#Israel #Rehovot #Nivolumab #Evogene #Biomica

Evogene's Promising Horizons: BMC128 Clinical Study Milestone

On June 2, 2026, Evogene Ltd., a leader in computational chemistry, reported the positive outcomes of its first Phase 1 clinical study involving BMC128. This novel live bacterial product, designed by their subsidiary Biomica, was administered in conjunction with Nivolumab, an immunotherapy used for treating advanced solid tumors. The trial, which took place in Rehovot, Israel, emerged as a significant stride in the realm of oncological therapies, particularly for patients with conditions such as melanoma, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC).

Study Design and Patient Demographics

The open-label, single-arm study engaged eleven patients, all suffering from advanced solid tumors that had previously shown resistance to anti-PD-1 therapies. The main aim was to assess both the safety and tolerability of BMC128 alongside Nivolumab. The treatment protocol comprised a two-week induction phase solely utilizing BMC128, followed by a 16-week regimen which included a combination of the two therapies. Patients that exhibited a therapeutic benefit were granted the opportunity to extend their Nivolumab treatment for up to two years, pending disease progression.

Results and Safety Profile

The trial successfully achieved its primary objective, revealing an encouraging safety profile with no observed dose-limiting toxicities. This positive finding is vital in the rigorous field of oncology where treatment tolerability is crucial. Preliminary results also unveiled promising anti-tumor activity, as five out of the eleven participants maintained stable disease outcomes beyond the completion of the combination phase. Furthermore, two patients continued with Nivolumab for the full two years without any signs of abrupt disease advancement, while one patient experienced a partial response to the treatment.

Insights from Translational Analyses

Notably, translational investigations complemented these clinical observations, revealing biological responses aligning with the anticipated mechanism of action for BMC128. Patients who responded positively presented increased microbiome diversity, heightened immune activation, and detectable modulation of immune suppression signatures. These findings came as a breakthrough for the team at Evogene, painting a hopeful picture for future treatments of advanced cancer patients who have limited options.

Statements from Leadership

Ofer Haviv, President and CEO of both Evogene and Biomica, expressed his enthusiasm: "Completing this first-in-human study is a monumental achievement for the BMC128 development program and reinforces the promise of microbiome-focused approaches in immuno-oncology. The favorable safety profile, coupled with initial signs of clinical activity and supportive translational data, further solidifies our commitment to advancing BMC128 alongside our licensing partner, Lishan Biotech."

Dr. Weijie Chen, President and CEO of Lishan Biotech, echoed this optimism. He emphasized the impact of the study results: "The encouraging safety profile and initial efficacy signals foster our confidence in the strategic integration of rationally designed live bacterial products with immune checkpoint inhibitors. These advancements inspire us to expedite our plans for forthcoming clinical developments in this area."

What Lies Ahead

BMC128 is an innovative therapeutic candidate developed to elicit anti-tumor immune responses in patients undergoing treatment with immune checkpoint inhibitors such as Nivolumab. By leveraging a defined consortium of bacterial strains selected through Evogene's advanced microbiome discovery technologies, BMC128 showcases the intersection of biotherapy and cutting-edge computational methodologies.

As outlined in the licensing agreement with Lishan Biotech, further clinical progress is anticipated under the new designation LS-LBP-002. This noteworthy collaboration underscores a shared vision to address significant unmet clinical needs within complex diseases, paving a pathway toward transformative treatments.

Conclusion

Overall, the successful completion of this initial clinical study positions Evogene and its subsidiary at the forefront of innovative cancer treatments. As the results manifest a dual promise of safety and preliminary efficacy, stakeholders await the next phase of BMC128’s development, hopeful for new avenues in cancer therapy.