US-based drug discovery and development company Bantam Pharmaceutical announced on Thursday that it is proceeding with a Phase 1 clinical trial evaluating BTM-3566 in relapsed/refractory mature B-cell lymphomas, based on a recent Clinical Trial Application (CTA) approved by Health Canada.

This regulatory milestone enables Bantam to expand its ongoing clinical programme and to activate multiple clinical trial sites in Canada early in the second quarter of 2025.

Health Canada clearance followed the recent activation of Bantam's first US clinical trial site at The University of Texas MD Anderson Cancer Center for its BTM-3566 Phase 1 study. 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 tumours.

The Phase 1 trial is designed to evaluate the safety, tolerability and preliminary efficacy of BTM-3566 in patients with relapsed/refractory mature B-cell lymphomas. The Canadian trial will follow a similar overall design to the ongoing US Phase 1 trial, a multicentre, open-label, and dose-escalation study assessing the safety, tolerability, pharmacokinetics, anti-tumour activity and pharmacodynamic effects of BTM-3566. The dual country strategy was implemented to accelerate the development of BTM-3566 and will support future harmonisation between the studies to generate a robust dataset and inform future development. Initial clinical data from the trial are expected in the second half of 2025.