Study Results Demonstrated Favorable Safety Profile and Preliminary Signals of Clinical Activity

Article Source：Evogene Official Website

https://evogene.com/newsroom/press-release/evogene-announces-successful-completion-of-phase-1-clinical-study-of-bmc128-a-rationally-designed-live-bacterial-product-in-combination-with-nivolumab-by-its-subsidiary-biomica/

REHOVOT, Israel, June 2, 2026 – Evogene Ltd. (“Evogene”) (Nasdaq/TASE: EVGN), a pioneering computational chemistry company specializing in generative design of small molecules for the pharmaceutical and agricultural industries, today announced 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 tumors, 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 tumors 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.

The study successfully met its primary endpoint, demonstrating favorable safety and tolerability, with no dose-limiting toxicities observed.

Preliminary clinical findings demonstrated early signs of anti-tumor activity. Five of the eleven 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, 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.

Ofer Haviv, President and CEO of Evogene and Biomica, commented:
“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. 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 this year, Evogene, through its subsidiary Biomica, entered into a licensing agreement with Lishan Biotech for the continued clinical development and commercialization of BMC128, now designated LS-LBP-002.

Dr. Weijie Chen, President and CEO of Lishan Biotech, added: “We are highly encouraged by the favorable safety profile and preliminary efficacy signals results generated in this Phase 1 study. These results not only provide important support for the continued advancement of LS-LBP-002, formerly BMC128, but also strengthen our confidence in the rationale of rationally designed live bacterial products combined with immune checkpoint inhibitors.

Based on this positive data, we are accelerating our planning for the next-stage clinical development. We look forward to further evaluating the therapeutic potential of this novel microbiome-based approach and bringing this promising candidate closer to patients in need.”

About BMC128

BMC128 is a rationally designed live bacterial therapeutic candidate developed to facilitate anti-tumor immune responses in patients receiving immune checkpoint inhibitors. The product consists of a defined consortium of bacterial strains selected based on Evogene’s computational microbiome discovery platform and preclinical validation studies.

Under the licensing agreement with Lishan Biotech, BMC128 is being further developed under the designation LS-LBP-002.

About Lishan Biotech:

Lishan Biotech is a biotechnology company focused on the development of live biotherapeutic products (LBPs). We aim to address the substantial unmet clinical needs for complex diseases including inflammatory bowel disease, oncology and neurological disorders. Adopting an “AI + Microbiome” strategy, we combine gut microbiota regulation and host pathway intervention to create synergistic effects and expand the boundaries of microbiome-based therapeutics. Leveraging our proprietary Swarming technology and AI-driven clinical enrollment strategies, Lishan Biotech is evolving into a globally leading innovation platform in microbiome therapeutics.

For more information, please visit www.lishan.ltd/en

About Evogene Ltd.

Evogene Ltd. (Nasdaq/TASE: EVGN) is a pioneering company in computational chemistry, specializing in the generative design of small molecules for drug development and agchemical products.

At the core of its technology is ChemPass AI™, a proprietary generative AI designed to explore vast chemical space and generate novel, highly potent small molecules optimized across multiple critical parameters. Built on this powerful technological foundation, and through strategic partnerships alongside internal product development, Evogene is focused on creating breakthrough products for the pharmaceutical and agricultural industries, driven by the integration of scientific innovation with real-world industry needs.

For more information, please visit www.evogene.com