Evogene has reported positive Phase 1 data for microbiome-based therapy BMC128 in combination with nivolumab in patients with advanced solid tumours.

Evogene has announced the completion of a first-in-human Phase 1 study of BMC128, a live bacterial product developed by its subsidiary Biomica, in combination with nivolumab for patients with advanced solid tumours.

The open-label, single-arm trial enrolled 11 patients with melanoma, renal cell carcinoma and non-small cell lung cancer whose disease had progressed following previous anti-PD-1 immunotherapy treatment.

The study was designed to evaluate the safety and tolerability of BMC128 alongside nivolumab. Patients initially received BMC128 alone for two weeks before moving to 16 weeks of combination treatment. Those experiencing clinical benefit could continue on nivolumab maintenance treatment for up to two years or until disease progression.

According to Evogene, the study met its primary endpoint, demonstrating a favourable safety and tolerability profile. The company reported that no dose-limiting toxicities were observed during the trial.

Preliminary efficacy findings also suggested anti-tumour activity. Five of the 11 patients achieved stable disease beyond the 16-week combination treatment period. Two patients remained on study throughout the full two-year follow-up period while receiving nivolumab maintenance therapy, and one patient achieved a partial response.

The company also reported translational findings that it said were consistent with the proposed mechanism of action for BMC128. Responding patients demonstrated increased microbiome diversity, evidence of immune activation and changes in immune suppression-associated signatures.

Ofer Haviv, president and CEO of Evogene and Biomica, said: “Completion of this first-in-human study represents an important milestone for the BMC128 development program and further supports the potential of microbiome-based approaches in immuno-oncology.”

He added: “We are encouraged not only by the favorable safety and tolerability profile observed in the study, but mainly by the preliminary signals of clinical activity and the translational data supporting the proposed mechanism of action of BMC128. We believe these findings support the continued clinical development of BMC128 by our licensing partner, Lishan Biotech.”

Earlier in 2026, Biomica entered a licensing agreement with Lishan Biotech, which is now responsible for the continued clinical development of the candidate. Under the agreement, BMC128 has been renamed LS-LBP-002.

Lishan Biotech plans to advance the programme into its next stage of clinical development. The company said the Phase 1 results support further investigation of live bacterial therapeutics combined with immune checkpoint inhibitors.

Microbiome-based therapies have attracted increasing interest in oncology as researchers explore whether modulation of gut bacteria can improve responses to immunotherapy. While the findings reported for BMC128 remain early-stage, the study provides initial safety data and signs of biological activity that could inform future clinical trials.

Further studies will be needed to establish efficacy in larger patient populations and determine whether the treatment can improve outcomes compared with current standards of care.