Evogene Completes BMC128 Phase 1 Trial, Shows Safety and Stable Disease in 5 of 11 Patients
EVGN•Evogene’s subsidiary Biomica completed a first-in-human Phase 1 trial of BMC128 with Nivolumab in 11 advanced solid tumor patients, meeting its primary endpoint with no dose-limiting toxicities. Five patients achieved stable disease beyond 16-week combination treatment and one had a partial response, with translational analyses showing immune activation signals.
1. Trial Design and Objectives
Biomica initiated an open-label, single-arm Phase 1 study enrolling 11 patients with advanced melanoma, renal cell carcinoma and non-small cell lung cancer who had progressed after anti-PD-1 therapy. The protocol included a two-week induction period of BMC128 monotherapy followed by 16 weeks of BMC128 combined with Nivolumab, with continued Nivolumab maintenance for responders up to two years.
2. Safety and Efficacy Results
The study met its primary endpoint, reporting no dose-limiting toxicities across all dosing cohorts. Five of 11 patients maintained stable disease beyond the 16-week combination phase, one patient achieved a partial response, and two continued on Nivolumab through the full two-year maintenance window.
3. Translational Findings and Licensing
Translational analyses demonstrated increased gut microbiome diversity and immune activation signatures in responding patients, supporting BMC128’s proposed mechanism. Evogene has licensed the program to Lishan Biotech under the LS-LBP-002 designation and is collaborating on planning of the next-stage clinical development.
