Bantam Pharmaceutical Starts First Phase 1 Trial at MD Anderson Cancer Center

Bantam Pharmaceutical, an innovative drug discovery firm based in Research Triangle Park, N.C., has taken a significant step forward in cancer treatment research. On February 20, 2025, the company announced the launch of its first clinical trial site at the prestigious University of Texas MD Anderson Cancer Center. This site will be pivotal in conducting a Phase 1 study to evaluate a groundbreaking therapeutic, BTM-3566, aimed at treating relapsed or refractory mature B-cell lymphomas.

BTM-3566 represents a novel class of small molecule cancer therapies, specifically targeting mitochondrial homeostasis through the ATF4-Integrated Stress Response (ISR) pathway. This unique approach aims to provide the aggressive tumor-fighting properties typically associated with chemotherapy, but with the enhanced precision and selectivity found in targeted therapies.

Michael Stocum, Bantam Pharmaceutical's President and CEO, expressed enthusiasm over the collaboration with MD Anderson, a leading institution in cancer research and treatment. He noted that this development marks a crucial transition for Bantam from the discovery phase to clinical development, underscoring the shared dedication to improving patient outcomes through advanced medical research.

The Phase 1 trial is designed as a multicenter, open-label study that will use dose-escalation and expansion methodologies. The objectives are to assess the safety, tolerability, and pharmacokinetic properties of BTM-3566, alongside evaluating its anti-tumor and pharmacodynamic effects. Initial data from this study are anticipated to be available in the latter half of 2025.

Bantam Pharmaceutical remains committed to addressing the pressing need for new treatments in combating aggressive tumors. The company is eager to extend the clinical trial's reach to additional sites across North America in the near future.

BTM-3566 is an oral small molecule engineered to target a spectrum of cancers, including both hematologic and solid tumors. Initially, the 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 trials, BTM-3566 has shown significant anti-cancer effects, leading to notable tumor regression and, in many instances, complete eradication of tumors resistant to current treatments like CAR-T cell therapy. Its mechanism involves disrupting mitochondrial function in tumor cells, thereby activating apoptosis, the natural process of cell death.

Given its distinctive mechanism and promising preclinical outcomes, Bantam is set to expand the clinical development of BTM-3566 into solid tumors, offering potential new hope to patients with limited treatment options.

Bantam Pharmaceutical is at the forefront of using mitochondrial dynamics to fulfill unmet needs in oncology. With a focus on hematological malignancies and plans to venture into solid tumors, Bantam is advancing first-in-class oral therapeutics. The company currently has an active Investigational New Drug (IND) application in the United States and a Clinical Trial Application (CTA) in Canada for BTM-3566, underscoring its commitment to expanding clinical research and development in cancer treatment.