REHOVOT, Israel, June 2, 2026
Evogene Ltd. has announced the successful completion of the first-in-human Phase 1 clinical study of BMC128, a rationally designed live bacterial therapeutic developed by its subsidiary Biomica, in combination with Nivolumab for the treatment of advanced solid tumors. The study marks a significant milestone in the emerging field of microbiome-based cancer immunotherapy, demonstrating a favorable safety profile and encouraging preliminary signs of anti-tumor activity in patients who had previously failed anti-PD-1 immunotherapy. Conducted in patients with advanced melanoma, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC), the trial evaluated the ability of BMC128 to enhance immune responses when administered alongside the immune checkpoint inhibitor Nivolumab. The successful completion of the study provides important clinical validation for Biomica’s innovative microbiome platform and strengthens growing scientific evidence that precisely designed bacterial therapeutics may play a critical role in improving outcomes for patients with difficult-to-treat cancers. The results also support continued development of the therapy by Biomica’s licensing partner, Lishan Biotech, which is advancing the candidate under the designation LS-LBP-002.
Phase 1 Study Demonstrates Strong Safety and Tolerability
The open-label, single-arm Phase 1 study enrolled 11 patients with advanced solid tumors who had experienced disease progression despite prior treatment with anti-PD-1 immunotherapy. Participants received an initial two-week induction period with BMC128 monotherapy, followed by sixteen weeks of combination treatment with BMC128 and Nivolumab. Patients who demonstrated clinical benefit were eligible to continue Nivolumab maintenance therapy for up to two years.
The study successfully achieved its primary objective by demonstrating a favorable safety and tolerability profile, with no dose-limiting toxicities reported throughout the trial. Safety remains a critical factor in the development of live bacterial therapeutics, and the positive findings provide an important foundation for future clinical advancement. The successful completion of the first-in-human trial further validates Biomica’s approach to designing microbiome-based medicines capable of modulating immune responses while maintaining acceptable tolerability in cancer patients.
Encouraging Early Signs of Clinical Activity
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Beyond safety outcomes, investigators observed promising preliminary evidence suggesting potential anti-tumor activity. Among the eleven treated patients, five achieved stable disease beyond the sixteen-week combination treatment period, while two patients remained on study throughout the full two-year follow-up period during Nivolumab maintenance therapy. Notably, one patient achieved a partial tumor response, indicating measurable clinical benefit despite prior resistance to checkpoint inhibitor therapy.
These findings are particularly important because the study population consisted of patients with advanced cancers who had already experienced disease progression following immunotherapy treatment. Researchers believe the results suggest that microbiome modulation may help overcome resistance mechanisms that limit the effectiveness of immune checkpoint inhibitors. Although larger controlled studies will be required to confirm efficacy, the initial observations provide a strong rationale for continued clinical development and further evaluation of BMC128 in immuno-oncology settings.
Translational Data Supports Novel Microbiome-Based Mechanism
In addition to clinical observations, the study generated compelling translational evidence supporting the proposed biological mechanism of BMC128. Researchers reported that patients demonstrating clinical benefit exhibited increased microbiome diversity, enhanced immune activation, and reductions in immune suppression-associated signatures. These findings align with the therapeutic hypothesis that carefully selected bacterial strains can positively influence host immune function and improve anti-tumor responses. BMC128 consists of a defined consortium of bacterial strains identified through Evogene’s computational microbiome discovery platform and validated through extensive preclinical research.
The integration of computational biology, artificial intelligence, and microbiome science represents a rapidly advancing area of oncology innovation aimed at improving the effectiveness of immunotherapy. Following the positive Phase 1 results, Lishan Biotech is accelerating planning for the next stage of clinical development to further evaluate the therapeutic potential of LS-LBP-002. As interest in microbiome-based medicines continues to grow, the successful completion of this first-in-human study positions Evogene and Biomica among the leaders developing next-generation immunotherapy solutions capable of addressing significant unmet needs in cancer treatment.
Source: Evogene press release
