US Market News
2週前
Aptevo Therapeutics Appoints Mary J. Janatpour, Ph.D., as Senior Vice President & Chief Scientific OfficerMay 28, 2026 8:05 AM
ACCESS NewswireExperienced oncology R&D leader appointed to support Aptevo's expanding oncology pipeline and new radiopharmaceutical development strategySEATTLE, WA / ACCESS Newswire / May 28, 2026 / Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, today announced the appointment of Mary J. Janatpour, Ph.D., as Senior Vice President & Chief Scientific Officer.Dr. Janatpour brings more than 25 years of oncology research and development leadership across biotechnology and pharmaceutical organizations, with deep expertise spanning target discovery, translational science, and pipeline strategy. In this role, she will lead Aptevo's research and preclinical development efforts and play a key role in advancing the Company's expanding pipeline of multispecific therapeutics."Mary joins Aptevo at a pivotal moment as we continue to focus clinically on mipletamig while advancing a broader preclinical strategy that includes our recently announced radiopharmaceutical therapeutic collaboration with Niowave and our expanding multispecific oncology pipeline," said Jeff Lamothe, President and Chief Executive Officer of Aptevo. "The Niowave collaboration marks an exciting new direction for Aptevo and reflects the broader potential of our ADAPTIR™ and ADAPTIR-FLEX™ platforms to support innovation across multiple oncology modalities. Mary's leadership, scientific depth, and experience advancing oncology programs from discovery toward clinical development will be important as we execute across our current clinical priorities, pursue this new radiopharmaceutical opportunity, and continue building the next generation of multispecific cancer therapeutics."Dr. Janatpour has held senior scientific leadership roles across both large biopharmaceutical organizations and emerging biotechnology companies, giving her a rare combination of deep oncology research expertise and hands-on experience building innovative programs in fast-moving development environments. Earlier in her career, she held leadership positions at the Novartis Institutes for Biomedical Research, Schering-Plough Biopharma and Chiron, where her work focused on oncology biologics target identification and validation. The latter half of her career has been focused on immuno-oncology, where she has led oncology discovery and translational strategy for established and emerging biotechnology companies advancing novel therapeutic molecules and platforms.Across her career, Dr. Janatpour has helped shape and advance multiple oncology portfolios spanning early discovery through clinical translation, with expertise in immuno-oncology, antibody-based therapeutics and innovative platform technologies. She has also served as a scientific advisor and board member to several biotechnology organizations."Aptevo's differentiated approach to controlled immune engagement, together with its expanding multispecific pipeline, positions the company to make a meaningful impact in cancer treatment," said Dr. Janatpour. "I'm thrilled to join at this stage of momentum and look forward to advancing a pipeline that has the potential to translate innovative science into real benefit for patients."Dr. Janatpour holds a Ph.D. in Biomedical Sciences from the University of California, San Francisco, and completed her postdoctoral training in Immunology at the DNAX Research Institute.About Aptevo Therapeutics Inc.Aptevo Therapeutics Inc. (Nasdaq:APVO) is a clinical-stage biotechnology company focused on developing novel bispecific and trispecific immunotherapies for the treatment of cancer. The Company has two clinical candidates and six preclinical candidates designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIR™ and ADAPTIR-FLEX™. Aptevo's mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit www.aptevotherapeutics.com.Safe Harbor StatementThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety, tolerability and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for treatment of disease, its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, statements related to the progress of Aptevo's clinical programs, including statements related to anticipated clinical and regulatory milestones, the potential benefits, timing, scope and outcomes of the co-development collaboration with Niowave, including the ability to develop radiopharmaceutical candidates, statements regarding the therapeutic and commercial potential of radiopharmaceutical therapies generally, development and continued development of Aptevo's current and potential future molecules, including multispecific oncology therapies, statements related to Aptevo's ability to generate stockholder value, whether Aptevo will continue to have momentum in its business in the future, and any other statements containing the words "may," "continue to," "believes," "knows," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement.There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarterly period March 31, 2026, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances.ContactMiriam Weber Miller
VP, Investor Relations and Corporate Communications
Aptevo Therapeutics
Email: IR@apvo.com or
US Market News
2週前
Aptevo and Niowave Launch Strategic Collaboration for Radiopharmaceutical Therapeutic Development, Includes Strategic Equity Investment by Niowave at ClosingMay 27, 2026 8:05 AM
ACCESS Newswire50/50 Strategic Collaboration Will Develop Up to Three Radiopharmaceutical ProgramsInnovation and Investment Continue to Accelerate Across Radiopharmaceutical OncologySEATTLE, WA AND LANSING, MI / ACCESS Newswire / May 27, 2026 / Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company developing novel multispecific immuno-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, and Niowave, Inc., a leader in radioisotope production and supply with established partnerships across the radiopharmaceutical ecosystem, today announced a 50/50 strategic collaboration to develop up to three radiopharmaceutical oncology programs.Niowave made an at-the-market equity investment in Aptevo at closing, representing an initial ownership position of 7.9%,[1] with the potential to build a meaningful equity stake of up to 19.99% through warrant exercises at a premium to the initial purchase and future purchases of Aptevo common stock. This structure aligns incentives between the two organizations and supports the long-term advancement of the collaboration."The collaboration between Aptevo and Niowave reflects a strategic expansion of Aptevo's development plan, and we are extremely pleased to be working with Niowave," said Jeff Lamothe, President and Chief Executive Officer of Aptevo. "We have established a strong foundation and clinical proof-of-concept with our multispecific assets, and this partnership enables us to extend that capability into radiopharmaceuticals, an increasingly important area of therapeutic development in oncology. By combining our targeting approach with Niowave's isotope capabilities, we are well positioned to explore new ways to address the complexity of many kinds of cancer.""This collaboration will deepen our radiopharmaceutical development capabilities and better position us to support current partners and the broader industry," said Mike Zamiara, Chief Executive Officer of Niowave. "Our investment reflects our confidence in the opportunity to combine Aptevo's targeting capabilities with Niowave's radioisotope production and supply expertise. Together, we expect to help advance new treatment options for patients with difficult-to-treat cancers."The deal marks Aptevo's expansion into radiopharmaceutical-based therapeutic development, a potential high-growth and increasingly validated area of oncology, and Niowave's first time investing in a therapeutic development program. By combining Aptevo's multispecific platforms with Niowave's radioisotope manufacturing and supply capabilities-an important advantage in a supply-constrained market-the companies' goal is to advance new approaches for cancer patients with high unmet need.Under the terms of the agreement, Aptevo will contribute assets from its proprietary multispecific antibody platforms, beginning with targeting assets directed against Nectin-4, together with associated development expertise. Expressed on the surface of cancer cells, Nectin-4 is a clinically validated cancer target with broad relevance across solid tumors. It is a logical initial target for a radiopharmaceutical approach, where a radioactive payload is directed to the tumor. Meanwhile, Niowave will provide radioisotopes and related manufacturing and supply capabilities, including Actinium-225 and additional radioisotopes. This approach gives both Aptevo and Niowave a practical first program that builds from an established target while applying Aptevo's multispecific engineering capabilities in a new way."Niowave brings critical expertise in radioisotope production and supply, which is essential to advancing this class of therapies," Lamothe added. "Their decision to support therapeutic development with an investment in our Company, reflects a shared commitment to building a focused and aligned collaboration with significant potential to impact the cancer treatment paradigm."The companies have designed and are ready to initiate the first stage of the collaboration, which will inform next steps and future development.The Radiopharmaceutical OpportunityRadiopharmaceutical therapies have emerged as a clinically validated area of oncology, supported by growing investment across the industry, including multi-billion-dollar transactions in emerging radiopharmaceutical companies by large pharmaceutical companies such as Novartis, Bristol Myers Squibb, Eli Lilly, and AstraZeneca. This activity underscores the important role of smaller, innovation-driven platforms in advancing the field.These therapies deliver targeted radiation directly to tumor cells and are increasingly being developed in combination with immunotherapy to address the complexity of treating a broad range of cancers.Alpha-emitting isotopes such as Actinium-225 release high-energy alpha particles over an extremely short distance. This targeted approach has generated significant interest in oncology because it has the potential to destroy cancer cells while limiting damage to surrounding healthy tissue.Development has been constrained by limited access to critical isotopes and manufacturing infrastructure, as well as the need for effective targeting strategies. Niowave is a leading manufacturer and supplier of isotopes with established relationships across the radiopharmaceutical ecosystem, reinforcing its role as a reliable isotope supply partner in a resource-constrained market. Aptevo's multispecific anti-cancer assets and immuno-oncology expertise enable precise targeting to support radiopharmaceutical development in complex tumor settings.About the CollaborationThe Aptevo-Niowave collaboration is structured as a 50/50 strategic collaboration to support the development of up to three radiopharmaceutical programs. The deal leverages Aptevo's multispecific platform and development expertise alongside Niowave's radioisotope capabilities to advance novel therapeutic candidates with the potential to address a range of difficult-to-treat cancers.About AptevoAptevo Therapeutics Inc. (Nasdaq:APVO) is a clinical-stage biotechnology company focused on developing novel bispecific and trispecific immunotherapies for the treatment of cancer. The Company has two clinical candidates and six preclinical candidates with different mechanisms of action designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIR™ and ADAPTIR-FLEX™. Aptevo's mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit www.aptevotherapeutics.com.About NiowaveFounded in 2005, Niowave, Inc. is a global leader in developing and operating superconducting electron linear accelerators and advancing radiochemistry procedures for medical isotope production. Headquartered in Lansing, Michigan, the company produces Actinium-225 and other isotopes to support the next generation of cancer treatments, with a mission to accelerate the fight against cancer through reliable, scalable supply.[1] Based on Aptevo's shares outstanding as of May 13, 2026 (Aptevo's most recent quarterly filing) and no exercise at closing of the warrants acquired by Niowave.Safe Harbor StatementThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, statements regarding: Aptevo's expectations about the activity, efficacy, safety, tolerability and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for the treatment of disease; its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms; statements related to the progress of Aptevo's clinical programs and anticipated clinical and regulatory milestones; the potential benefits, timing, scope and outcomes of the co-development collaboration with Niowave, including the ability to develop radiopharmaceutical candidates especially with Nectin-4 as the initial target for the collaboration, generate proof-of-concept data, and make program selection, prioritization and next-step development decisions; the availability, reliability, and scalability of radioisotope supply and manufacturing; the terms and anticipated benefits of Niowave's investment in Aptevo and any potential increase in ownership over time; Aptevo's ability to enter into additional strategic collaborations; and Aptevo's ability to generate stockholder value; and statements regarding the therapeutic and commercial potential of radiopharmaceutical therapies generally. Statements containing the words "may," "continue to," "believes," "knows," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement.There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems; adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2026, and its subsequent reports on Form 10-Q and current reports on Form 8-K. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances.CONTACT:Aptevo Therapeutics
Miriam Weber Miller
VP, Investor Relations and Corporate Communications
Email: IR@apvo.com or
US Market News
1月前
Aptevo Therapeutics Provides a 1Q26 Business Update; RAINIER on Track for 2026 Completion and Phase 2 Dose SelectionMay 13, 2026 8:05 AM
ACCESS NewswireMipletamig continues to perform, delivers 87% clinical benefit and 81% remission in frontline AML, with no CRS in frontline patientsExecutive leadership transition complete. Jeff Lamothe appointed CEO; Marvin White assumes Executive Chair$60 million equity line of credit enhances financial flexibility and extends access to capital through achievement of key catalysts into 2029SEATTLE, WA / ACCESS Newswire / May 13, 2026 / Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, today provided a business update."Aptevo is entering a defining period as a company, supported by growing clinical momentum, a committed leadership team, and a pipeline with the potential to create significant long-term value," said Jeff Lamothe, President and Chief Executive Officer of Aptevo. "Mipletamig continues to generate compelling frontline AML data, combining strong remission activity with a differentiated safety profile with the potential as an important addition to standard-of-care therapy. At the same time, we are continuing to advance our next generation of multispecific immunotherapy programs, including our emerging trispecific candidates, which are designed to address complex solid tumors through differentiated mechanisms and targeted immune modulation. We believe our ADAPTIR and ADAPTIR-FLEX platforms position Aptevo to expand into multiple high-value areas of oncology innovation. With meaningful clinical and strategic milestones ahead, financial flexibility to support execution, and increasing validation of multispecific approaches throughout the industry, we believe we are building from an increasingly strong foundation for future growth and value creation."RAINIER trial on track for completion and Phase 2 dose selection by year end.Mipletamig continues to generate strong data in frontline acute myeloid leukemia (AML) in combination with venetoclax + azacitidine. Across 31 evaluable patients (includes data through RAINIER Cohort 5, plus 4 patients from the previously completed dose expansion trial), the data has demonstrated continued efficacy, including:87% clinical benefit rate* that demonstrates broad anti-leukemia activity and blast reduction across response categories81% CR or CRi (remission), compared to 66.4% in the Phase 3 VIALE-A trial**65% achieved CR (complete remission), compared to 37% in the Phase 3 VIALE-A trial**No cytokine release syndrome (CRS), a common and often dose-limiting toxicity associated with similar therapies, has been observed in frontline patients to dateThe data also show that 52% of patients who achieved CR/CRi had blast reductions that reached the important measurable residual disease-negative level, a result that is typically associated with stronger, more durable responses.As the dataset continues to expand, efficacy and safety outcomes continue to deliver favorable results, further supporting mipletamig's potential in the frontline setting.*Clinical benefit rate: complete remission (CR), complete remission with incomplete hematologic recovery (CRi), and partial remission (PR)**Phase 3 VIALE-A trial evaluating venetoclax plus azacitidine in frontline intent-to-treat AML patients who were ineligible for intensive induction chemotherapy, the reported composite CR/CRi rate was 66.4%, and the CR rate was 37% (DiNardo et al., New England Journal of Medicine, 2020).Completed Leadership Transitions; Company Poised for a Defining YearAptevo entered 2026 with purposeful momentum, highlighted by a planned executive leadership transition designed to support the company's next phase of growth. Jeff Lamothe was appointed President and Chief Executive Officer, while Marvin White transitioned to Executive Chair. The move reflects continuity in strategy while positioning the organization for focused execution across clinical development, capital strategy, and long-term value creation.Q1 2026 Cash PositionAptevo had cash and cash equivalents totaling $14.5 million as of March 31, 2026. During the first quarter of 2026, the company raised $0.9 million, net, under the company's Standby Equity Purchase Agreements (SEPAs) with Yorkville. For additional APVO financial information and complete access to the company's filings, click here.Enhanced Financial Flexibility Supports Upcoming CatalystsDuring the quarter, Aptevo secured a $60 million SEPA, providing meaningful access to capital and extending financial flexibility as the company advances toward planned milestones. Management believes the facility better positions Aptevo to execute strategically, support ongoing development programs, and approach future opportunities from a position of greater strength.About Aptevo TherapeuticsAptevo Therapeutics Inc. (Nasdaq: APVO) is a clinical-stage biotechnology company focused on developing novel bispecific and trispecific immunotherapies for the treatment of cancer. The company has two clinical candidates. Mipletamig is currently being evaluated in RAINIER, a two-part Phase 1b/2 trial for the treatment of frontline acute myeloid leukemia in combination with standard-of-care venetoclax + azacitidine. Mipletamig has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act. ALG.APV-527, a bispecific conditional 4-1BB agonist active only upon simultaneous binding to 4-1BB and 5T4, is being co-developed with Alligator Bioscience and was most recently evaluated in a Phase 1 clinical trial for the treatment of multiple solid tumor types likely to express 5T4. The company has six preclinical candidates designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIR and ADAPTIR-FLEX. The Aptevo mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit www.aptevotherapeutics.com.Safe Harbor StatementThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety, tolerability and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for treatment of disease, its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, statements related to the progress of Aptevo's clinical programs, including statements related to anticipated clinical and regulatory milestones, whether further study of mipletamig in a Phase 1b dose optimization trial focusing on multiple doses of mipletamig in combination with venetoclax + azacitidine on a targeted patient population will continue to show remissions, whether further study of mipletamig in a Phase 1b dose-optimization trial will continue to report a favorable safety profile, let alone no instances of cytokine release syndrome, whether Aptevo's final trial results will vary from its earlier assessment, whether Aptevo's strategy will translate into an improved overall survival in AML, especially among patient subgroups with poor prognosis, whether further study of ALG.APV-527 across multiple tumor types will continue to show clinical benefit, the possibility and timing of interim data readouts for ALG.APV-527, development and continued development of Aptevo's current and potential future molecules, including its trispecific candidates, statements related to Aptevo's cash position and balance sheet, statements related to Aptevo's ability to generate stockholder value, whether Aptevo will continue to have momentum in its business in the future, statements regarding Aptevo's leadership transition, strategic direction, business outlook, expected future performance and any other statements containing the words "may," "continue to," "believes," "knows," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement.There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary or interim data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of mipletamig, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises, geopolitical risks, including the current war between Russia and Ukraine, the United States and Iran and any other military event that could evolve out of any of the current conflicts, and macroeconomic conditions such as economic uncertainty, imposition of tariffs, rising inflation and interest rates, continued market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances.CONTACT:Miriam Weber Miller
Vice President, Investor Relations & Corporate Communications
Aptevo Therapeutics
Email: IR@apvo.com or
US Market News
1月前
Aptevo Reports 87% Clinical Benefit and 81% Remission in 31 Evaluable Frontline AML Patients Through Cohort 5, Substantially Outperforming Benchmark; RAINIER on Track for 2026 Completion and Phase 2 Dose SelectionMay 6, 2026 8:05 AM
ACCESS NewswireProgram Enters Final Stage of Dose OptimizationData Continue to Demonstrate Strong Clinical Activity and Favorable Safety Across an Expanding Frontline DatasetSEATTLE, WA / ACCESS Newswire / May 6, 2026 / Aptevo Therapeutics Inc. (Nasdaq:APVO) today reported new clinical results from its RAINIER frontline acute myeloid leukemia (AML) trial. The Company is on track to complete the Phase 1b dose-optimization trial and select the recommended Phase 2 dose (RP2D) this year. As with the current study, the Phase 2 trial will dose mipletamig in combination with venetoclax and azacitidine.Across 31 evaluable frontline AML patients treated to date (includes data through RAINIER Cohort 5, plus 4 patients from the previously completed dose expansion trial), mipletamig in combination with venetoclax and azacitidine has demonstrated an 87% clinical benefit rate (CR/CRi/PR) and an 81% remission rate (CR/CRi), with results continuing to reflect a consistent profile of clinical activity and favorable safety as the dataset expands.With Cohort 5 complete, dosing has progressed through all previously evaluated mipletamig dose levels. The trial has now entered its final stage, which includes:Two final dose-level cohorts-Cohorts 6 and 7-representing the highest dose levels of mipletamig evaluated. Enrollment in Cohort 6 is nearing completionTwo groups of six additional patients will be enrolled at select dose levels, with the first enrolling concurrently with Cohort 6These activities will complete the dataset required for RP2D selection and the planned Phase 2 regulatory interaction, with the trial on track for completion this year."With the completion of Cohort 5, we have evaluated mipletamig across all previously studied dose levels and have entered the final stage of the RAINIER trial," said Jeff Lamothe, President and Chief Executive Officer of Aptevo Therapeutics. "The data is compelling, the remaining work is clearly defined, and the study is on track for completion this year, with the dataset enabling selection of the Phase 2 dose and our advancement into Phase 2. The strength and consistency of the data as it expands gives us confidence in the path forward."Among the evaluable frontline patient population treated to date (N=31), including 27 patients from the RAINIER trial through Cohort 5 and 4 patients from the completed dose-expansion trial, mipletamig in combination with venetoclax and azacitidine has demonstrated:87% clinical benefit rate,*demonstrating broad anti-leukemia activity and blast reduction across response categories81% achieved CR or CRi (remission), comparing favorably to the historical benchmark**.65% achieved CR (complete remission), comparing favorably to the historical benchmark**55% of patients who achieved CR/CRi had blast reductions that reached the important measurable residual disease-negative level, a result that is typically associated with stronger, more durable responses36% of patients with remissions had the TP53 genetic mutation, a high-risk biomarker typically associated with poor prognosis in AML and for which most treatment options frequently fail6 patients treated to date have proceeded to allogeneic stem cell transplant, which represents the best possible outcome in AML treatment and is rarely achieved in the older or unfit frontline patient populationNo cytokine release syndrome reported*Clinical benefit rate, including complete remission (CR), complete remission with incomplete hematologic recovery (CRi), and partial remission (PR)**In the Phase 3 VIALE-A trial evaluating venetoclax plus azacitidine in frontline intent-to-treat AML patients who were ineligible for intensive induction chemotherapy, the reported composite CR/CRi rate was 66.4%, and the CR rate was 37% (DiNardo et al., New England Journal of Medicine, 2020).Collectively, these data outperform the benchmark** and demonstrate mipletamig's potential to meaningfully enhance frontline AML treatment in older and/or unfit patients by improving efficacy outcomes without materially increasing toxicity."Our results demonstrate a consistent pattern of clinical activity and favorable safety across patients treated to date," said Dirk Huebner, M.D., Chief Medical Officer of Aptevo Therapeutics. "As dose selection progresses, the focus is on identifying a Phase 2 dose that is supported by a complete and well-characterized dataset."About the RAINIER TrialRAINIER, a frontline AML study, is a Phase 1b/2 dose-optimization, multi-center, multi-cohort, open-label study. Subjects are adults aged 18 or older, newly diagnosed with AML, who are not eligible for intensive induction chemotherapy. RAINIER will be conducted in two parts: first, a Phase 1b dose-optimization study in frontline AML patients, followed by a Phase 2 study. The Phase 1b trial consists of 28-day cycles of treatment across multiple sequential cohorts.About MipletamigAptevo's wholly owned lead proprietary drug candidate, mipletamig, being evaluated for the treatment of AML, is differentiated by design™ to redirect the immune system of the patient to destroy leukemic cells and leukemic stem cells expressing the target antigen CD123, which is a compelling target for AML due to its overexpression on leukemic stem cells and AML blasts. This antibody-like recombinant protein therapeutic is designed to engage both leukemic cells and T cells of the immune system and bring them closely together to trigger the destruction of leukemic cells.Mipletamig is purposefully designed to reduce the likelihood and severity of CRS by use of the CRIS-7-derived CD3 binding pathway, an approach that differentiates Aptevo from competitors. Mipletamig has received orphan drug designation ("orphan status") for AML under the Orphan Drug Act. Orphan drug designation provides key advantages-including the opportunity to seek U.S. market exclusivity for a specific period of time upon approval, FDA fee reductions, and access to development and tax credits. Mipletamig has been evaluated in more than 120 patients over three trials to date.About Aptevo TherapeuticsAptevo Therapeutics Inc. (Nasdaq: APVO) is a clinical-stage biotechnology company focused on developing novel bispecific and trispecific immunotherapies for the treatment of cancer. The Company has two clinical candidates and six preclinical candidates with different mechanisms of action designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIR and ADAPTIR-FLEX. Aptevo's mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit www.aptevotherapeutics.com.Safe Harbor StatementThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety, tolerability, and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for treatment of disease; its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms; statements related to the progress of Aptevo's clinical programs, including statements related to anticipated clinical and regulatory milestones; whether further study of mipletamig in a Phase 1b dose optimization trial focusing on multiple doses of mipletamig in combination with venetoclax and azacitidine on a targeted patient population will continue to show clinical benefit; whether further study of mipletamig in a Phase 1b dose-optimization trial will continue to report a favorable safety profile, let alone no instances of cytokine release syndrome, whether Aptevo's final trial results will vary from its earlier assessment; whether Aptevo's strategy will translate into an improved overall survival in AML, especially among patient subgroups with poor prognosis; whether further study of ALG.APV-527 across multiple tumor types will continue to show clinical benefit; the possibility and timing of interim data readouts for ALG.APV-527; statements related to Aptevo's ability to generate stockholder value; whether Aptevo will continue to have momentum in its business in the future; and any other statements containing the words "may," "continue to," "believes," "knows," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement.There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems; adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic, and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary or interim data and preclinical studies being predictive of the results of later-stage clinical trials; initiation, enrollment, and maintenance of patients; the completion of clinical trials; the availability and timing of data from ongoing clinical trials; the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of mipletamig; expectations for the timing and steps required in the regulatory review process; expectations for regulatory approvals; the impact of competitive products; our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all; and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business, or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; geopolitical risks, including the current war between Russia and Ukraine, the United States and Iran, and any other military event that could evolve out of any of the current conflicts; and macroeconomic conditions such as economic uncertainty, imposition of tariffs, rising inflation and interest rates, continued market volatility, and decreased consumer confidence. These risks are not exhaustive; Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances.CONTACT:
Miriam Weber Miller
Vice President, Investor Relations & Corporate Communications
Aptevo Therapeutics
Email: IR@apvo.com or
US Market News
3月前
Aptevo Provides State of the Business Report and 2025 Financial ResultsMarch 26, 2026 8:05 AM
ACCESS NewswireLatest mipletamig data delivers 86% clinical benefit rate with no cytokine release syndrome in 28 frontline AML patients, supporting its potential to enhance standard-of-care combination therapyCompany expands CD3 pipeline and introduces first trispecific drug candidatesSEATTLE, WA / ACCESS Newswire / March 26, 2026 / Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company developing novel immune-oncology therapeutics based on its proprietary ADAPTIR TM and ADAPTIR-FLEX TM platform technologies, today reported financial results for the year ended December 31, 2025 and provided a business update highlighting recent clinical progress, pipeline expansion and capital strategy."2025 was a year of meaningful progress across our clinical programs, pipeline strategy and capital position," said Marvin White, President and Chief Executive Officer of Aptevo Therapeutics. "Most importantly, recently reported mipletamig data continue to demonstrate encouraging remission outcomes together with a favorable safety profile, including no cytokine release syndrome observed in frontline patients treated to date. These results support the potential for mipletamig to enhance frontline AML treatment alongside existing standard-of-care therapy."White continued, "During the year we also expanded our CD3 pipeline, introduced our first trispecific programs and strengthened our access to capital to support continued execution. As I transition into the role of Executive Chair and Jeff Lamothe assumes the responsibilities of President and Chief Executive Officer, I am confident in the Company's ability to build on this momentum."HighlightsAptevo entered 2026 with momentum:Mipletamig Clinical Performance: Mipletamig in triplet combination therapy continues to outperform standard of care ven/aza 1 in unfit frontline patients with acute myeloid leukemia (AML). This further validates a differentiated safety profile, including no cytokine release syndrome in frontline patients, suggesting it is additive to the current standard of careExpanded CD3 portfolio: the addition of three new multispecific candidates, leveraging the Company's proprietary application of its differentiated CRIS7-derived CD3 binding domain, including the introduction of its first two trispecific assetsThese additions emphasize the breadth and modularity of the ADAPTIR and ADAPTIR-FLEX platforms and position the Company to address a wider range of tumor targets and combination strategies across immune-oncologyStrengthened Financial Capacity: In 2026, the Company established a $60 million equity line facility, providing additional access to capital, subject to market conditions and the Company's capital deployment strategy. If fully utilized, this facility, together with current resources, is expected to support operations into 2029.Encouraging Frontline AML DataUpdated interim results from 28 evaluable frontline AML patients 2 treated with mipletamig in combination with ven/aza demonstrate an emerging clinical profile that is additive in combination with standard of care. The triplet regimen delivered an 86% clinical benefit rate, including a 79% CR/CRi (vs. 66% ) 1 remission rate and a 61% complete remission rate (vs.37%) 1.Among patients achieving remission, 55% reached measurable residual disease-negative status. Notably, 35% of remissions occurred in patients with TP53 mutations, a high-risk biomarker typically associated with poor prognosis.Importantly, no cytokine release syndrome has been observed in frontline patients treated to date. Outcomes from the mipletamig triplet compare favorably with historical results reported for the ven/aza doublet and support the potential for mipletamig to enhance frontline AML therapy for older and/or unfit patients."Mipletamig continues to demonstrate encouraging remission outcomes together with a consistently favorable safety profile," said Dirk Huebner, M.D., Chief Medical Officer of Aptevo Therapeutics. "The absence of cytokine release syndrome in frontline patients underscores the potential advantage of our differentiated CD3 design in combination treatment settings."Huebner added, "Four patients treated to date have proceeded to allogeneic stem cell transplant, representing the most favorable treatment outcome in AML and an uncommon achievement in the older and/or unfit frontline population."A Differentiated CD3 PlatformDuring 2025 Aptevo expanded its CD3 portfolio with three new multispecific candidates, including the Company's first two trispecific drug candidates designed to address complex solid tumor microenvironments.All programs leverage Aptevo's proprietary CRIS-7-derived CD3 binding domain, designed to promote targeted T-cell activation while reducing systemic immune overstimulation. Clinical experience with mipletamig, now evaluated in more than 120 patients across three trials, provides early validation of this design approach.The Company now has a five-molecule CD3 portfolio spanning hematologic malignancies and solid tumors, including programs targeting AML, prostate cancer and Nectin-4-expressing tumors.Capital Strategy and Financial FlexibilityAptevo ended 2025 with $21.6 million in cash and cash equivalents, compared with $8.7 million at December 31, 2024, and expects current resources to support operations into the fourth quarter of 2026.In 2026, the Company also established a $60 million equity line with Yorkville Advisors Global, LP. The equity line provides financing flexibility and allows Aptevo to access capital opportunistically based on its needs and market conditions. The Company is not required to utilize the full capacity of the facility and continues to evaluate additional strategic and non-dilutive funding opportunities.1 DiNardo et al. N Engl J Med 2020;383:617-29
2 Total frontline patients include 4 from the completed dose escalation trial and 24 from the ongoing RAINIER dose optimization trial2025 Summary Financial ResultsCash Position: Aptevo had cash and cash equivalents as of December 31, 2025, totaling $21.6 million.Research and Development Expenses: Research and development expenses was $14.5 million and $14.4 million for the years ended December 31, 2025, and 2024, respectively. The increase was primarily due to increased mipletamig and employee costs and was offset by lower costs on ALG.APV- 527 as we concluded the dose escalation trial.General and Administrative Expenses: General and administrative expenses increased by $1.6 million, to $11.8 million for the year ended December 31, 2025, from $10.2 million for the year ended December 31, 2024. The increase is primarily due to higher employee, consulting, and legal costs.Other Income Net: Other Income, net was $0.3 million for the year ended December 31, 2025, and other income, net was $0.5 million for the year ended December 31, 2024. The change was primarily due to lower interest and rental income.Net Loss Attributable to Common Shareholders: For the years ended December 31, 2025, and 2024, Aptevo had a net loss of $26.0 million and $24.1 million, respectively. The Company recorded a dividend deemed attributable to down round feature of common warrants of $1.6 million in 2025. The basic and diluted net loss per share for the year ended December 31, 2025, was $87.27 per share, compared to $31,460.23 per share for the corresponding period in 2024.Dividend Attributable to Down Round Feature of Warrants: This non-cash amount reflects the impact of reducing the exercise price of the Company's June 2025 warrants from the original $58.50 per share to $19.01 per share, the lowest price at which we sold common shares after issuance of such common warrants due to contractual requirements of the warrants. The exercise price was further adjusted to the floor price of $11.70 as a result of additional shares of common stock sold in January 2026. The $1.6 million recorded in the year ended December 31, 2025, reflects dividend deemed to common shareholders and it increases net loss attributable to common shareholders to $27.5 million for EPS purposes.
Aptevo Therapeutics Inc.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts) December 31, 2025 December 31, 2024 ASSETS Current assets: Cash and cash equivalents $21,619 $8,714 Prepaid expenses and other current assets 1,462 1,945 Total current assets 23,081 10,659 Property and equipment, net 303 543 Operating lease right-of-use asset 3,810 4,389 Total assets $27,194 $15,591 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $877 $1,242 Accrued expenses and other current liabilities 4,307 4,197 Operating lease liability, current portion 866 768 Total current liabilities 6,050 6,207 Operating lease liability, net of current portion 3,763 4,629 Total liabilities 9,813 10,836 Stockholders' equity: Preferred stock: $0.001 par value; 15,000,000 shares authorized, zero shares
issued or outstanding - - Common stock: $0.001 par value; 500,000,000 shares authorized; 997,830
and 4,051 shares issued and outstanding at December 31, 2025 and
December 31, 2024, respectively 114 84 Additional paid-in capital 292,382 252,248 Accumulated deficit (275,115) (247,577)Total stockholders' equity 17,381 4,755 Total liabilities and stockholders' equity $27,194 $15,591 Aptevo Therapeutics Inc.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts) For the Year Ended December 31, 2025 2024 Operating expenses: Research and development $(14,540) $(14,378)General and administrative (11,772) (10,224)Loss from operations (26,312) (24,602)Other income: Other income, net 345 472 Net loss $(25,967) $(24,130)Dividend attributable to down round feature of warrants (1,571) - Net loss attributable to common stockholders $(27,538) $(24,130) Basic and diluted net loss per share: $(87.27) $(31,460.23) Shares used in calculation: 315,535 767 About Aptevo TherapeuticsAptevo Therapeutics Inc. (Nasdaq:APVO) is a clinical-stage biotechnology company focused on developing novel bispecific and trispecific immunotherapies for the treatment of cancer. The Company has two clinical candidates. Mipletamig is currently being evaluated in RAINIER, a two-part Phase 1b/2 trial for the treatment of frontline acute myeloid leukemia in combination with standard-of-care venetoclax + azacitidine. Mipletamig has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act. ALG.APV-527, a bispecific conditional 4-1BB agonist, designed to only be active upon simultaneous binding to 4-1BB and 5T4, is being co-developed with Alligator Bioscience and was most recently evaluated in a Phase 1 clinical trial for the treatment of multiple solid tumor types likely to express 5T4. The Company has six preclinical candidates with different mechanisms of action designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIRand ADAPTIR-FLEX. The Aptevo mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit www.aptevotherapeutics.com.Safe Harbor StatementThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety, tolerability and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for treatment of disease, its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, statements related to the progress of Aptevo's clinical programs, including statements related to anticipated clinical and regulatory milestones, whether further study of mipletamig in a Phase 1b dose optimization trial focusing on multiple doses of mipletamig in combination with venetoclax + azacitidine on a targeted patient population will continue to show remissions, let alone at a rate of 100%, whether Aptevo's final trial results will vary from its earlier assessment, whether Aptevo's strategy will translate into an improved overall survival in AML, especially among patient subgroups with poor prognosis, whether further study of ALG.APV-527 across multiple tumor types will continue to show clinical benefit, the possibility and timing of interim data readouts for ALG.APV-527, development and continued development of Aptevo's current and potential future molecules, including the Company's trispecific candidates and their future development and efficacy with respect to addressing multiple solid tumor types, whether pre-clinical studies of Aptevo's trispecific candidates will show the desired anti-tumor efficacy, mechanism of action and safety profile and whether Aptevo's trispecific candidates will function with new mechanisms of action compared to our previous candidates and synergistically induce a biological response, statements related to Aptevo's cash position and balance sheet, statements related to Aptevo's ability to access capital and funding runway, statements related to Aptevo's ability to generate stockholder value, whether Aptevo will continue to have momentum in its business in the future, and any other statements containing the words "may," "continue to," "believes," "knows," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement.There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary or interim data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of mipletamig, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises , geopolitical risks, including the current war between Russia and Ukraine, the war between United States and Iran and any other military event that could evolve out of any of the current conflicts, and macroeconomic conditions such as economic uncertainty, imposition of tariffs, rising inflation and interest rates, continued market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances.CONTACT:Miriam Weber Miller
VP, Investor Relations & Corporate Communications
Aptevo Therapeutics
Email: IR@apvo.com or
US Market News
3月前
Aptevo to Participate in March 2026 ConferencesMarch 19, 2026 8:05 AM
ACCESS NewswireSEATTLE, WA / ACCESS Newswire / March 19, 2026 / Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company developing novel immune-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, today announced its participation in the following March conferences:The 38th Annual Roth Conference
March 22-24, 2026, in Dana Point, CA. Aptevo incoming President and Chief Executive Officer Jeff Lamothe will participate in a Company-focused fireside chat with analyst Jonathan Aschoff. The discussion will occur on Monday, March 23, 2026, at 1:30 PM Pacific Time, and will be broadcast live at the conference.The Roth conference will consist of 1-on-1 and small group meetings, analyst-selected fireside chats, industry keynotes, and panels with executive management attending from hundreds of private and public companies across a variety of growth sectors.BIO-Europe Spring
March 23-25, 2026, in Lisbon, Portugal. Aptevo will deliver a company presentation highlighting its proprietary trispecific molecules developed from the Company's ADAPTIR-FLEX platform. Michelle H. Nelson, PhD, Senior Director, Immunobiology, will present on Tuesday, March 24, 2026, at 1:15 PM Eastern Time (5:15 PM Central European Time).BIO-Europe Spring is one of the premier partnering events for the life sciences industry, bringing together biotechnology and pharmaceutical companies, investors, and strategic partners to explore collaboration and licensing opportunities.About Aptevo Therapeutics
Aptevo Therapeutics Inc. (NASDAQ:APVO) is a clinical-stage biotechnology company focused on developing novel bispecific and trispecific immunotherapies for the treatment of cancer. The Company has two clinical candidates and six preclinical candidates with different mechanisms of action designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIR and ADAPTIR-FLEX. The Aptevo mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit www.aptevotherapeutics.com.Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety, tolerability and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for treatment of disease, its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, statements related to the progress of Aptevo's clinical programs, including statements related to anticipated clinical and regulatory milestones, whether further study of mipletamig in a Phase 1b dose optimization trial focusing on multiple doses of mipletamig in combination with venetoclax and azacitidine on a targeted patient population will continue to show remissions, whether Aptevo's final trial results will vary from its earlier assessment, whether Aptevo's strategy will translate into an improved overall survival in AML, especially among patient subgroups with poor prognosis, whether further study of ALG.APV-527 across multiple tumor types will continue to show clinical benefit, the possibility and timing of interim data readouts for ALG.APV-527, statements related to Aptevo's ability to generate stockholder value, whether Aptevo will continue to have momentum in its business in the future, and any other statements containing the words "may," "continue to," "believes," "knows," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement.There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary or interim data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of mipletamig, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises, geopolitical risks, including the current war between Russia and Ukraine, the United States and Iran, and any other military event that could evolve out of any of the current conflicts, and macroeconomic conditions such as economic uncertainty, imposition of tariffs, rising inflation and interest rates, continued market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances.CONTACT:
Miriam Weber Miller
Vice President, Investor Relations & Corporate Communications
Aptevo Therapeutics
Email: IR@apvo.com or
US Market News
3月前
Mipletamig Delivers Compelling 86% Clinical Benefit Rate and No CRS as Evaluable AML Patient Data increases by Nearly 50%March 10, 2026 8:05 AM
ACCESS NewswireFrontline patient outcomes are making the case for mipletamig to enhance standard-of-care therapy alongside venetoclax + azacitidineSEATTLE, WA / ACCESS Newswire / March 10, 2026 / Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company developing novel immune-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, today announced new interim data for mipletamig in combination with venetoclax and azacitidine in newly diagnosed acute myeloid leukemia (AML) patients who are either elderly or unfit for intensive chemotherapy. In data from two trials, the combination has demonstrated robust clinical activity, delivering an 86% clinical benefit rate (CR/CRi/PR*)with zero patients experiencing the common symptom of cytokine release syndrome (CRS). These data support an emerging efficacy profile coupled with differentiated patient safety and tolerability that is additive to the current AML standard-of-care therapy."The emerging mipletamig data in frontline AML are highly encouraging and highlight the differentiated profile we believe is needed to advance treatment in frontline AML," said Dirk Huebner, M.D., Chief Medical Officer of Aptevo Therapeutics. "In this study we are observing strong remission rates in a growing number of evaluable patients together with a consistently favorable safety and tolerability profile, including the absence of cytokine release syndrome. Achieving meaningful clinical activity while maintaining this level of safety and tolerability is essential in the frontline AML setting, where therapies must be compatible with established regimens. These results reinforce our belief that mipletamig can be successfully combined with venetoclax and azacitidine, with the potential to enhance outcomes for older and/or unfit AML patients who continue to face poor prognosis and limited treatment options."Huebner continued, "Importantly, four of the patients treated to date have proceeded to allogeneic stem cell transplant, which represents the best possible outcome in AML treatment and is rarely achieved in the older or unfit frontline patient population."Data Highlights Include:Among the evaluable frontline patient population treated to date (N=28), including 24 patients from the RAINIER trial and 4 patients from the completed dose expansion trial, mipletamig in combination with venetoclax and azacitidine has demonstrated:100% of frontline patients have remained free of cytokine release syndrome (CRS)86% clinical benefit rate79% achieved CR or CRi61% achieved CR55% of patients who achieved CR/CRi had blast reductions that reached the important measurable residual disease-negative level, a result that is typically associated with stronger, more durable responses35% of patients with remissions had the TP53 genetic mutation, a high-risk biomarker typically associated with poor prognosis in AML and for which most treatment options frequently failCollectively, these data demonstrate mipletamig's potential to meaningfully enhance frontline AML treatment in older and/or unfit patients, by improving efficacy outcomes without materially increasing toxicity."Our frontline data show that mipletamig has the potential to play a meaningful role in the future frontline AML treatment," said Marvin White, President and Chief Executive Officer of Aptevo Therapeutics. "From the outset, our objective has been to develop an AML drug capable of integrating into the current standard-of-care and improving outcomes for patients who continue to face poor prognoses. The data reported reinforces our conviction that mipletamig may represent a differentiated approach with the potential to complement existing frontline therapies in a practical and impactful way. As enrollment continues, we remain focused on advancing our RAINIER trial and generating the data needed to support mipletamig's long-term role in AML treatment."*(Clinical Benefit Rate: CR = complete remission; CRi = complete remission with incomplete blood marker recovery; PR = partial remission.)Consistent Safety and Tolerability Profile Maintained Across Patients Treated to DateIn frontline patients treated to date, no cytokine release syndrome (CRS) has been observed. Together with strong efficacy outcomes, this outcome underscores mipletamig's safety and combinability, potentially offering a superior treatment in the future. This safety profile is particularly important in frontline AML, where tolerability and combinability are essential for treating older patients and/or those with comorbidities.About the RAINIER TrialRAINIER, a frontline AML study, is a Phase 1b/2 dose optimization, multi-center, multi-cohort, open label study. Subjects are adults aged 18 or older, newly diagnosed with AML who are not eligible for intensive induction chemotherapy. RAINIER will be conducted in two parts. First, a Phase 1b dose optimization study in frontline AML patients followed by a Phase 2 study. The Phase 1b trial consists of 28-day cycles of treatment across multiple, sequential cohorts.About MipletamigAptevo's wholly owned lead proprietary drug candidate, mipletamig, being evaluated for the treatment of AML, is differentiated by design™ to redirect the immune system of the patient to destroy leukemic cells and leukemic stem cells expressing the target antigen CD123, which is a compelling target for AML due to its overexpression on leukemic stem cells and AML blasts. This antibody-like recombinant protein therapeutic is designed to engage both leukemic cells and T cells of the immune system and bring them closely together to trigger the destruction of leukemic cells. Mipletamig is purposefully designed to reduce the likelihood and severity of CRS by use of the CRIS-7-derived CD3 binding pathway, an approach that differentiates Aptevo from competitors. Mipletamig has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act. Orphan drug designation provides key advantages-including the opportunity to seek U.S. market exclusivity for a specific period of time upon approval, FDA fee reductions, and access to development and tax credits. Mipletamig has been evaluated in more than 120 patients over three trials to date.About Aptevo TherapeuticsAptevo Therapeutics Inc. (Nasdaq:APVO) is a clinical-stage biotechnology company focused on developing novel bispecific and trispecific immunotherapies for the treatment of cancer. The Company has two clinical candidates and six preclinical candidates with different mechanisms of action designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIRand ADAPTIR-FLEX. The Aptevo mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit www.aptevotherapeutics.com.Safe Harbor StatementThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety, tolerability and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for treatment of disease, its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, statements related to the progress of Aptevo's clinical programs, including statements related to anticipated clinical and regulatory milestones, whether further study of mipletamig in a Phase 1b dose optimization trial focusing on multiple doses of mipletamig in combination with venetoclax and azacitidine on a targeted patient population will continue to show remissions, whether Aptevo's final trial results will vary from its earlier assessment, whether Aptevo's strategy will translate into an improved overall survival in AML, especially among patient subgroups with poor prognosis, whether further study of ALG.APV-527 across multiple tumor types will continue to show clinical benefit, the possibility and timing of interim data readouts for ALG.APV-527, statements related to Aptevo's ability to generate stockholder value, whether Aptevo will continue to have momentum in its business in the future, and any other statements containing the words "may," "continue to," "believes," "knows," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement.There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary or interim data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of mipletamig, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises, geopolitical risks, including the current war between Russia and Ukraine, the United States and Iran, and any other military event that could evolve out of any of the current conflicts, and macroeconomic conditions such as economic uncertainty, imposition of tariffs, rising inflation and interest rates, continued market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances.CONTACT:
Miriam Weber Miller
Vice President, Investor Relations & Corporate Communications
Aptevo Therapeutics
Email: IR@apvo.com or
US Market News
4月前
Aptevo Announces Executive Leadership Transitions to Support Next Phase of GrowthFebruary 3, 2026 8:05 AM
ACCESS NewswireClinical progress, pipeline expansion, and operational momentum underpin leadership continuity as the Company advances into 2026 and beyondSEATTLE, WA / ACCESS Newswire / February 3, 2026 / Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company developing novel immune-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, today announced executive leadership transitions to support the Company's continued execution, drive achievement of long-term strategic objectives, and next phase of growth.Effective April 1, 2026, Marvin White, who has served as President and Chief Executive Officer since 2016, has chosen to retire from this position and assume the role of Executive Chair, where he will focus on cultivating strategic opportunities to help shape long-term success. Jeff Lamothe, currently Chief Operating Officer, will assume the role of President and Chief Executive Officer and will join Aptevo's Board of Directors. John E. Niederhuber, M.D., will transition from Chairman of the Board to Lead Independent Director. All three leaders have been part of Aptevo since the Company's inception in 2016, and the leadership changes reinforce continuity while supporting the Company's continued execution and future success."Aptevo has reached an important inflection point," said Mr. White. "We have a clinically proven platform, a growing body of patient data, a strong balance sheet, access to liquidity sources, and a leadership team that has been executing together for many years. I am not stepping away from the Company; rather, this transition reflects a purposeful shift in how we are aligned as a leadership team. With Jeff serving as President and CEO, I will be able to devote more time serving the Company by identifying and advancing strategic growth opportunities."Under the leadership of Mr. White and Mr. Lamothe, Aptevo has evolved into a company with a clinically validated platform, an expanded and diversified pipeline, and a strong financial foundation. During their tenure, the Company established proof-of-concept for its proprietary technology, introduced ADAPTIR-FLEX™ as a second platform that complements ADAPTIR™, and built a pipeline of eight molecules. Aptevo also broadened its therapeutic scope beyond bispecific antibodies to include two trispecific programs, while creating and executing a strategy to leverage its proprietary and differentiated CD3 binding domain. We believe these advances have translated into meaningful clinical outcomes, enabling many patients enrolled in Aptevo's clinical trials to achieve complete remission. More than 100 patients have now been treated with the Company's CD123 x CD3 program, mipletamig, which has demonstrated consistent signals of strong efficacy alongside a differentiated safety profile in acute myeloid leukemia. In parallel, Aptevo has expanded its pipeline through both internal development and external collaboration, including its partnership with Alligator Bioscience for the development of ALG.APV-527 in solid tumors.At the same time, Aptevo has strengthened its financial position, establishing a cash runway into 2029, including capital available under the recently announced $60 million equity line of credit. Collectively, these accomplishments reflect disciplined execution across technology development, clinical advancement, pipeline expansion, and financial stewardship."I want to thank John for his leadership as Chairman and for the thoughtful, steady guidance he has provided to Aptevo over the years. I am grateful that he will continue to serve the Company as Lead Independent Director, and I value his continued partnership," said Mr. White.He continued, "Jeff has been a driving force behind many of the Company's most important advances, and both the Board and I have complete confidence in his leadership. He is the right leader to guide Aptevo forward at this stage, and I am excited to continue working closely with him as Executive Chair as we focus on advancing our strategy, expanding partnerships, and building on the momentum we have created."Mr. White's move to Executive Chair will deepen Aptevo's focus on harnessing strategic opportunities that align with corporate growth goals and maintaining continuity at the leadership level. As Executive Chair, he will also serve as a strategic advisor, leveraging his experience to help guide Aptevo's next stage of growth.Mr. Lamothe's appointment reflects his central role in Aptevo's accomplishments and his leadership across day-to-day operations and vision for growth. Many of the Company's key advances-including clinical progress, pipeline development, operational discipline, and financial execution-have occurred under his direct leadership as Chief Operating Officer, in close partnership with Mr. White."Jeff has been instrumental in building the operational foundation we have today," Mr. White added. "He understands this organization deeply, has earned the confidence of the Board, and is the right leader to carry Aptevo forward as we execute against our goals.""I am honored to step into the role of President and CEO at this stage of Aptevo's journey," said Mr. Lamothe. "We have a strong team, a clear plan, and a pipeline we believe has the meaningful potential to positively impact the lives of patients fighting cancer. Our focus remains on disciplined execution - completing the mipletamig Phase 1b program, advancing our pipeline, and pursuing business development opportunities that align with our strategy and capabilities."In his most recent role as Chief Operating Officer, Mr. Lamothe oversaw Clinical, Research and Development, Quality, Manufacturing, and Operations, strengthening execution across the organization while advancing Aptevo's programs. Previously, as Chief Financial Officer, he led Finance, Business Development, Investor Relations, and Information Technology, providing broad strategic and operational perspective."It has been a privilege to serve as Chairman of Aptevo's Board," said Dr. Niederhuber. "As Lead Independent Director, I look forward to continuing to support the Company and working closely with Marvin and Jeff as Aptevo builds on its progress and pursues its next chapter."With a proven platform, advancing clinical programs, and a leadership structure aligned to support both execution and long-term strategy, we believe Aptevo is well positioned to continue progressing toward its objectives and delivering meaningful impact for patients fighting many different types of cancer.About Aptevo Therapeutics
Aptevo Therapeutics Inc. (Nasdaq: APVO) is a clinical-stage biotechnology company focused on developing novel multispecifics immunotherapies for the treatment of cancer. The Company has two clinical candidates. Mipletamig is currently being evaluated in RAINIER, a two-part Phase 1b/2 trial for the treatment of frontline acute myeloid leukemia in combination with standard-of-care venetoclax + azacitidine. Mipletamig has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act. ALG.APV-527, a bispecific conditional 4-1BB agonist, designed to only be active upon simultaneous binding to 4-1BB and 5T4, is being co-developed with Alligator Bioscience and was most recently evaluated in a Phase 1 clinical trial for the treatment of multiple solid tumor types likely to express 5T4. The Company has six preclinical candidates with different mechanisms of action designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIR™and ADAPTIR-FLEX™. The Aptevo mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit www.aptevotherapeutics.com.Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety, tolerability and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for treatment of disease, its expectations regarding the effectiveness of its ADAPTIR™ and ADAPTIR-FLEX™ platforms, statements related to the progress of Aptevo's clinical programs, including statements related to anticipated clinical and regulatory milestones, whether further study of mipletamig in a Phase 1b dose optimization trial focusing on multiple doses of mipletamig in combination with venetoclax + azacitidine on a targeted patient population will continue to show remissions, whether Aptevo's final trial results will vary from its earlier assessment, whether Aptevo's strategy will translate into an improved overall survival in AML, especially among patient subgroups with poor prognosis, whether further study of ALG.APV-527 across multiple tumor types will continue to show clinical benefit, the possibility and timing of interim data readouts for ALG.APV-527, development and continued development of Aptevo's current and potential future molecules, statements related to Aptevo's cash position and balance sheet, statements related to Aptevo's ability to access to capital and funding runway, statements related to Aptevo's ability to generate stockholder value, whether Aptevo will continue to have momentum in its business in the future, statements regarding the Company's leadership transition, strategic direction, business outlook, expected future performance and any other statements containing the words "may," "continue to," "believes," "knows," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement.There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, a deterioration in Aptevo's business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary or interim data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of mipletamig, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises, geopolitical risks, including the current war between Russia and Ukraine and any other military event that could evolve out of any of the current conflicts, and macroeconomic conditions such as economic uncertainty, imposition of tariffs, rising inflation and interest rates, continued market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances.CONTACT:
Miriam Weber Miller
Head, Investor Relations & Corporate Communications
Aptevo Therapeutics
Email: IR@apvo.com or
MartinLutherKing
1年前
With this magnitude news you would suppose to be celebrating
100% of Patients Achieve Remission Within 30 Days in Cohort 1 of Bispecific Mipletamig Frontline AML Trial
Two of three patients achieved both complete remission and MRD-negative status
High response rates observed in earlier studies continue in ongoing mipletamig trial
Cohort 2 enrollment commencing
SEATTLE, WA / ACCESSWIRE / December 12, 2024 / Aptevo Therapeutics ("Aptevo") (Nasdaq:APVO), a clinical-stage biotechnology company focused on developing novel bispecific immune-oncology therapeutics based on its proprietary ADAPTIR® and ADAPTIR-FLEX® platform technologies, today announced 100% of patients achieved remission* within 30 days, in Cohort 1 of the RAINIER frontline acute myeloid leukemia (AML) Phase 1b trial, including two patients who experienced complete remission with minimal residual disease (MRD)-negative status (100% elimination of cancer cells). The results build on data from the prior trial, in which 100% of frontline patients also achieved remission. *(Remission = complete remission (CR) and, complete remission with blood markers that have not yet recovered (CRi).
"We are very excited by these Cohort 1 results as they add to an already compelling story that highlights mipletamig's potential to elevate the frontline AML treatment paradigm. We now have a 100% rate of remission in Cohort 1 of RAINIER. We saw a 100% rate of remission in frontline patients treated with the combination in our completed dose expansion trial. Remarkably, 86% of patients across both trials went into remission within 30 days of receiving their first treatment," said Marvin White, President and CEO of Aptevo. "It's also important to note that mipletamig continues to demonstrate a favorable safety and tolerability profile, reinforcing its potential as a transformative addition to the standard of care combination. Cohort 2 enrollment is commencing, marking the next step in the study. We look forward to sharing new results as they become available."
Mipletamig, a CD3 x CD123 bispecific antibody, is being investigated as frontline therapy in combination with venetoclax and azacitidine, a current standard of care for AML. These latest results further reinforce mipletamig's potential as a transformative treatment, supported by impressive efficacy, safety, and tolerability data from two prior clinical trials involving 90 patients.
"Achieving remission in all three Cohort 1 patients is highly encouraging, particularly when viewed alongside prior trial results. Notably, two of these three patients achieved MRD-negative status, a critical outcome indicating that even the most sensitive diagnostic methods detect no remaining cancer cells. This result is strongly associated with longer-lasting remissions and improved survival rates," said Dirk Huebner, MD, Chief Medical Officer at Aptevo. "What makes these outcomes even more compelling is that one of the MRD-negative patients had a TP53 mutation, a subgroup known for its poor prognosis due to chemotherapy resistance, genetic instability, and overall treatment challenges. This growing body of data underscores mipletamig's potential to address some of the most difficult hurdles in AML treatment, delivering deep and durable responses for patients with the greatest need."
About RAINIER
RAINIER, a frontline AML study, is a Phase 1b/2 dose optimization, multi-center, multi-cohort, open label study of up to 39 patients who are being treated across five dose levels ranging from 9 mcg - 140 mcg in combination with venetoclax and azacitidine (ven/aza). Subjects will be adults aged 18 or older, newly diagnosed with AML who are not eligible for intensive induction chemotherapy. Phase 1b consists of 28-day cycles of treatment in five sequential cohorts. Aptevo has partnered with Prometrika (https://www.prometrika.com/), a premier contract research organization for the trial. RAINIER will be conducted in two parts. First, a Phase 1b dose optimization study in frontline AML patients followed by a Phase 2 study.
About Mipletamig
Aptevo's wholly owned lead proprietary drug candidate, mipletamig, targeting AML, MDS and other leukemias, is differentiated by design to redirect the immune system of the patient to destroy leukemic cells and leukemic stem cells expressing the target antigen CD123, which is a compelling target for AML due to its overexpression on leukemic stem cells and AML blasts. This antibody-like recombinant protein therapeutic is designed to engage both leukemic cells and T cells of the immune system and bring them closely together to trigger the destruction of leukemic cells. Mipletamig is purposefully designed to reduce the likelihood and severity of CRS by use of a unique CD3 derived from CRIS-7 vs. the CD3 used by other competitors. Mipletamig has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act. Mipletamig has been evaluated in 90 patients over two trials to date. RAINIER, Aptevo's Phase 1b/2 frontline AML program, was initiated in 3Q24.
About Aptevo Therapeutics
Aptevo Therapeutics Inc. (Nasdaq:APVO) is a clinical-stage biotechnology company focused on developing novel bispecific immunotherapies for the treatment of cancer. The company has two clinical candidates. Mipletamig is currently being evaluated in RAINIER, a Phase 1b/2 trial for the treatment of frontline acute myeloid leukemia in combination with standard of care venetoclax + azacitidine. Mipletamig has orphan status for AML according to the Orphan Drug Act. ALG.APV-527, a bispecific conditional 4-1BB agonist that is only active upon simultaneous binding to 4-1BB and 5T4, is being co-developed with Alligator Bioscience and is being evaluated in a Phase 1 clinical trial for the treatment of multiple solid tumor types likely to express 5T4. Aptevo has three pre-clinical candidates with different mechanisms of action designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIR® and ADAPTIR-FLEX®. The Aptevo mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit www.aptevotherapeutics.com.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety, tolerability and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for treatment of disease, its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, statements related to the progress of Aptevo's clinical programs, including statements related to anticipated clinical and regulatory milestones, whether further study of mipletamig in a Phase 1b dose optimization trial focusing on multiple doses of mipletamig in combination with venetoclax + azacitidine on a targeted patient population will continue to show remissions, let alone at a rate of 100%, whether Aptevo's final remission data or trial results will vary from its earlier assessment, whether Aptevo's strategy will translate into an improved overall survival in AML, especially among patient subgroups with poor prognosis, whether further study of ALG.APV-527 across multiple tumor types will continue to show clinical benefit, the possibility and timing of future preliminary or interim data readouts for ALG.APV-527, statements related to the progress of and enthusiasm for Aptevo's clinical programs, statements related to Aptevo's ability to generate stockholder value, whether Aptevo will continue to have momentum in its business in the future, and any other statements containing the words "may," "continue to," "believes," "knows," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement.
There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary or interim data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of mipletamig, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the coronavirus (referred to as COVID-19), geopolitical risks, including the current war between Russia and Ukraine, war between Israel and Hamas, and macroeconomic conditions such as economic uncertainty, rising inflation and interest rates, continued market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances.