour plus d’informations sur les essais cliniques portant sur le botensilimab, rendez-vous sur www.clinicaltrials.gov.
À propos du balstilimab (BAL)
Le balstilimab est une nouvelle immunoglobuline G4 (IgG4) monoclonale entièrement humaine conçue pour empêcher la PD-1 (protéine 1 de mort cellulaire programmée) d’interagir avec ses ligands PD-L1 et PD-L2. Elle a été évaluée chez plus de 900 patients à ce jour et a démontré une efficacité clinique ainsi qu’un profil de tolérance favorable dans plusieurs types de tumeurs.
À propos de BAP Pharma
BAP Pharma est un partenaire mondial de l’industrie pharmaceutique et de l’industrie biotechnologique qui propose des solutions d’approvisionnement pour les essais cliniques ainsi que des solutions d’accès aux médicaments. L’accès aux médicaments est au cœur de son activité : l’entreprise a pour objectif de permettre un accès rapide et conforme aux traitements essentiels grâce à des programmes d’accès précoce et contrôlé mis en place dans le monde entier. À travers l’ensemble de ses services, BAP Pharma vise à offrir une certitude, en éliminant les complexités et en renforçant la confiance des promoteurs, des médecins et des patients.
Site web : https://bappharma.com/
LinkedIn : https://linkedin.com/company/bap-pharma
Déclarations prospectives
Le présent communiqué de presse contient des déclarations prospectives formulées conformément aux dispositions d’exonération (« safe harbor ») prévues par les lois fédérales sur les valeurs mobilières, notamment des déclarations concernant ses programmes liés au botensilimab et au balstilimab, ainsi que les délais réglementaires et les dépôts prévus. Il peut également comporter d’autres déclarations prospectives reconnaissables à l’emploi de termes tels que « pouvoir », « croire », « prévoir », « anticiper », « espérer », « avoir l’intention de », « planifier », « projeter », « estimer », « établir », « potentiel », « supériorité », « meilleur de sa catégorie », l’emploi du futur et du conditionnel et d’autres expressions similaires permettant d’identifier les déclarations prospectives. Ces déclarations prospectives sont soumises à des risques et incertitudes susceptibles d’entraîner des résultats réels sensiblement différents. Ces risques et incertitudes incluent notamment les facteurs décrits dans la section « Facteurs de risque » de notre dernier rapport annuel sur formulaire 10-K pour l’exercice 2025, ainsi que dans les rapports trimestriels ultérieurs sur formulaire 10-Q déposés auprès de la Securities and Exchange Commission. Agenus met en garde les investisseurs contre le fait d’accorder une confiance excessive aux déclarations prospectives figurant dans le présent communiqué. Ces déclarations ne sont valables qu’à la date de publication du présent communiqué de presse, et Agenus ne s’engage en aucune façon à les mettre à jour ou à les réviser, sauf si la loi l’exige. Toutes les déclarations prospectives sont expressément visées par la présente mise en garde.
Source: Agenus Inc. & BAP Pharma
Le texte du communiqué issu d’une traduction ne doit d’aucune manière être considéré comme officiel. La seule version du communiqué qui fasse foi est celle du communiqué dans sa langue d’origine. La traduction devra toujours être confrontée au texte source, qui fera jurisprudence.
Consultez la version source sur businesswire.com : https://www.businesswire.com/news/home/20260421192554/fr/
Contact investisseurs Agenus : 917-362-1370 | investor@agenusbio.com
Contact médias Agenus : 781-674-4422 | communications@agenusbio.com
BAP Pharma Media : Jason De Kauwe | Jason.DeKauwe@bappharma.com
Original: Agenus désigne BAP Pharma comme partenaire mondial exclusif pour les programmes d’accès à la combinaison BOT+BAL
US Market News
3月前
Agenus ernennt BAP Pharma zum exklusiven globalen Partner für die BOT+BAL-ZugangsprogrammeApril 21, 2026 8:55 PM
Business Wire
Die Partnerschaft ermöglicht den zeitnahen Zugang zu Botensilimab plus Balstilimab über das von der französischen Regierung erstattete AAC-Verfahren (Autorisation d’Accès Compassionnel) und über kostenpflichtige Named-Patient-Programme (NPP) in ausgewählten Ländern
Agenus Inc. (Nasdaq: AGEN), ein führendes Unternehmen im Bereich der Immunonkologie, und BAP Pharma, ein weltweit tätiges Unternehmen im Bereich Arzneimittelzugang und die Versorgung klinischer Studien, gaben heute die Ernennung von BAP Pharma zum exklusiven globalen Partner von Agenus für die globalen, autorisierten Zugangsprogramme für Botensilimab (BOT) plus Balstilimab (BAL) bekannt.
Diese Pressemitteilung enthält multimediale Inhalte. Die vollständige Mitteilung hier ansehen: https://www.businesswire.com/news/home/20260421799131/de/
Die Partnerschaft unterstützt den regelkonformen, patientenorientierten Zugang zu BOT+BAL über autorisierte Zugangswege, wo diese nach geltenden Vorschriften zulässig sind. Ab sofort übernimmt BAP Pharma als exklusiver Partner von Agenus die Koordination der weltweiten Aktivitäten im Rahmen des BOT+BAL-Zugangsprogramms, einschließlich der Bearbeitung von Programmanfragen, der Fallkoordination, der Vertriebslogistik und der damit verbundenen Zahlungsabwicklung.
Dazu gehören das französische AAC-Verfahren sowie kostenpflichtige NPPs in bestimmten Ländern außerhalb der USA. Wie zuvor angekündigt hat Agenus mehr als 270 Anfragen von Ärzten aus über 30 Ländern zu diesen Zugangswegen erhalten.
„Ärzte zeigen weltweit großes Interesse an BOT+BAL im Rahmen autorisierter Early-Access-Programme. Ausschlaggebend sind dabei der wachsende Datenbestand aus klinischen Studien sowie der dringende Bedarf an wirksamen Behandlungsmöglichkeiten für Patienten mit schweren Krebserkrankungen“, erklärt Garo H. Armen, PhD, Chairman und CEO bei Agenus. „Unsere exklusive Partnerschaft mit BAP Pharma stärkt die Infrastruktur dieser Programme und bekräftigt unseren Anspruch, verantwortungsbewusst und effizient zu handeln. In Ländern, in denen der Zugang gesetzlich erlaubt ist, sehen wir uns moralisch verpflichtet, einen angemessenen und regelkonformen Zugang für Patienten zu gewähren, deren Ärzte nach alternativen Behandlungsmöglichkeiten suchen.“
Das französische AAC-Programm bietet geeigneten Patientinnen und Patienten mit metastasiertem kolorektalem Karzinom im Stadium MSS ohne aktive Lebermetastasen, mit platinresistentem oder platinrefraktärem Eierstockkrebs sowie mit bestimmten fortgeschrittenen Weichteilsarkomen auf der Grundlage eines national definierten Protokolls einen stationären und vollständig von der Regierung erstatteten Zugang zu BOT+BAL. Diese Patienten leiden in der Regel an Krebserkrankungen im fortgeschrittenen Stadium, bei denen die etablierten Behandlungsmöglichkeiten bereits ausgeschöpft sind. Außerhalb Frankreichs kann BOT+BAL in einigen Ländern im Rahmen kostenpflichtiger NPPs verfügbar sein, die von behandelnden Ärzten initiiert werden und den nationalen Vorschriften unterliegen. Dies gilt insbesondere dann, wenn behandelnde Ärzte auf der Grundlage der bisher erhobenen klinischen Daten, des medizinischen Bedarfs und der geltenden regionalen Anforderungen zu dem Ergebnis kommen, dass BOT+BAL für einen einzelnen Patienten oder eine einzelne Patientin angezeigt ist.
Das Interesse der Ärzte am BOT+BAL-Zugang ist in allen Regionen gewachsen. In zahlreichen Ländern Süd- und Mittelamerikas sowie in Europa, darunter Großbritannien, Schweiz, Griechenland, Brasilien und Argentinien, wurden Patientinnen und Patienten bereits im Rahmen gesetzlich zugelassener, kostenpflichtiger NPPs behandelt. Vorbehaltlich der lokalen Vorschriften ist eine Ausweitung auf Spanien geplant.
Im Rahmen dieser Zusammenarbeit wird BAP Pharma für diese Programme die weltweiten Aktivitäten von Agenus im Bereich Arzneimittelzugang koordinieren. BAP Pharma bringt eine langjährige Erfahrung im Bereich des weltweiten Arzneimittelzugangs, einen professionellen und reaktionsschnellen Ansatz bei der Zusammenarbeit mit Ärzten und Einrichtungen sowie die erforderliche Betriebsdisziplin mit, um die Logistik zu optimieren, die regionale Koordinierung zu stärken und behandelnde Ärztinnen und Ärzte bei der Bewältigung länderspezifischer regulatorischer Rahmenbedingungen zu unterstützen.
„Das Team von BAP Pharma verfügt über die Professionalität, Reaktionsfähigkeit und betriebliche Disziplin, die für die Unterstützung globaler Zugangsprogramme unverzichtbar sind“, betont Kamel Djazouli, M.D., Head of Medical Affairs bei Agenus. „Ihr Anspruch steht im Einklang mit unserem Engagement für Ärzte und Patienten, die den Zugang über autorisierte Wege anstreben. Wir sind überzeugt, dass diese Partnerschaft dazu beitragen wird, die Arbeitsabläufe für Gesundheitsteams weltweit zu verbessern.“
Bashir Parkar, M.D., Gründer von BAP Pharma, erklärt: „Die Ernennung zum exklusiven globalen Partner von Agenus ist ein wichtiger Meilenstein für BAP Pharma. Sie zeugt von dem Vertrauen in unsere Fähigkeit, regelkonforme, patientenorientierte Zugangslösungen in großem Maßstab bereitzustellen. Unsere Aufgabe ist es, komplexe Strukturen zu vereinfachen und Ärztinnen und Ärzten zu helfen, ihren Patientinnen und Patienten wichtige Therapien sicher, schnell und unter vollständiger Einhaltung der gesetzlichen Vorschriften bereitzustellen.“
Rebecca Bibby, Group Director, Medicines Access bei BAP Pharma, ergänzt: „Diese Partnerschaft zeigt, wie wichtig gut strukturierte globale Zugangsprogramme im heutigen klinischen und regulatorischen Umfeld sind. Durch die Bündelung der innovativen Therapien von Agenus mit der globalen operativen Expertise von BAP Pharma schaffen wir einen nahtloseren und zuverlässigeren Weg für Ärzte und Patienten, die Möglichkeiten für einen frühzeitigen Zugang erkunden wollen.“
Die Initiativen von Agenus im Bereich Early Access ergänzen die laufende klinische Entwicklungsstrategie für BOT+BAL, einschließlich der globalen Phase-3-Studie BATTMAN zur Behandlung von refraktärem metastasiertem kolorektalem Karzinom mit MSS/pMMR. Bis zur Erteilung der Zulassung ist BOT+BAL nur im Rahmen klinischer Studien und über genehmigte Zugangswege verfügbar, soweit dies nach den lokalen Rechtsvorschriften zulässig und möglich ist. Weitere Informationen über den Zugang für Patienten finden Sie auf der Website von Agenus unter Access to Investigational Medicines Policy.
Über Agenus
Agenus ist ein führendes Unternehmen auf dem Gebiet der Immunonkologie, das Krebserkrankungen mit einer umfassenden Pipeline immunologischer Wirkstoffe bekämpft. Im Jahr 1994 wurde das Unternehmen mit dem Ziel gegründet, die Gruppe der Patienten zu vergrößern, die von einer Krebsimmuntherapie profitieren. Dazu wird eine breite Palette von Antikörpertherapeutika, adoptiven Zelltherapien (über MiNK Therapeutics) und Adjuvantien in Kombination eingesetzt. Agenus verfügt über umfassende End-to-End-Entwicklungskapazitäten, die kommerzielle und klinische cGMP-Produktionsstätten, Forschung und Entwicklung sowie globale klinische Aktivitäten umspannen. Seinen Sitz hat Agenus in Lexington, im US-Bundesstaat Massachusetts. Weitere Informationen unter www.agenusbio.com oder @agenus_bio. Wichtige Informationen für Investoren werden regelmäßig auf unserer Website und in unseren sozialen Medien veröffentlicht.
Über Botensilimab (BOT)
Botensilimab (BOT) ist ein menschlicher Fc-verstärkter, multifunktionaler Anti-CTLA-4-Antikörper, der entwickelt wurde, um die angeborene und adaptive Anti-Tumor-Immunantwort zu verstärken. Das neuartige Design nutzt Wirkmechanismen, um die Vorteile der Immuntherapie auf „kalte“ Tumoren auszuweiten, die in der Regel schlecht auf die Standardbehandlung ansprechen oder gegenüber herkömmlichen PD-1/CTLA-4-Therapien und experimentellen Therapien resistent sind. Botensilimab verstärkt die Immunantwort für ein breites Spektrum von Tumorarten, indem es T-Zellen primt und aktiviert, intratumorale regulatorische T-Zellen herunterreguliert, myeloide Zellen aktiviert und Antworten des immunologischen Langzeitgedächtnisses induziert.
Etwa 1.200 Patienten wurden in klinischen Phase-1- und Phase-2-Studien mit Botensilimab und/oder Balstilimab behandelt. Botensilimab hat allein oder in Kombination mit dem in der Erprobung befindlichen PD-1-Antikörper Balstilimab von Agenus bei neun metastasierten Krebserkrankungen im fortgeschrittenen Stadium eine klinische Wirksamkeit gezeigt. Weitere Informationen über Botensilimab-Studien sind verfügbar unter www.clinicaltrials.gov.
Über Balstilimab (BAL)
Balstilimab ist ein neuartiges, vollständig menschliches monoklonales Immunglobulin G4 (IgG4), das entwickelt wurde, um die Interaktion von PD-1 (Programmed Cell Death Protein 1) mit seinen Liganden PD-L1 und PD-L2 zu blockieren. Es wurde bereits an mehr als 900 Patienten getestet und hat bei verschiedenen Tumorarten seine klinische Wirksamkeit und ein günstiges Verträglichkeitsprofil nachgewiesen.
Über BAP Pharma
BAP Pharma ist ein globaler Partner der Pharma- und Biotechbranche und bietet Lösungen für die Versorgung klinischer Studien sowie für den Zugang zu Arzneimitteln. Der Schwerpunkt des Unternehmens liegt auf dem Arzneimittelzugang. Über frühzeitige und strukturierte Zugangsprogramme weltweit ermöglicht BAP Pharma einen zeitnahen und regelkonformen Zugang zu wichtigen Therapien. Mit seinen Dienstleistungen reduziert das Unternehmen Komplexität und schafft Vertrauen bei Sponsoren, Ärztinnen und Ärzten sowie Patienten.
Website: https://bappharma.com/
LinkedIn: https://linkedin.com/company/bap-pharma
Zukunftsgerichtete Aussagen
Diese Pressemitteilung enthält zukunftsgerichtete Aussagen, die gemäß den Safe-Harbor-Bestimmungen der US-amerikanischen Wertpapiergesetze veröffentlicht werden, darunter Aussagen zu den Programmen Botensilimab und Balstilimab, zu den erwarteten regulatorischen Zeitplänen und Einreichungen sowie alle anderen Aussagen, die Begriffe wie „können“, „glauben“, „erwarten“, „vermuten“, „hoffen“, „beabsichtigen“, „planen“, „prognostizieren“, „schätzen“, „werden“, „etablieren“, „potenziell“, „Überlegenheit“, „Best-in-Class“ oder ähnliche Ausdrücke enthalten. Diese zukunftsgerichteten Aussagen unterliegen Risiken und Unwägbarkeiten, die dazu führen können, dass die tatsächlichen Ergebnisse erheblich von ihnen abweichen. Zu diesen Risiken und Unwägbarkeiten gehören unter anderem die Faktoren, die im Abschnitt „Risk Factors“ unseres jüngsten Jahresberichts auf Form 10-K für das Jahr 2025 und in den nachfolgenden Quartalsberichten auf Form 10-Q, die bei der Securities and Exchange Commission eingereicht wurden, beschrieben sind. Agenus empfiehlt Anlegern nachdrücklich, sich nicht unverhältnismäßig stark auf die in dieser Pressemitteilung enthaltenen zukunftsgerichteten Aussagen zu verlassen. Diese Aussagen gelten nur zum Zeitpunkt der Veröffentlichung der Pressemitteilung. Agenus übernimmt keine Verpflichtung, zukunftsgerichtete Aussagen zu aktualisieren oder zu revidieren, es sei denn, dies ist gesetzlich vorgeschrieben. Dieser Warnhinweis bezieht sich auf die Gesamtheit aller zukunftsgerichteten Aussagen.
Source: Agenus Inc. & BAP Pharma
Die Ausgangssprache, in der der Originaltext veröffentlicht wird, ist die offizielle und autorisierte Version. Übersetzungen werden zur besseren Verständigung mitgeliefert. Nur die Sprachversion, die im Original veröffentlicht wurde, ist rechtsgültig. Gleichen Sie deshalb Übersetzungen mit der originalen Sprachversion der Veröffentlichung ab.
Originalversion auf businesswire.com ansehen: https://www.businesswire.com/news/home/20260421799131/de/
Agenus – Investorenkontakt: 917-362-1370 | investor@agenusbio.com
Agenus – Medienkontakt: 781-674-4422 | communications@agenusbio.com
BAP Pharma – Medienkontakt: Jason De Kauwe | Jason.DeKauwe@bappharma.com
Original: Agenus ernennt BAP Pharma zum exklusiven globalen Partner für die BOT+BAL-Zugangsprogramme
US Market News
3月前
Agenus Reports Phase II Data Demonstrating Immune Reprogramming and Durable Survival with Botensilimab, Balstilimab and agenT-797 in PD-1 Refractory Gastroesophageal CancerApril 17, 2026 4:43 PM
Business Wire
First study combining botensilimab (BOT) and balstilimab (BAL) with agenT-797 in gastroesophageal cancer shows disease control rate (DCR) of 77% in patients and long-term survival beyond 20 months in a subset of heavily pretreated patients
Induction strategy linked to improvement in progression-free survival (PFS) and higher survival rates at 12 and 18 months, supported by evidence of immune activation and tumor reprogramming
Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced data from an investigator-initiated Phase II trial at Memorial Sloan Kettering Cancer Center, investigating botensilimab (BOT) and balstilimab (BAL) in combination with agenT-797, MiNK’s allo-iNKT cell therapy, ramucirumab and paclitaxel in patients with advanced PD-1 refractory gastroesophageal adenocarcinoma. The data are being presented at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 17-22, 2026, in San Diego, CA.
This Phase II trial, which is the first to combine BOT and BAL with agenT-797 in patients with gastroesophageal cancer who progressed after frontline therapy, was designed to explore the role of immune priming and treatment sequencing. Patients received induction with agenT-797 (alone or plus BOT/BAL) followed by the full combination regimen, or initiated the combination without induction, with longitudinal biomarker sampling throughout. In this study (n=17), the regimen delivered a 77% DCR with long-term survival beyond 20 months in a subset, and the induction arm showed meaningful gains in PFS (6.9 vs. 3.5 months; HR 0.19; p=0.015) and OS (9.5 vs. 5.2 months), with 43% of induction-treated patients alive at both 12 and 18 months—underscoring that durability and survival may be the most clinically relevant endpoints in this PD-1 refractory population.
“These findings illustrate the mechanistic synergy of agenT-797 with botensilimab and balstilimab in this PD-1 refractory setting,” said Dhan Chand, Ph.D., Vice President of Research at Agenus. “The induction approach promoted significant intratumoral infiltration of T cells and dendritic cells, the formation of organized tertiary lymphoid structures in on-treatment biopsy tissue from a patient with durable benefit, and activation of peripheral CD4 and CD8 T-cell populations. These changes are consistent with immune priming and tumor immune reprogramming, providing a biological rationale for the improved progression-free survival observed with the induction strategy.”
Efficacy findings from the Phase II (n=17) study included:
DCR was observed in 77% of all treated patients, and long-term survival beyond 20 months was seen in a subset
Patients who received induction cycle had longer progression-free survival (PFS) than those treated without induction, with median PFS of 6.9 months versus 3.5 months (HR 0.19; p=0.015), supporting the potential importance of immune priming and treatment sequencing.
Median overall survival (OS) was 9.5 months in the induction cohort versus 5.2 months without induction, with 43% of induction-treated patients alive at both 12 and 18 months, compared with 20% and 0%, respectively, in the non-induction cohort.
The study did not meet its primary endpoint of ORR; however, disease control and longer-term survival observed in a subset of patients support further study of this approach.
Correlative analyses showed that treatment with BOT, BAL, and agenT-797 was associated with significant intratumoral T cell and dendritic cell infiltration, the formation of organized tertiary lymphoid structures in on-treatment biopsies from a patient with prolonged benefit, and activation of peripheral CD4 and CD8 T cells.
The safety profile was consistent with the component agents. The most common treatment-emergent adverse events among all patients included fatigue, fever, diarrhea, anorexia, nausea and mucositis. Immune-related adverse events included dermatitis, colitis, gastritis, enteritis, hepatitis and hypothyroidism.
Additional analysis of the full biospecimen dataset is ongoing and is expected to provide further insight into immune mechanisms, optimal sequencing, and potential biomarkers that could help identify patients most likely to benefit.
Presentation Details:
Abstract Title: A phase II study of agenT-797, botensilimab (BOT) and balstilimab (BAL) in PD-1 refractory gastroesophageal cancer (GEC)
Presenter: Samuel L. Cytryn M.D.; Gastrointestinal Medical Oncologist, Memorial Sloan Kettering Cancer Center
Session Name: Phase II and Phase III Clinical Trials
Date/Time: April 20, 2026 | 2:00–5:00 PM PT; 5:00-8:00 PM EDT
Poster Section: 52
Abstract No.: CT166
About Agenus
Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.
About Botensilimab (BOT)
Botensilimab (BOT) is a human Fc enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.
Approximately 1,200 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov.
About Balstilimab (BAL)
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2025, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260417821181/en/
Investors
917-362-1370 | investor@agenusbio.com
Media
781-674-4422 | communications@agenusbio.com
Original: Agenus Reports Phase II Data Demonstrating Immune Reprogramming and Durable Survival with Botensilimab, Balstilimab and agenT-797 in PD-1 Refractory Gastroesophageal Cancer
US Market News
3月前
Agenus Announces Data from Phase II Study of BOT+BAL in Combination with agent-797 in PD-1 Refractory Gastroesophageal Cancer to be Presented at AACR 2026April 3, 2026 7:30 AM
Business Wire
Study highlights novel multi-mechanistic immunotherapy combination in checkpoint-refractory disease
Data expected to inform immune modulation, treatment sequencing, and durability of response across hard-to-treat tumors
Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced that data from an investigator-initiated Phase II trial conducted at Memorial Sloan Kettering Cancer Center will be presented at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 17–22, 2026, in San Diego, CA.
The study evaluates botensilimab (BOT) and balstilimab (BAL) in combination with agenT-797, an allogeneic iNKT cell therapy developed by MiNK Therapeutics, in patients with PD-1 refractory gastroesophageal cancer (GEC)—an area of significant unmet need where resistance to checkpoint inhibition remains a major clinical challenge.
Presentation Details:
Abstract Title: A phase II study of agenT-797, botensilimab (BOT) and balstilimab (BAL) in PD-1 refractory gastroesophageal cancer (GEC)
Presenter: Samuel L. Cytyrn, MD; Gastrointestinal Medical Oncologist, Memorial Sloan Kettering Cancer Center
Session Name: Phase II and Phase III Clinical Trials
Date/Time: April 20, 2026 | 2:00–5:00 PM PT; 5:00-8:00 PM EDT
Poster Section: 52
Abstract No.: CT166
About Agenus
Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.
About Botensilimab (BOT)
Botensilimab (BOT) is a human Fc enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.
Approximately 1,200 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov.
About Balstilimab (BAL)
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2025, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260403035898/en/
Investors
917-362-1370 | investor@agenusbio.com
Media
781-674-4422 | communications@agenusbio.com
Original: Agenus Announces Data from Phase II Study of BOT+BAL in Combination with agent-797 in PD-1 Refractory Gastroesophageal Cancer to be Presented at AACR 2026
US Market News
3月前
Agenus annonce le recrutement du premier patient dans l’essai mondial de phase III BATTMAN portant sur l’association immunothérapeutique BOT+BAL dans le cadre du cancer colorectal métastatique MSS ou pMMRApril 2, 2026 12:27 AM
Business Wire
Il s’agit d’une étude historique à visée d’enregistrement dont l’objectif est de redéfinir les critères d’évaluation utilisés pour le cancer colorectal métastatique (CCRm) de type MSS, qui représente environ 95 % des cas de CCRm
Le cancer colorectal est désormais la première cause de décès par cancer chez les adultes de moins de 50 ans
Agenus Inc. (Nasdaq : AGEN), un leader de l’innovation en immuno-oncologie, a annoncé aujourd’hui que le premier patient avait été recruté pour l’essai mondial historique de phase III BATTMAN (CO.33) (NCT07152821). Cette étude vise à évaluer l’association immunothérapeutique mise au point par Agenus de botensilimab (BOT) et de balstilimab (BAL) par rapport aux meilleurs soins adjuvants prodigués aux patients atteints d’un cancer colorectal métastatique (CCRm) réfractaire, inopérable, à microsatellites stables (MSS) et présentant une réparation efficace des mésappariements (mismatch repair proficient, pMMR), une population longtemps considérée comme résistante à l’immunothérapie.
Cette étude prendra la forme d’un essai clinique collaboratif piloté par le Canadian Cancer Trials Group (CCTG) au Canada, et sera menée au Canada, en France, en Australie et en Nouvelle-Zélande. Plus de cent sites y participeront, issus des réseaux universitaires coopérants du CCTG, de GI Cancer Trials en Australie et du consortium français Partenariat de Recherche en Oncologie Digestive (PRODIGE) (composé d’Unicancer, de GERCOR et la Fédération francophone de cancérologie digestive [FFCD]). L’essai BATTMAN (CO.33) servira d’étude de base pour l’essai d’enregistrement portant sur le traitement BOT+BAL, qui recrute actuellement environ 830 patients. Le recrutement mondial devrait s’achever rapidement, témoignant de l’enthousiasme sans précédent manifesté par les investigateurs et les patients à travers le monde, notamment du vif intérêt des centres et des médecins participant au programme d’accès précoce payant pour patients spécifiques d’Agenus et au programme d’AAC français.
« Le recrutement du premier patient dans l’étude BATTMAN marque une étape décisive pour Agenus et pour le programme BOT+BAL », a déclaré le Dr Steven O’Day, directeur médical d’Agenus. « Cette étude nous rapproche de notre objectif principal, à savoir la mise au point d’immunothérapies efficaces pour les patients qui disposent actuellement de peu d’options. Nous remercions nos partenaires du CCTG, de GI Cancer Trials en Australie et de PRODIGE, ainsi que les chercheurs dévoués, le personnel des sites et les patients qui sont le moteur de cet effort mondial. »
« Notre collaboration avec Agenus s’appuie sur des années de recherches menées au sein d’un groupe coopératif visant à proposer une immunothérapie aux patients atteints d’un cancer colorectal à microsatellites stables – c’est-à-dire ceux qui, historiquement, ne disposaient d’aucune option thérapeutique efficace », a confié pour sa part le Dr Chris O’Callaghan, DVM, PhD, chercheur principal du Canadian Cancer Trials Group. « Des études antérieures du CCTG semblent montrer qu’une double immunothérapie pourrait prolonger la survie, même en cas de tumeurs réfractaires. L’ampleur et la durabilité des réponses observées avec le botensilimab et le balstilimab dans ces études justifient leur évaluation dans le cadre d’un essai de phase 3. »
« L’enthousiasme des chercheurs s’est avéré remarquable : quelques jours seulement après le dépôt de la demande auprès de Santé Canada, les principaux centres du Canada se sont empressés de lancer l’étude. Nous sommes impatients de contribuer à faire avancer cet effort mondial et, peut-être, de changer la donne pour les patients ayant épuisé toutes les autres options thérapeutiques », a ajouté le Dr Jonathan Loree, MD, MSc, FRCPC, président de l’essai CO.33.
À propos de l’essai BATTMAN (CO.33)
L’essai BATTMAN (CCTG CO.33) (NCT07152821) est une étude mondiale de phase III, randomisée et contrôlée, visant à évaluer le botensilimab (BOT) associé au balstilimab (BAL) par rapport aux meilleurs soins de soutien chez des patients atteints d’un cancer colorectal réfractaire, non résécable, à des microsatellites stables (MSS) et présentant une réparation efficace des mésappariements (pMMR). Piloté par le Canadian Cancer Trials Group (CCTG), cet essai clinique coopératif international recrutera environ 830 patients répartis dans plus de cent centres au Canada, en France, en Australie et en Nouvelle-Zélande. Parmi les réseaux universitaires participants figurent le CCTG, le GI Cancer Trials et le Partenariat de Recherche en Oncologie Digestive (PRODIGE) en France, soutenu par UNICANCER. Cette étude, qui vise à permettre l’enregistrement du traitement, est conçue pour appuyer d’éventuelles demandes d’autorisation de mise sur le marché de l’association BOT+BAL pour cette population de patients difficiles à traiter. Les patients souhaitant en savoir plus sur l’étude, notamment sur les critères d’éligibilité et les modalités d’inscription, peuvent consulter le lien suivant : https://www.ctg.queensu.ca/patients/colorectal-cancer-clinical-trial-co33.
À propos d'Agenus
Agenus est une société pionnière d'immuno-oncologie dédiée au développement d'un large vivier d'agents immunologiques contre le cancer. Créée en 1994, l'entreprise s'est donné pour mission d'élargir les populations de patients atteints d'un cancer ayant accès à l'immunothérapie par des approches combinées, à partir d'un portefeuille diversifié d'anticorps thérapeutiques, de thérapies cellulaires adoptives (via MiNK Therapeutics) et d'adjuvants. Basée à Lexington, dans le Massachusetts (États-Unis), Agenus exploite des capacités de développement de bout en bout, depuis des sites de fabrication BPFa clinique et commerciale ainsi que de recherche et de développement, et possède une empreinte opérationnelle clinique mondiale. Pour de plus amples renseignements, visitez le site www.agenusbio.com ou @agenus_bio. Les informations susceptibles d'être importantes pour les investisseurs seront régulièrement publiées sur notre site Internet et nos canaux de médias sociaux.
À propos du Canadian Cancer Trials Group (CCTG)
Le Canadian Cancer Trials Group (CCTG, ou Groupe canadien des essais sur le cancer) est un groupe de recherche coopératif spécialisé dans les essais cliniques sur le cancer. Il mène des essais de phase I à III visant à tester des traitements anticancéreux et adjuvants, au Canada et dans le reste du monde. Basé au niveau de l’Université Queen’s, le CCTG a, à ce jour, apporté son soutien à plus de 700 essais cliniques impliquant 100?000 patients issus de 40 pays sur six continents, grâce à un réseau mondial de 20?000 chercheurs et professionnels dédiés aux essais cliniques. Le CCTG est le réseau canadien de coordination des essais cliniques pour le NCTN (National Clinical Trials Network) américain et est un programme national de la Société canadienne du cancer. Son objectif est d’améliorer la survie et la qualité de vie des personnes atteintes d’un cancer. Pour en savoir plus, rendez-vous sur cctg.ca.
À propos du botensilimab (BOT)
Le botensilimab (BOT) est un anticorps anti-CTLA-4 multifonctionnel optimisé par Fc humain conçu pour améliorer les réponses immunitaires antitumorales innée et adaptative. Sa conception innovante tire parti de mécanismes d'action visant à étendre les bénéfices de l'immunothérapie aux tumeurs dites « froides », qui ne répondent généralement pas bien aux thérapies conventionnelles ou résistent aux thérapies PD-1/CTLA-4 classiques et expérimentales. Le botensilimab augmente les réponses immunitaires pour un large éventail de types de tumeurs : il amorce les lymphocytes T, régule à la baisse les lymphocytes T régulateurs dans les tumeurs et active les cellules myéloïdes pour induire une mémoire immunitaire à long terme.
Environ 1 200 patients ont déjà été traités avec le botensilimab et/ou le balstilimab dans des essais cliniques de phase 1 et 2. Utilisé seul ou en association avec le balstilimab, l'anticorps PD-1 expérimental d'Agenus, le botensilimab a montré des réponses cliniques dans neuf cancers métastatiques après plusieurs lignes de traitement. Pour plus d'informations sur les essais portant sur le botensilimab, visitez le site www.clinicaltrials.gov.
À propos du balstilimab (BAL)
Le balstilimab est une nouvelle immunoglobuline G4 monoclonale entièrement humanisée (IgG4) conçue pour empêcher la PD-1 (protéine 1 de mort cellulaire programmée) d'interagir avec ses ligands PD-L1 et PD-L2. Elle a été évaluée chez plus de 900 patients à ce jour et a montré une activité clinique et un profil de tolérabilité favorable dans plusieurs types de tumeurs.
Déclarations prospectives
Le présent communiqué de presse contient des déclarations prospectives qui sont énoncées sous réserve des règles d'exonération des lois fédérales américaines en matière de valeurs mobilières. Il s'agit notamment des déclarations concernant les programmes de développement du botensilimab et du balstilimab, des dépôts et des délais réglementaires attendus, et de toute autre déclaration contenant des termes quels que « pouvoir », « croire », « s'attendre à », « anticiper », « espérer », « avoir l'intention de », « planifier », « prévoir », « estimer », « établir », « potentiel », « supériorité », « meilleur de sa catégorie », et des expressions similaires, notamment au futur et au conditionnel, qui permettent d'identifier lesdites déclarations. Ces déclarations prospectives impliquent des risques et des incertitudes susceptibles d'entraîner une différence notable entre les résultats réels et ceux exprimés dans les déclarations prospectives. Ces risques et incertitudes incluent, sans s'y limiter, les facteurs décrits dans la section intitulée « Facteurs de risque » de notre rapport annuel le plus récent sur formulaire 10-K pour l'année 2024, et les rapports trimestriels subséquents sur formulaire 10-Q déposés auprès de la Securities and Exchange Commission. Agenus met en garde les investisseurs de ne pas placer une confiance excessive dans les déclarations prospectives contenues dans le présent communiqué de presse. Ces déclarations sont valables uniquement à la date du présent communiqué de presse, et Agenus ne s'engage aucunement à mettre à jour ou à réviser toute déclaration prospective, sauf dans la mesure exigée par la loi. Toutes les déclarations prospectives sont expressément qualifiées dans leur totalité par cet avertissement.
Le texte du communiqué issu d’une traduction ne doit d’aucune manière être considéré comme officiel. La seule version du communiqué qui fasse foi est celle du communiqué dans sa langue d’origine. La traduction devra toujours être confrontée au texte source, qui fera jurisprudence.
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Original: Agenus annonce le recrutement du premier patient dans l’essai mondial de phase III BATTMAN portant sur l’association immunothérapeutique BOT+BAL dans le cadre du cancer colorectal métastatique MSS ou pMMR
US Market News
3月前
Agenus Announces First Patient Enrolled in Global Phase 3 BATTMAN Trial of BOT+BAL Immunotherapy Combination in MSS or pMMR Metastatic Colorectal CancerApril 1, 2026 7:30 AM
Business Wire
A Landmark Registrational Study Aiming to Redefine Outcomes in MSS mCRC Which Represents Approximately 95% of Metastatic Colorectal Cancer Cases
Colorectal Cancer Has Become the Leading Cause of Cancer-related Death in Adults Under Age 50
Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced that the first patient has been enrolled in the landmark global phase 3 BATTMAN (CO.33) trial (NCT07152821). This study is evaluating Agenus’ immunotherapy combination of botensilimab (BOT) plus balstilimab (BAL) versus best supportive care in patients with refractory, unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC), a population long considered resistant to immunotherapy.
This study is being conducted as a cooperative group trial led by the Canadian Cancer Trials Group (CCTG) from Canada and run across Canada, France, Australia and New Zealand. More than 100 sites will participate across the academic cooperative networks of CCTG, GI Cancer Trials in Australia and France’s Partenariat de Recherche en Oncologie Digestive (PRODIGE) consortium (including Unicancer, GERCOR and FFCD). The BATTMAN (CO.33) trial serves as the registrational-enabling study for BOT+BAL enrolling approximately 830 patients and is expected to complete global enrollment quickly, reflecting the unprecedented investigator and patient enthusiasm worldwide, including strong interest from sites and physicians engaged through Agenus’ paid named patient and French AAC access programs.
“Enrollment of the first patient in the BATTMAN study marks a key milestone for Agenus and the BOT+BAL program,” said Dr. Steven O’Day, Chief Medical Officer, Agenus. “This study advances our goal of developing effective immunotherapies for patients who currently have few options. We’re grateful to our partners at CCTG, GI Cancer Trials in Australia, and PRODIGE and to the dedicated investigators, site staff, and patients driving this global effort.”
“Our collaboration with Agenus builds on years of cooperative-group research aimed at bringing immunotherapy benefits to patients with microsatellite-stable colorectal cancer—those historically left without effective options,” said Dr. Chris O’Callaghan, DVM, PhD, Senior Investigator, Canadian Cancer Trials Group. “Earlier CCTG studies suggested that doublet immunotherapy could extend survival even in cold tumors, and the magnitude and durability of responses seen with botensilimab and balstilimab in earlier studies warrant their investigation in a phase 3 trial.”
“The enthusiasm among investigators has been remarkable—within days of Health Canada submission, leading centers across Canada moved to open the study. We’re eager to advance this global effort and potentially transform outcomes for patients who have exhausted all other treatments,” said Dr. Jonathan Loree, MD, MSc, FRCPC, CO.33 Study Chair.
About the BATTMAN (CO.33) Trial
The BATTMAN (CCTG CO.33) (NCT07152821) trial is a global Phase 3, randomized, controlled study evaluating botensilimab (BOT) plus balstilimab (BAL) versus best supportive care in patients with refractory, unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) colorectal cancer. Conducted as an international cooperative group study led by the Canadian Cancer Trials Group (CCTG), the trial will enroll approximately 830 patients across more than 100 sites in Canada, France, Australia, and New Zealand. Participating academic networks include CCTG, the GI Cancer Trials, and France’s Partenariat de Recherche en Oncologie Digestive (PRODIGE), sponsored by UNICANCER. This registrational-enabling study is designed to support potential regulatory submissions for BOT+BAL in this difficult-to-treat patient population. Patients interested in learning more about the study, including eligibility and enrollment information, can visit: https://www.ctg.queensu.ca/patients/colorectal-cancer-clinical-trial-co33.
About Agenus
Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.
About Canadian Cancer Trials Group (CCTG)
The Canadian Cancer Trials Group (CCTG) is a cancer clinical trials research cooperative that runs phase I–III trials to test anti-cancer and supportive therapies across Canada, and internationally. Headquartered at Queen’s University, CCTG has supported more than 700 trials enrolling 100,000 patients from 40 countries on 6 continents through a global network of 20,000 investigators and clinical trial staff. CCTG is the Canadian Coordinating Clinical Trial Network for the US NCTN and is a national program of the Canadian Cancer Society. CCTG’s aim is to improve survival and quality of life for all people with cancer. Learn more at cctg.ca.
About Botensilimab (BOT)
Botensilimab (BOT) is a human Fc enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.
Approximately 1,200 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov.
About Balstilimab (BAL)
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2024, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260401039214/en/
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Original: Agenus Announces First Patient Enrolled in Global Phase 3 BATTMAN Trial of BOT+BAL Immunotherapy Combination in MSS or pMMR Metastatic Colorectal Cancer
US Market News
3月前
Agenus to Host March 2026 Stakeholder Webcast Harnessing the Immune System to Advance BOT + BAL Across Tumor Types and Expand Patient AccessMarch 26, 2026 4:52 PM
Business Wire
Webcast on Tuesday, March 31, 2026, at 4:30 p.m. ET
Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in immuno-oncology, today announced it will host its March Stakeholder Webcast focused on continued progress of its botensilimab and balstilimab (BOT+BAL) immunotherapy program and will provide an update on the Company’s patient access programs, development across tumor types, and key priorities for 2026.
The session will be moderated by Garo H. Armen, PhD, Founder, Chairman, and Chief Executive Officer of Agenus, and will conclude with a live Q&A.
Featured Topics and Speakers
Strategic Direction: Advancing BOT+BAL
Garo Armen, PhD
Founder, Chairman, and Chief Executive Officer, Agenus
Dr. Armen will open the session by discussing Agenus’ mission to harness the immune system across tumor types and the urgency of advancing new options for patients with historically treatment-resistant cancers. He will also outline key priorities for 2026 as momentum continues to build across the BOT+BAL program.
Clinical Progress: Durability and Consistency Across Tumors
Steven J. O’Day, MD
Chief Medical Officer, Agenus
Dr. O’Day will provide a clinical perspective on the durability and consistency of BOT+BAL across tumor types, including in historically immunotherapy-resistant cancers. He will also highlight how these data are informing ongoing development and later-stage trials.
Access and Execution: Expanding Patient Through Available Global Programs
Kamel Djazouli, MD
Head, Medical Affairs, Agenus
Dr. Djazouli will provide an update on Agenus’ global access programs, including the France AAC and Named Patient Programs, and how they are enabling treatment for patients with limited options.
Stakeholder Briefing Details:
Registration Link: https://vimeo.com/event/5828543
Live webcast link will be provided once registration is completed.
Submit questions in advance at: https://app.sli.do/event/qBiptRwcnamAfzRhiQnExc
This session marks the second event in Agenus’ 2026 Stakeholder Briefing Series, building on prior discussions regarding BOT+BAL’s clinical progress, patient access pathways, and Agenus corporate milestones.
About Agenus
Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.
About Botensilimab (BOT)
Botensilimab is a multifunctional, human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.
Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. Approximately 1,200 patients have been treated across the botensilimab/balstilimab program in phase 1 and phase 2 clinical trials. For more information about botensilimab trials, visit www.clinicaltrials.gov.
About Balstilimab (BAL)
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in >900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the botensilimab and balstilimab clinical programs, expected trial initiations and regulatory plans, and the potential benefits of the combination therapy. Words such as “may,” “believes,” “expects,” “anticipates,” “hopes,” “intends,” “plans,” “forecasts,” “estimates,” “will,” “potential,” and similar expressions are intended to identify forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results to differ materially from current expectations. Factors that could cause actual results to differ include, but are not limited to, those described under the “Risk Factors” section of Agenus’ most recent Annual Report on Form 10-K for 2025 and subsequent Quarterly Reports on Form 10-Q filed with the SEC. Agenus cautions investors not to place undue reliance on forward-looking statements in this release, which speak only as of the date of this announcement. The company undertakes no obligation to update or revise these statements, except as required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260326480611/en/
Investors
917-362-1370 | investor@agenusbio.com
Media
781-674-4422 | communications@agenusbio.com
Original: Agenus to Host March 2026 Stakeholder Webcast Harnessing the Immune System to Advance BOT + BAL Across Tumor Types and Expand Patient Access
US Market News
4月前
Agenus Announces Upcoming AACR 2026 Presentation Evaluating Botensilimab Plus Balstilimab in First-Line MSS Metastatic Colorectal CancerMarch 17, 2026 4:40 PM
Business Wire
A novel, chemo-sparing strategy (BBoPCO): introducing BOT+BAL in 1L MSS mCRC to extend survival and reduce use of cytotoxic chemotherapy
Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, today announced that preliminary results from an investigator-sponsored study evaluating botensilimab (BOT) in combination with balstilimab (BAL) in first-line microsatellite stable colorectal cancer (MSS CRC) will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place April 18–23 in San Diego, CA.
The BBoPCO study (Botensilimab and Balstilimab Optimization in Colorectal Cancer; NCT06268015) is the first trial of its kind to advance a combination immunotherapy approach in the first-line setting for MSS mCRC, evaluating BOT+BAL in patients without liver, bone, or brain metastases—a population historically resistant to immunotherapy. This investigator-sponsored study was expanded to a Phase 2 and reflects a growing shift toward introducing immunotherapy earlier in the disease course, with the goal of harnessing the immune system to reduce reliance on chemotherapy and improve durability of response.
Colorectal cancer remains a leading cause of cancer-related death worldwide, with rising incidence in younger populations, and treatment continues to rely heavily on intensive, toxic chemotherapy regimens that can significantly impact quality of life, with neuropathy, organ toxicity, decrease fertility, among others. Despite advances, patients with MSS mCRC, which accounts for approximately 95% of metastatic cases, have seen limited benefit from conventional immunotherapy, underscoring a critical unmet need.
Botensilimab, an Fc-enhanced multifunctional anti-CTLA-4 antibody, is designed to activate both innate and adaptive immune responses, while balstilimab (anti–PD-1) is designed to sustain immune activity. Together, the combination is intended to target complementary immune pathways and expand the potential of immunotherapy in traditionally “cold” tumors.
The BBOpCo study adds to a growing body of research evaluating BOT+BAL across earlier lines of therapy and in settings where immune activation may have greater impact.
Presentation Details:
Poster Presentation Title: Preliminary results of first-line botensilimab (BOT) and balstilimab (BAL) optimization in microsatellite stable colorectal cancer (MSS CRC) without liver, bone, or brain metastasis (BBOpCo)
Presenting Author: Nicholas C. DeVito MD, Duke University, Assistant Professor of Medicine, Duke University, Division of Medical Oncology
Abstract No.: CT184
Session Title: Phase I Clinical Trials
Session Date: Tuesday, April 21, 2026
Session Time: 9:00AM – 12:00 PM PT / 12:00-3:00 PM ET
Location: Poster Section 50
Board No: 6
About Agenus
Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.
About Botensilimab (BOT)
Botensilimab (BOT) is a human Fc enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.
Approximately 1,200 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov.
About Balstilimab (BAL)
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2024, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
Source: Agenus Bio
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Original: Agenus Announces Upcoming AACR 2026 Presentation Evaluating Botensilimab Plus Balstilimab in First-Line MSS Metastatic Colorectal Cancer
US Market News
4月前
Agenus Reports 2025 Results; BOT+BAL Advances to Phase 3 and Early Access Programs Expand Globally with Initial Revenues RecognizedMarch 16, 2026 7:30 AM
Business Wire
Early access programs expand globally: 200+ physician inquiries across 30+ countries; $4.2M in initial program revenue recognized
CRC leads BOT+BAL clinical development: 42% two-year overall survival and ~21-month median overall survival in heavily pretreated microsatellite stable (MSS) metastatic CRC (mCRC) patients
BATTMAN Phase 3 registrational trial underway: First global next-generation CTLA-4/PD-1 combination registrational trial in refractory MSS mCRC
France expands reimbursed AAC access: Metastatic ovarian cancer and sarcoma added alongside MSS mCRC
Zydus collaboration strengthens balance sheet and manufacturing capacity: Strategic capital and dedicated U.S. biologics production secured to support BOT+BAL development for commercialization
Agenus Inc. (Nasdaq: AGEN) today reported financial results for the fourth quarter and full year ended December 31, 2025, highlighting progress for the botensilimab (BOT) plus balstilimab (BAL) immunotherapy program across patient access, clinical execution, and commercial readiness. BOT+BAL is a next-generation CTLA-4/PD-1 immunotherapy combination which activates both innate and adaptive immunity and has demonstrated immunotherapy benefit in tumors historically resistant to checkpoint inhibition.
The BOT+BAL program entered global Phase 3 evaluation in refractory microsatellite-stable (MSS) metastatic colorectal cancer (mCRC), expanded through regulatory-authorized early access pathways in multiple countries and recognized initial revenue associated with treatment supplied through these programs while preparing for potential future regulatory submissions in the United States and Europe.
"BOT+BAL is beginning to stand out for the reasons that matter most; patients with few options are actively seeking access, physicians are gaining experience with the regimen, and the clinical foundation continues to strengthen," said Garo H. Armen, PhD, Chairman and CEO of Agenus. "When real-world interest and clinical relevance start to align, conviction builds. We believe BOT+BAL has the potential to become an important new immunotherapy franchise in CRC and across other difficult-to-treat cancers."
Key Business Highlights
Early Access Programs Expand Patient Reach and Build Physician Experience
In parallel with clinical development, Agenus has begun providing BOT+BAL through regulatory-authorized early access pathways in certain countries. These programs are designed to enable treatment for patients with serious diseases who have exhausted approved therapies while allowing physicians to gain experience with the investigational combination in real-world clinical settings.
France AAC Early Access Program:
France’s national Autorisation d’Accès Compassionnel (AAC) program provides hospital-based access to BOT+BAL for eligible patients with certain refractory cancers, with treatment reimbursed through the national health system. BOT+BAL was first authorized through the national AAC protocol in MSS mCRC with non-liver metastases (NLM) in September 2025 and was expanded to include platinum-resistant ovarian cancer (PROC) and soft-tissue sarcomas (STS) in January 2026. The expansion broadens reimbursed access across multiple difficult-to-treat tumors and adds to the clinical experience with BOT+BAL in France.
Global Paid Named-Patient Programs (NPP):
Outside France, BOT+BAL may be available in select countries through paid named-patient programs where permitted by local regulations and initiated at the request of treating physicians. Depending on local requirements, access may involve out-of-pocket payment and/or special insurance arrangements.
Initial BOT+BAL Revenues from Paid Early Access Programs
Across both access programs, Agenus has received over 200 inquiries from more than 30 countries. In the year ended December 31, 2025, Agenus recognized approximately $4.2 million in net revenue from the AAC and paid NPP programs, after consideration of estimated government rebates. Reimbursed treatment in France and paid named-patient activity in other markets are providing additional clinical experience and data ahead of potential approvals in major regions.
Clinical Data Reinforce BOT+BAL Potential
Clinical data generated in 2025 and early 2026 continued to support the development of BOT+BAL as a differentiated, next-generation CTLA-4/PD-1 immunotherapy combination for cancers historically resistant to checkpoint inhibition. The clinical dataset, now spanning more than 1,200 patients across nine tumor types, is most mature in CRC while continuing to expand across other immunologically “cold” tumors. Additional updates from ongoing company and investigator sponsored trials, including Phase 2 neoadjuvant CRC trials, are expected in 2026.
Key highlights from 2H 2025 and early 2026 include:
MSS metastatic colorectal cancer (ESMO-GI 2025):
42% two-year overall survival (OS) and median overall survival of approximately 21 months in patients with heavily pretreated MSS mCRC without active liver metastases treated with BOT+BAL; previously reported data from available standard of care therapies demonstrated a median OS of 10-14 months.
Pan-tumor activity (ESMO 2025):
In more than 400 heavily pretreated patients (median 3 prior lines of treatment) across more than nine tumor types, BOT+BAL demonstrated approximately 39% two-year OS, including activity in metastatic colorectal, ovarian, sarcoma, PD(L)-1 refractory NSCLC, and hepatocellular cancers.
AACR-IO biomarker analysis (AACR-IO 2026):
Integrated analysis of systemic inflammation and tumor immune features identified biologically distinct patient subgroups with differential survival outcomes and outperformed conventional biomarkers such as PD-L1 and tumor mutational burden.
These data support the differentiated immune-modulating mechanism of the BOT+BAL combination and reinforce its potential across immunologically “cold” tumors.
Phase 3 BATTMAN MSS mCRC Registrational Trial Initiated
The BATTMAN (CCTG CO.33, NCT07152821) trial is the first global Phase 3 study evaluating the next-generation CTLA-4-based immunotherapy combination in patients with refractory MSS/mismatch repair proficient (pMMR) mCRC who have exhausted other available options. MSS CRC represents approximately 95% of mCRC cases and has historically shown limited benefit from immunotherapy.
The international cooperative-group study is led by the Canadian Cancer Trials Group (CCTG), with participation from leading academic networks including CCTG, GI Cancer Trials in Australia, and France's PRODIGE consortium.
The study is expected to enroll approximately 830 patients across more than 100 sites in Canada, France, Australia and New Zealand through leading cooperative group networks and is designed to support potential regulatory filings in the United States, Europe, Canada and other geographies.
Zydus Collaboration Strengthens Manufacturing, U.S. Infrastructure and Balance Sheet
In January 2026, Agenus closed its previously announced strategic collaboration with Zydus Lifesciences, providing strategic capital and dedicated biologics manufacturing capacity to support clinical development, authorized access programs and future commercial supply of BOT+BAL. Zydus paid $91 million of upfront capital at the close of the transaction, less certain adjustments. These adjustments include reimbursable expenses, other required closing payments, including approximately $5.8 million of transaction expenses and $7.5 million placed into a twelve-month escrow.
In March 2026, a $20 million contingent payment was triggered based on initial BOT+BAL work orders.
The collaboration strengthens Agenus’ balance sheet while securing dedicated U.S. manufacturing infrastructure for the next stage of clinical, regulatory and commercial expansion.
Financial Results
Fourth Quarter and Full Year 2025
Metric
Fourth Quarter 2025
Full Year 2025
Pre-commercial product revenue
$3.2 million
$4.2 million
Other revenue, including non-cash royalty revenue
$31.1 million
$110.0 million
Operating income (loss)
$14.4 million
$(20.2) million
Net loss
$(10.6) million
$(3.1) million
Pre-commercial product revenue represents initial contributions associated with treatment of investigational BOT+BAL supplied through early access programs, including France’s AAC program which commenced in the fourth quarter 2025.
2026 Strategic Priorities
Expand patient access through French ACC and global NPP early access pathways
Advance regulatory filings in the U.S. and the EU
Advance enrollment in the Phase 3 BATTMAN trial
Complete additional clinical and translational data in neoadjuvant CRC and other tumor types
Strengthen balance sheet and commercial readiness
Webcast and Conference Call Information
As part of Agenus’ newly launched webcast series, the Company will host a Stakeholder Briefing Webcast to review corporate activities. Additional details will be announced prior to the event.
About Agenus
Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.
About BATTMAN CO.33 Phase 3 Trial
Agenus, in collaboration with the Canadian Cancer Trials Group (CCTG), is initiating a global Phase 3 trial evaluating the immunotherapy combination of botensilimab (BOT) and balstilimab (BAL) versus best supportive care (BSC) in patients with refractory, unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) colorectal cancer. This registrational study will be conducted as an international cooperative group trial, led by CCTG and supported by academic networks including GI Cancer Trials in Australia and PRODIGE (France), which comprises Unicancer, GERCOR, and FFCD. The trial will include more than 100 sites in Canada, France, Australia, and New Zealand.
Agenus’ Commitment to Patient Access
Until marketing authorization is granted, BOT+BAL is accessible only through clinical trials including the planned Phase 3 BATTMAN trial in refractory MSS colorectal cancer and authorized early access mechanisms where permitted and available under each country’s regulatory framework.
For eligible French patients treated in hospital under AAC meeting the pre-defined criteria, BOT+BAL is fully reimbursed by France’s national health system (Assurance Maladie). Reimbursement is structured as a single, upfront, course-based reimbursement per patient that covers the patient’s full course of therapy according to the national AAC protocol, rather than on a per-dose basis. Once a patient is authorized and treatment is initiated under the protocol, full course of treatment and all subsequent administrations are supplied without additional product charges. In line with AAC requirements, the maximum indemnity applicable to BOT+BAL is declared to the relevant French authorities.
Outside France, access may be available in select countries through paid named-patient programs, which may involve out-of-pocket payment and/or special insurance arrangements depending on local regulations and individual coverage decisions.
About Botensilimab (BOT)
Botensilimab (BOT) is a human Fc enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.
Approximately 1,200 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov.
About Balstilimab (BAL)
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2024, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
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917-362-1370 | investor@agenusbio.com
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781-674-4422 | communications@agenusbio.com
Original: Agenus Reports 2025 Results; BOT+BAL Advances to Phase 3 and Early Access Programs Expand Globally with Initial Revenues Recognized
US Market News
4月前
Agenus Triggers First $20M Contingent Payment Under Zydus Life Sciences Collaboration to Support BOT+BAL Manufacturing NeedsMarch 10, 2026 7:30 AM
Business Wire
Work orders for key CMC and production activities activate first contingent payment as global demand expands across clinical and paid compassionate access programs
Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced that it has triggered the first $20 million contingent payment under its previously disclosed strategic collaboration with Zydus Lifesciences Ltd.
The payment was triggered by contracted work orders for critical chemistry, manufacturing and controls (CMC) and production activities related to botensilimab (BOT) and balstilimab (BAL). These activities will allow Zydus to perform the initiation of its commercial supply of Agenus’ lead programs. They also include additional manufacturing work to satisfy regulatory requirements for BLA and MAA readiness, to build upon existing inventory in anticipation of increasing demand across clinical development programs, authorized early access pathways, and to support potential global commercialization.
This milestone marks the first operational activities between Agenus and Zylidac Bio LLC, the U.S.-based biologics manufacturing subsidiary of Zydus Life Sciences.
“This milestone reflects our commitment to progressing BOT and BAL to regulatory approval readiness, and to support our ongoing clinical development and paid compassionate access program needs,” said Garo H. Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. “As reimbursed access continues in France under the AAC framework and named patient programs expand in permitted countries and enrollment advances in the global BATTMAN Phase 3 trial, it is essential that we proactively align manufacturing capacity with anticipated demand. Our partnership with Zydus enables us to scale thoughtfully while maintaining capital discipline.”
Agenus currently maintains sufficient cGMP clinical-grade BOT and BAL drug product inventory to support the ongoing BATTMAN Phase 3 trial, the ANSM-authorized French access program (AAC) program, paid named patient programs in select countries where permitted, and ongoing investigator-sponsored trials. The newly initiated manufacturing activities are designed to supplement existing supply and position the company to meet expanding demand across paid compassionate access, development and potential future commercial settings.
Under the collaboration agreement, up to $50 million in contingent payments may be triggered by BOT and BAL production orders. The $20 million payment announced today is contractually allocated specifically for production and CMC-related activities. This structure enables Agenus to execute critical manufacturing work in support of its development and access programs without additional capital expenditures impacting its cash position.
The strategic collaboration between Agenus and Zydus, originally announced in June 2025 and closed in January 2026, provides Agenus with long-term U.S.-based biologics manufacturing capacity to support BOT+BAL’s global development and potential commercialization.
About Agenus
Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.
About Global Access Pathways
Until marketing authorization is granted, BOT+BAL is accessible only through clinical trials including the Phase 3 BATTMAN trial in refractory MSS colorectal cancer and authorized early access mechanisms where permitted and available under each country’s regulatory framework.
For eligible French patients treated in hospital under AAC meeting the pre-defined criteria, BOT+BAL is fully reimbursed by France’s national health system (Assurance Maladie). Reimbursement is structured as a single, upfront, course-based reimbursement per patient that covers the patient’s full course of therapy according to the national AAC protocol, rather than on a per-dose basis. Once a patient is authorized and treatment is initiated under the protocol, full course of treatment and all subsequent administrations are supplied without additional product charges. In line with AAC requirements, the maximum indemnity applicable to BOT+BAL is declared to the relevant French authorities.
Outside France, access may be available in select countries through paid named-patient programs, which may involve out-of-pocket payment and/or special insurance arrangements depending on local regulations and individual coverage decisions.
About Botensilimab (BOT)
Botensilimab (BOT) is a human Fc-enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.
Approximately 1,200 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. In France, botensilimab is accessible only through the ANSM-authorized AAC framework when used as BOT+BAL under the national protocol described above.
About Balstilimab (BAL)
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. In France, balstilimab is accessible only through the ANSM-authorized AAC framework when used as BOT+BAL under the national protocol described above.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding botensilimab and balstilimab, early access pathways, clinical development plans (including BATTMAN), and expected regulatory and clinical timelines, and any other statements containing the words “may,” “believes,” “expects,” “anticipates,” “hopes,” “intends,” “plans,” “forecasts,” “estimates,” “will,” and similar expressions intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2024, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
Source: Agenus Inc.
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Investors
917-362-1370 | investor@agenusbio.com
Media
781-674-4422 | communications@agenusbio.com
Original: Agenus Triggers First $20M Contingent Payment Under Zydus Life Sciences Collaboration to Support BOT+BAL Manufacturing Needs
US Market News
4月前
Agenus to Provide Fourth Quarter and Year-end 2025 Financial Report and Corporate UpdateMarch 4, 2026 4:30 PM
Business Wire
Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in immuno-oncology, today announced that the Company will release its fourth quarter and year-end 2025 financial results before the market opens on Monday, March 16, 2026.
Agenus will host a stakeholder briefing webcast in late March to spotlight key strategic plans, data milestones and provide an update on the global botensilimab (BOT) and balstilimab (BAL) development program.
About Agenus
Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.
About Botensilimab (BOT)
Botensilimab (BOT) is a human Fc enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.
Approximately 1,200 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov.
About Balstilimab (BAL)
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2024, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
Source: Agenus Bio
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Media: 781-674-4422 | communications@agenusbio.com
Original: Agenus to Provide Fourth Quarter and Year-end 2025 Financial Report and Corporate Update
US Market News
5月前
Agenus Presents Biomarker Data Demonstrating Survival Stratification in MSS mCRC and Other Immunologically Cold Tumors Treated with BOT+BALFebruary 19, 2026 3:15 PM
Business Wire
Integrated analysis of systemic inflammation and tumor immune features identifies biologically distinct patient subgroups with differential survival outcomes, outperforming conventional biomarkers
Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, today announced new translational and clinical biomarker data from its Phase 1b C-800-01 trial (NCT03860272) evaluating botensilimab (BOT), an Fc-enhanced anti–CTLA-4 antibody, in combination with balstilimab (BAL), an anti–PD-1 antibody. The data were presented today at the American Association for Cancer Research Immuno-Oncology (AACR-IO) Conference in Los Angeles.
The retrospective analyses demonstrate that survival with BOT+BAL is associated with the balance of two opposing biological factors: systemic inflammation in the blood (associated with poorer outcomes) and tumor immune activity within the tumor microenvironment (TME) (associated with more favorable outcomes). Notably, BOT+BAL enabled clinical benefit even at levels of immune infiltration typically considered insufficient for conventional checkpoint inhibitors, suggesting the Fc-enhanced mechanism lowers the threshold of baseline immunity required for activity. Integrating blood-based inflammatory markers with tumor immune features improved overall survival stratification in microsatellite-stable metastatic colorectal cancer (MSS mCRC), a population historically resistant to conventional checkpoint inhibitors.
Traditional biomarkers such as PD-L1 expression and tumor mutational burden have shown limited predictive value in MSS mCRC. These findings suggest that a broader view of inflammatory and immune biology may better define patients most likely to benefit from next-generation immunotherapy.
Durable Clinical Activity Across Historically “Cold” Tumor Types
In 341 efficacy-evaluable patients with advanced, treatment-refractory cancers and available biomarker data (data cutoff December 13, 2025):
Objective response rate (ORR): 17%
Clinical benefit rate (CBR): 26%
Median overall survival (OS): 17.2 months
24-month overall survival rate: 38%
Clinical activity was observed across tumor types commonly considered immunologically “cold,” including MSS mCRC, ovarian cancer, sarcoma, and PD-1 relapsed or refractory non-small cell lung cancer. Notably, durable benefit was observed in patients both naïve to and resistant/refractory to prior anti–PD-(L)1/CTLA-4 therapies.
To better understand the biological drivers of these outcomes, integrated translational analyses evaluated both systemic inflammation and tumor microenvironment immune features.
Biomarker Insights Identify Patient Subgroups in Immunologically “Cold” Cancers
Systemic Inflammation Negatively Impacts Survival
Baseline indicators of systemic inflammation were significantly associated with shorter OS, including elevated neutrophil-to-lymphocyte ratio, C-reactive protein and other markers reflective of inflammatory and organ stress.
Even Low Immune-Infiltration of TME Associated with Longer Survival
Survival benefit was observed across immunologically “cold” tumors, including at low levels of tumor-infiltrating lymphocytes (≥34 cells/mm²), demonstrating activity beyond conventional checkpoint biomarker thresholds.
Integrated Blood and Tumor Biomarkers Improve Survival Stratification in MSS mCRC
Combining blood and tumor features distinguished biologically distinct MSS mCRC subgroups with markedly different survival outcomes (C-index up to 0.73).
Early Immune Activation Correlates with Benefit
Patients who experienced immune-mediated adverse events (imAEs) within the first 12 weeks of treatment demonstrated longer median OS (22.4 months vs. 13.7 months), consistent with distinct baseline immune features.
“These data show that outcomes with BOT+BAL are shaped by the interplay between systemic inflammation and tumor immune biology,” said Dhan Chand, PhD, Vice President of Research and Development at Agenus. “By integrating blood- and tumor-based features, we are establishing a biologically grounded approach to patient stratification in immunologically ‘cold’ cancers such as MSS colorectal cancer, where conventional biomarkers provide limited guidance. Notably, the activity observed at low levels of immune infiltration further underscores the differentiated immune-modulating profile of botensilimab.”
The poster (No. B036), titled “Systemic and Tumor-Microenvironment Inflammation Shape Outcomes in Patients with Immunologically Cold, Treatment-Refractory Tumors Treated with Fc-Enhanced Anti–CTLA-4 Botensilimab,” was presented during the General Poster Session and is available in the Publications section of the Company’s website at www.agenusbio.com/publications
About Agenus
Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.
About Phase 1b Study
C-800-01 (NCT03860272) is a multicenter Phase 1b clinical trial evaluating botensilimab in combination with balstilimab across advanced solid tumors. The trial enrolled over 400 patients with refractory disease and included tumor types with limited or no responsiveness to prior checkpoint inhibitors. Endpoints included objective response rate (ORR), duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).
About Botensilimab (BOT)
Botensilimab (BOT) is a human Fc enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.
Approximately 1,200 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov.
About Balstilimab (BAL)
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2024, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260219390538/en/
Investors : 917-362-1370 | investor@agenusbio.com
Media: 781-674-4422 | communications@agenusbio.com
Original: Agenus Presents Biomarker Data Demonstrating Survival Stratification in MSS mCRC and Other Immunologically Cold Tumors Treated with BOT+BAL
US Market News
5月前
Agenus to Present New Data at AACR-IO Exploring Systemic and Tumor Inflammation Biomarkers with BOT/BAL in Immunologically Cold TumorsFebruary 9, 2026 1:00 PM
Business Wire
Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, today announced that new translational and clinical biomarker analyses from its botensilimab (BOT) immunotherapy program have been accepted for poster presentation at the American Association for Cancer Research- Immuno-Oncology (AACR-IO) Conference, taking place in Los Angeles, CA on February 18–21, 2026.
The abstract, titled “Systemic and tumor-microenvironment inflammation shape outcomes in patients with immunologically cold, treatment-refractory tumors treated with Fc-enhanced anti–CTLA-4 botensilimab,” evaluates how systemic inflammatory markers, tumor microenvironment (TME) immune activity, and peripheral immune cell states are associated with clinical outcomes in patients treated with BOT alone or in combination with balstilimab (BAL).
Botensilimab is an Fc-enhanced multifunctional anti-CTLA-4 antibody designed to help prime and activate the immune system, while BAL is an anti-PD-1 antibody designed to help sustain immune activity against cancer. Together, BOT+BAL targets complementary immune pathways and is being evaluated across multiple solid tumors, including immunologically “cold” or treatment-refractory cancers.
Presentation Details:
Poster Presentation Title: Systemic and tumor-microenvironment inflammation shape outcomes in patients with immunologically cold, treatment-refractory tumors treated with Fc-enhanced anti–CTLA-4 botensilimab
Presenting Author:
Chloe Delepine PhD, Biomarker Operations, Agenus
Session Date:
Thursday, February 19, 2026
Session Time:
12:15-3:15PM PT / 3:15-6:15 PM ET
Location:
JW Marriott, Platinum Ballroom
Poster Session:
Poster Session B
About Agenus
Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.
About Botensilimab (BOT)
Botensilimab (BOT) is a human Fc enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.
Approximately 1,200 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov.
About Balstilimab (BAL)
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2024, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
Source: Agenus Bio
View source version on businesswire.com: https://www.businesswire.com/news/home/20260209269639/en/
Investors : 917-362-1370 | investor@agenusbio.com
Media: 781-674-4422 | communications@agenusbio.com
Original: Agenus to Present New Data at AACR-IO Exploring Systemic and Tumor Inflammation Biomarkers with BOT/BAL in Immunologically Cold Tumors
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