Evogene cancer combination therapy meets safety goal in early trial

Evogene (NASDAQ:EVGN) announced that a first-in-human Phase 1 clinical trial evaluating its experimental microbiome-based oncology therapy, BMC128, successfully met its primary safety endpoint when administered in combination with the immunotherapy drug Nivolumab.

The open-label study, conducted by Evogene's subsidiary Biomica, evaluated 11 patients with advanced solid tumors, including non-small cell lung cancer, melanoma, and renal cell carcinoma.

The enrolled cohort consisted of patients whose disease had previously progressed under standard immune checkpoint inhibitor treatments.

BMC128 is a rationally designed live bacterial consortium consisting of four human gut bacterial strains designed to stimulate anti-tumor immune responses and restore sensitivity to immunotherapies.

The combination regimen achieved its primary objective by demonstrating an acceptable safety and tolerability profile, with no dose-limiting toxicities reported among the participants.

The treatment protocol involved a two-week initial induction phase using BMC128 monotherapy, followed by 16 weeks of co-administration alongside Nivolumab.

Beyond establishing safety parameters, the study generated preliminary anti-tumor efficacy signals.

Five of the 11 treated patients achieved stable disease that persisted past the initial 16-week combination phase.

Additionally, two patients maintained their status on the trial through a full two-year longitudinal follow-up period during subsequent Nivolumab maintenance therapy, and one patient recorded a partial response.

These clinical findings support the ongoing development of the therapeutic candidate by Shanghai Lishan Biopharmaceuticals, which secured exclusive worldwide development and commercialization rights to the drug earlier this year.

Under the terms of that licensing agreement, Lishan Biotech has assumed all responsibilities for the global clinical path, manufacturing, and commercial operations for the asset, which it has re-designated as LS-LBP-002.

Following the validation of the Phase 1 safety and translation data, Lishan Biotech plans to accelerate preparation for Phase 2 clinical testing in global markets, including the United States and China.