On February 20, 2025 Bantam Pharmaceutical, a drug discovery and development company targeting selective modulation of mitochondrial dynamics in cancer, reported the activation of its first clinical trial site at The University of Texas MD Anderson Cancer Center for its Phase 1 study evaluating BTM-3566 in relapsed/refractory mature B-cell lymphomas (Press release, Bantam Pharmaceutical, FEB 20, 2025, View Source [SID1234650429]). BTM-3566 is a first-in-class, small molecule cancer therapeutic which targets mitochondrial homeostasis via the ATF4-Integrated Stress Response (ISR) pathway to treat aggressive tumors.
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"We are pleased to activate our first clinical site at MD Anderson Cancer Center, a world-renowned institution known for its leadership in cancer research and treatment," said Michael Stocum, President & CEO of Bantam Pharmaceutical. "This represents a major milestone for our company as we transition from discovery into clinical development. Through its novel mechanism of action, BTM-3566 has the potential to deliver the tumor-killing potency of chemotherapy with the precision and selectivity of targeted therapies. We are excited to partner with MD Anderson and believe this collaboration reflects our shared commitment to advancing medical research and improving patient outcomes."
The Phase 1 clinical trial is a multicenter, open-label, dose-escalation and -expansion study. The study will evaluate the safety, tolerability, pharmacokinetics, anti-tumor, and pharmacodynamic effects of BTM-3566. Initial clinical data from the trial are expected in the second half of 2025.
Bantam remains dedicated to addressing the need for new treatments targeting aggressive tumors and looks forward to expanding the clinical trial to additional North American sites in the coming months.
For more information about the trial, visit ClinicalTrials.gov and search NCT number NCT06792734.
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 tumor 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.