BTM-3566

• BTM-3566 shows solid tumor regression and identifies FAM210B as a potential biomarker for response and combination strategies RESEARCH TRIANGLE PARK, N.C., April 25, 2025 /PRNewswire/ -- Bantam Pharmaceutical, a drug discovery and development company targeting selective modulation of mitochondrial dynamics in cancer, today announced solid tumor regression data from Bantam's lead product candidate, BTM-3566. These preclinical data will be shared in a poster presentation during the American Association for Cancer Research (AACR) Annual Meeting, being held from April 25-30, 2025 at the McCormick Place Convention Center in Chicago, Illinois. The poster highlights evidence of robust anti-tumor activity in a broad range of solid tumor models, as well as introduces FAM210B, a mitochondrial protein, as a potential biomarker for response. BTM-3566 is a first-in-class, small molecule cancer therapeutic which targets difficult-to-treat, aggressive tumors by activating OMA1-ATF4 Integrated Stress Response (ISR), a newly described mitochondrial homeostasis pathway. Previously, BTM-3566 was shown to have strong single-agent activity in both cell line and patient-derived xenograft (PDX) models of mantle cell lymphoma (MCL) and diffuse large B-cell lymphoma (DLBCL), regardless of cell of origin (COO) or genotype. The new data extend these findings to solid tumors and demonstrate that BTM-3566 has in vitro and in vivo activity across tumor types. Key findings include: BTM-3566 exhibits in vitro and in vivo activity in a broad range of solid tumor models BTM-3566 drives tumor regression in models with low FAM210B RNA expression, supporting the use of FAM210B as a potential biomarker for response Ectopic expression of FAM210B blocks drug activity in multiple models, suggesting a mechanistic role for the protein in mediating response BTM-3566 demonstrates additive and synergistic activity in combination with other agents from multiple classes in preclinical models, including BH3 mimetics, supporting future combination strategies "These findings provide important insight into the unique mechanism of our lead compound and support the potential for future patient selection using FAM210B expression," said Michael Stocum, President & CEO of Bantam Pharmaceutical. "We believe BTM-3566 holds promise not only as a monotherapy but also in combination with numerous approved anti-cancer agents, potentially expanding treatment options for patients with aggressive, hard-to-treat tumors. We intend to further explore these relationships as product development progresses." Poster Presentation Details Title: Selective pharmacological activation of the mitochondrial protease OMA1 inhibits tumor growth and induces regression in tumors expressing low levels of FAM210B Presenter: Matthew Kostura, PhD, Chief Scientific Officer, Bantam Pharmaceutical Session: Experimental and Molecular Therapeutics Date/Time: Monday, April 28th at 3 p.m. to 6 p.m. ET Abstract Number: 3032 The poster presentation will be available under the News & Resources section of the company's website shortly after the event. About BTM-3566 BTM-3566 is a novel, orally available small molecule designed to target a wide range of cancers, including both hematologic and solid tumors. Its initial clinical focus is on mature B-cell lymphomas, such as mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma (FL). In preclinical studies, BTM-3566 demonstrated potent anti-cancer activity, driving significant tumor regression – and in many cases, complete tumor elimination – in models resistant to standard treatments, including CAR-T cell therapy. BTM-3566 works by disrupting the mitochondrial function in tumor cells, triggering their natural cell death process (apoptosis). With its unique mechanism of action and strong preclinical data, Bantam also plans to expand clinical development into solid tumors, broadening its potential impact for patients with limited treatment options. Currently, Bantam is conducting an ongoing Phase 1 clinical trial in both the U.S. and Canada evaluating BTM-3566 in relapsed/refractory mature B-cell lymphomas. For more information about the U.S. trial, visit ClinicalTrials.gov and search NCT06792734. About Bantam Pharmaceutical Bantam Pharmaceutical is a drug discovery and development company leveraging the power of mitochondrial dynamics to address critical unmet needs in oncology. Using its unique expertise in mitochondrial cellular biology, Bantam is advancing novel, first-in-class oral small molecule therapeutics for difficult-to-treat hematological and solid tumors. The company currently holds an active Investigational New Drug (IND) application in the U.S. and a Clinical Trial Application (CTA) in Canada for its lead candidate, BTM-3566, targeting B-cell malignancies, with plans to expand clinical development into solid tumors. Learn more at . Media Contact Jennifer Almond Corporate Communications Bantam Pharmaceutical [email protected] SOURCE Bantam Pharmaceutical, LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED