iHub News
4週前
Purple Biotech Presents New IM1240 Preclinical Data Showing Anti-Tumor Activity and Broad Therapeutic Window (PPBT)June 11, 2026 10:38 AM
IH Market News New data presented at EACR 2026 highlighted anti-tumor activity, improved safety characteristics, and pharmacokinetic advantages for Purple Biotech’s lead immunotherapy candidate as it advances toward human testing. Key Investor Takeaways Purple Biotech (NASDAQ:PPBT) reported new preclinical IM1240 data supporting advancement into a planned first-in-human study in 2027. The CAPTN-3 immunotherapy platform demonstrated anti-tumor activity in multiple treatment-resistant cancer models. IM1240 showed an approximately eight-fold longer half-life and sixteen-fold greater systemic exposure than an earlier non-capped variant. Safety findings suggest the platform’s masking strategy may reduce cytokine release syndrome risk, a key challenge for T-cell engager therapies. The program remains preclinical, making future clinical development and regulatory progress critical catalysts for investors. Why PPBT Stock Is In Focus Purple Biotech presented new preclinical findings for IM1240, the lead candidate from its CAPTN-3 platform, at the European Association for Cancer Research (EACR) 2026 Congress. The data included evidence of anti-tumor activity in patient-derived tumor samples from multiple difficult-to-treat cancers, including PD-1-resistant head and neck squamous cell carcinoma, non-small cell lung cancer (NSCLC), and bladder cancer. According to the company, IM1240 induced cancer cell apoptosis in several resistant tumor samples and demonstrated immune system activation that was dependent on both its CD3 and NKG2A targeting mechanisms. The company also reported favorable pharmacokinetic and safety results from a non-GLP toxicology study in non-human primates. IM1240 achieved approximately eight times the half-life and sixteen times the systemic exposure of its non-capped predecessor, IM1222. Importantly, Purple Biotech stated that the CAPTN-3 masking strategy substantially reduced peripheral immune activation and cytokine release, two factors often associated with safety challenges in T-cell engager therapies. Why This Matters for Investors For early-stage biotechnology companies, preclinical data can help establish whether a therapy has a realistic pathway toward clinical development. The latest results are notable because they address two key areas that investors often monitor in immunotherapy programs: efficacy and safety. The anti-tumor activity observed across treatment-resistant cancer models may support the company’s argument that IM1240 could have utility in patients who have exhausted existing treatment options. At the same time, the reported pharmacokinetic improvements and broader therapeutic window may help differentiate the CAPTN-3 platform from other immune-engaging therapies that can face dose-limiting toxicity issues. The data also reinforce Purple Biotech’s strategy of combining T-cell and natural killer (NK) cell engagement while attempting to confine immune activation primarily to the tumor microenvironment. However, investors should note that the program remains in the preclinical stage. While the results may strengthen confidence in the development strategy, the ultimate value of the platform will depend on whether these findings translate into successful human clinical outcomes. What To Watch Next Several milestones could shape investor sentiment toward the program: Advancement of IM1240 into a first-in-human clinical study planned for 2027. Additional preclinical data supporting the CAPTN-3 platform. Regulatory interactions as the company prepares for clinical development. Updates on IM1305, the platform’s second preclinical candidate. Potential partnership, licensing, or financing developments related to the broader oncology pipeline. For now, the key takeaway is that Purple Biotech has generated new preclinical evidence supporting both the efficacy and safety profile of IM1240 as it moves closer to entering the clinic. Purple Biotech stock price Original: Purple Biotech Presents New IM1240 Preclinical Data Showing Anti-Tumor Activity and Broad Therapeutic Window (PPBT)
INV4
8月前
Cancer Immunotherapy Innovators Break New Ground in Antibody Engineering
Oct 29, 2025
As the biotech sector continues to evolve, breakthroughs in antibody technology are reshaping the landscape of cancer treatment. With the global oncology market projected to exceed $500 billion by 2030, developers at the cutting edge of immune modulation are racing to design therapies that not only attack tumors but also enhance the body’s own defense systems. Among the most promising approaches are tri-specific antibodies—complex, next-generation biologics designed to engage multiple immune pathways simultaneously.
Shares of Purple Biotech Ltd. (NASDAQ: PPBT) surged 81.8% to $1.06 on Wednesday after the company announced a major manufacturing milestone for IM1240, the first tri-specific antibody from its CAPTN-3 platform. The achievement marks the successful production of a commercially viable yield, positioning the program competitively as it advances toward clinical development and an Investigational New Drug (IND) submission planned for 2026.
According to CEO Gil Efron, this milestone represents a “major step” for the company’s development pipeline. “We have developed a high-efficiency manufacturing and purification process that is designed to deliver a differentiated T cell engager with a capped, cleavable polypeptide designed to help prevent off-tumor immune activation,” said Efron. The breakthrough, he added, demonstrates the scalability and competitiveness of Purple Biotech’s tri-specific antibody platform.
Dr. Michael Schickler, Head of Clinical and Regulatory Affairs, highlighted the scientific complexity of the achievement. “Producing a tri-specific protein such as IM1240 at high yield and purity was perceived as a significant challenge—one that I’m pleased to have successfully mastered,” he said. IM1240 is designed with a triple mechanism of action, engaging both T cells and NK cells to mount a potent, localized anti-tumor immune response. Its innovative structure includes a protease-cleavable cap that prevents unwanted systemic immune activation, potentially improving safety and extending half-life.
The CAPTN-3 platform represents a new frontier in targeted cancer therapy. By conditionally activating tri-specific antibodies within the tumor microenvironment, the platform confines therapeutic activity to cancerous tissue while sparing healthy cells. IM1240 specifically targets 5T4, a tumor-associated antigen linked to advanced disease and poor clinical outcomes in a variety of solid tumors.
Purple Biotech’s broader pipeline includes IM1305, another tri-specific antibody targeting TROP2, and two additional programs—CM24 and NT219—focused on novel immune evasion and resistance pathways. With today’s milestone, the company underscores its growing leadership in the design and development of complex biologics capable of addressing some of the toughest challenges in oncology drug development.
https://www.theglobeandmail.com/investing/markets/indices/INX/pressreleases/35773704/cancer-immunotherapy-innovators-break-new-ground-in-antibody-engineering/
$PPBT
leverage102
8月前
PPBT BIG NEWS $$$$$. Purple Biotech Achieves Manufacturing Milestone for IM1240, a Tri-Specific Antibody from the CAPTN-3 Platform
+68.08%
Achieved commercially viable yield for IM1240, positioning the program competitively for future development
Validates scalability of the CAPTN-3 tri-specific antibody platform
IM1240, the first CAPTN-3 tri-specific antibody targeting the novel tumor-associated antigen 5T4, advances toward first-in-human clinical trials, with an Investigational New Drug (IND) submission planned for 2026
REHOVOT, Israel, Oct. 29, 2025 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, today announced the achievement of a manufacturing milestone for IM1240, a tri-specific antibody from the CAPTN-3 platform, which targets the tumor-associated antigen 5T4, the activating receptor CD3 on T cells and the inhibitory receptor NKG2A on NK and CD8 T cells.
"Establishing a process capable of producing tri-specific antibodies marks a major step in our development program," said Gil Efron, CEO of Purple Biotech. "We have developed a high-efficiency manufacturing and purification process that is designed to deliver a differentiated T cell engager with a capped, cleavable polypeptide designed to help prevent off-tumor immune activation. This milestone positions our CAPTN-3 platform as an attractive potential solution for developing complex tri-specific antibodies with both competitive yield and purity."
"Drawing on my decades of experience in antibody manufacturing, producing a tri-specific protein such as IM1240 at high yield and purity was perceived as a significant challenge-one that I'm pleased to have successfully mastered," added Dr. Michael Schickler, Head of Clinical and Regulatory Affairs of Purple Biotech. "Our technology is designed to deliver a triple mechanism of action: it activates NK cells and highly cytotoxic T cells by blocking the inhibitory NKG2A--HLA-E interaction and engages cytotoxic T cells through CD3 targeting driving a potent anti-tumor immune response. The antibody's structure incorporates a protease-cleavable albumin-bound cap that prevents systemic CD3 immune activation. By limiting immune activation to the tumor microenvironment, this approach is designed to offer a potentially safer therapeutic profile and an extended half-life."
The CAPTN-3 platform generates conditionally activated tri-specific antibodies, which engage both T cells and NK cells to induce a strong, localized immune response within the tumor microenvironment (TME). The cleavable capping technology confines the compound's therapeutic activity to the local TME, thereby potentially increasing the anticipated therapeutic window in patients. The third arm specifically targets the tumor associated antigen (TAA). This technology presents a novel mechanism of action by unleashing both innate and adaptive immune systems to mount an optimal anti-tumoral immune response.
About Purple Biotech
Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance. The Company's oncology pipeline includes CAPTN-3, CM24 and NT219. The Company is advancing CAPTN-3, a preclinical platform of conditionally activated tri-specific antibodies, which engage both T cells and NK cells to induce a strong, localized immune response within the tumor microenvironment. The cleavable capping technology confines the compound's therapeutic activity to the local tumor microenvironment, thereby potentially increasing the anticipated therapeutic window in patients. The third arm specifically targets the Tumor Associated Antigen (TAA). The technology presents a novel mechanism of action by unleashing both innate and adaptive immune systems to mount an optimal anti-tumoral immune response. IM1240 is the first tri-specific antibody in development that targets the 5T4 antigen, which is expressed in a variety of solid tumors and is associated with advanced disease, increased invasiveness, and poor clinical outcomes. IM1305 is the second tri-specific antibody from the platform in development and targets the TROP2 TAA. CM24 is a humanized monoclonal antibody that blocks CEACAM1, which supports tumor immune evasion and survival through multiple pathways. CEACAM1 on tumor cells, immune cells and neutrophil extracellular traps is a novel target for the treatment of multiple cancer indications. As proof of concept of these novel pathways, the Company completed a Phase 2 study for the treatment of pancreatic ductal adenocarcinoma (PDAC) with CM24 as a combination therapy with the anti-PD-1 checkpoint inhibitor nivolumab and chemotherapy, demonstrating clear and consistent improvement across all efficacy endpoints and the identification of two potential serum biomarkers and other potential tissue biomarkers. NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. A Phase 1 dose escalation study was concluded as a monotherapy and in combination with cetuximab, in which NT219 demonstrated anti-tumor activity in combination with cetuximab in second-line patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). A Phase 2 study in collaboration with the University of Colorado, to treat R/M SCCHN patients with NT219 in combination with cetuximab or pembrolizumab was initiated. The Company's corporate headquarters are located in Rehovot, Israel. For more information, please visit https://purple-biotech.com/.
Forward-Looking Statements and Safe Harbor Statement
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements that are not statements of historical fact, and may be identified by words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences include, among others, risks relating to: the plans, strategies and objectives of management for future operations; product development for NT219, CM24 and CAPTN-3; the process by which such early stage therapeutic candidates could potentially lead to an approved drug product is long and subject to highly significant risks, particularly with respect to a joint development collaboration; the fact that drug development and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to successfully develop and commercialize our pharmaceutical products; the expense, length, progress and results of any clinical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products; patents obtained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain and defend issued patents; the commencement of any patent interference or infringement action against our patents, and our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure to litigation, including patent litigation, and/or regulatory actions, and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2024 and in our other filings with the U.S. Securities and Exchange Commission ("SEC"), including our cautionary discussion of risks and uncertainties under "Risk Factors" in our Registration Statements and Annual Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date on which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement or other information contained herein, whether as a result of new information, future events or otherwise, except as required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC's website, https://www.sec.gov.
CONTACTS:
Company Contact:
IR@purple-biotech.com
(END) Dow Jones Newswires
October 29, 2025 07:33 ET (11:33 GMT)
tw0122
2年前
Purple Biotech Identifies Potential New Serum Biomarker for its Lead Oncology Therapeutic Candidate CM24: Associated with 79% Reduction in Risk of DeathNovember 04 2024 - 7:50AM
Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that overcome tumor immune evasion and drug resistance, today announced it has identified serum CEACAM1 as an additional new potential blood biomarker that may help determine which metastatic pancreatic ductal adenocarcinoma (PDAC) patients are most likely to benefit from treatment with CM24. CM24 is a humanized monoclonal antibody that blocks CEACAM1 binding thereby inhibits its activity. CEACAM1 is overexpressed on certain tumor cells, immune cells, and neutrophils extracellular traps (NETs).PDAC patients who had pretreatment serum CEACAM1 levels between 6K and 15K pg/mL demonstrated the best outcomes following treatment with CM24 and nivolumab in combination with irinotecan/fluoropyrimidine based chemotherapy compared to chemotherapy control, with respect to both progression free survival (PFS) (median = 4.6 months, hazard ratio [HR] < 0.1, P = 0.003) and overall survival (OS) with an 79% reduction in risk of death (HR = 0.21, P = 0.04). The median OS improved from 3.6 months with chemotherapy alone to 8.7 months with the combination.Purple Biotech’s randomized Phase 2 study of CM24 in the second line treatment of PDAC has previously identified multiple potential biomarkers including another serum-based marker, myeloperoxidase (MPO), and tumor markers.“As we look ahead to topline Phase 2 results before the end of the year and anticipate advancing CM24 into further clinical development, the identification of an additional serum biomarker for patient selection is a critical advantage for our future CM24 study and more importantly, potentially for cancer patients in need of better outcomes, particularly for pancreatic cancer,” said Gil Efron, Purple Biotech CEO.
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