Computational chemistry company Evogene Ltd (Nasdaq:EVGN) (TASE:EVGN) announced on Tuesday the successful completion of the first-in-human (FIH) Phase 1 clinical study of BMC128, a rationally-designed live bacterial product developed by its subsidiary, Biomica Ltd, in combination with Nivolumab in patients with advanced solid tumours, including melanoma, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC).

The open-label, single-arm Phase 1 study enrolled 11 patients with advanced solid tumours who had previously progressed following anti-PD-1 immunotherapy, and was designed to evaluate the safety and tolerability of BMC128 in combination with Nivolumab. The treatment regimen included a two-week induction phase with BMC128 monotherapy, followed by 16 weeks of combination treatment with BMC128 and Nivolumab. Patients demonstrating clinical benefit were eligible to continue Nivolumab monotherapy for up to two years or until disease progression.

According to the company, the study successfully met its primary endpoint, demonstrating favourable safety and tolerability, with no dose-limiting toxicities observed.

Preliminary clinical findings demonstrated early signs of anti-tumour activity. Five of the 11 treated patients achieved stable disease beyond the 16-week combination treatment period. Two patients remained on study through the full two-year follow-up period during Nivolumab maintenance therapy, while one patient achieved a partial response.

In addition to clinical observations, Evogene said that translational analyses demonstrated biological signals consistent with the proposed mechanism of action of BMC128. Responding patients showed increased microbiome diversity, evidence of immune activation, and modulation of immune suppression-associated signatures.