Bantam Pharmaceutical has marked a significant milestone in its oncology program with the activation of its first Phase 1 clinical trial site at The University of Texas MD Anderson Cancer Center. The study will evaluate BTM-3566, the company's novel small molecule therapeutic targeting mitochondrial dynamics in relapsed/refractory mature B-cell lymphomas.
Novel Mechanism Targeting Mitochondrial Function
BTM-3566 represents a pioneering approach in cancer treatment, functioning as a first-in-class molecule that disrupts mitochondrial homeostasis through the ATF4-Integrated Stress Response (ISR) pathway. The drug's mechanism aims to deliver chemotherapy-level tumor-killing effectiveness while maintaining the precision typically associated with targeted therapies.
"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. "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."
Trial Design and Expected Outcomes
The Phase 1 study is designed as a multicenter, open-label trial incorporating both dose-escalation and expansion phases. Researchers will evaluate multiple critical parameters:
- Safety and tolerability profiles
- Pharmacokinetic characteristics
- Anti-tumor efficacy
- Pharmacodynamic effects
Initial clinical data from the trial is anticipated in the second half of 2025, with plans to expand to additional North American sites in the coming months.
Strong Preclinical Foundation
BTM-3566's development is supported by compelling preclinical data demonstrating significant anti-cancer activity. The drug has shown remarkable efficacy in tumor models resistant to standard treatments, including CAR-T cell therapy, achieving substantial tumor regression and, in many cases, complete tumor elimination.
The initial clinical focus encompasses several types of mature B-cell lymphomas:
- Mantle cell lymphoma (MCL)
- Diffuse large B-cell lymphoma (DLBCL)
- Follicular lymphoma (FL)
Broader Therapeutic Potential
While the current trial focuses on hematologic malignancies, Bantam Pharmaceutical has outlined plans to expand BTM-3566's clinical development into solid tumors. This strategic expansion could potentially address significant unmet needs across multiple cancer types, particularly benefiting patients with limited treatment options.
The trial is registered on ClinicalTrials.gov under the identifier NCT06792734, marking an important advancement in the development of novel cancer therapeutics targeting mitochondrial function.
