Biomica Ltd., an emerging biopharmaceutical company developing innovative microbiome-based therapeutics, and a subsidiary of Evogene Ltd. announced positive pre-clinical in-vivo results in its immuno-oncology program for a follow-on combination of bacterial strains. In these studies, Biomica tested BMC128, which consists of four live bacterial strains derived from Biomica's drug candidates BMC121 and BMC127. Treatment with BMC128, both prior to and in combination with ICI, significantly improved anti-tumor activity in mice.

These positive results supplement additional positive data using Biomica's initial bacterial strain combinations BMC121 and BMC127, which demonstrated anti-tumor activity in animal studies. BMC128 was selected based on further predictive analysis of the results of Biomica's studies with BMC121 and BMC 127.

Biomica's immuno-oncology program is based on the premise that the gut microbiome affects the efficacy of cancer immunotherapy, specifically that of the ICI involving the blockade of PD-1 or PD-L1 and CTLA-4, as suggested in scientific literature. In the current study, BMC128 was administered to mice bearing cancer tumors prior to and during ICI therapy. BMC128 is a rationally-designed microbial consortium derived from Biomica's earlier candidates BMC121 and BMC127, which had been identified and selected through a detailed functional microbiome analysis using PRISM, a proprietary high-resolution microbiome analysis platform powered by Evogene's MicroBoost AI platform.

Biomica's current results demonstrate that treatment with BMC128 prior to and in combination with the administration of ICI, significantly reduced tumor volume and increased animal survival compared to ICI therapy alone. Moreover, treatment with BMC128 affected several immunological factors, including specific immune-cells populations known to be involved in tumor destruction.

The study indicates that treatment with BMC128 conditions the immune system and primes it for an efficient, well-orchestrated anti-tumor response. This is in-line with numerous scientific publications, demonstrating the effect of the gut microbiome on the response to ICI, and more specifically a reduced response to ICI in patients with compromised microbiome following treatment with antibiotics.

As previously disclosed, Biomica has initiated scale-up processes for Good Manufacturing Practice (GMP) production of its drug candidates in its immuno-oncology program in preparation for the expected first-in-man proof-of-concept clinical trials next year, following expected additional pre-clinical studies during 2020.

Dr. Elran Haber, CEO of Biomica stated: "We are very excited with the results of this study using BMC128, which demonstrate the potential of Biomica's drug candidates in improving care for cancer patients treated with immunotherapy. We believe these results indicate that live biotherapeutic drugs may potentially be used as a stand-alone priming therapy or as combination therapy with ICI in order to improve the response of cancer patients. We look forward to providing incremental updates as we work towards first-in-man proof-of-concept clinical trials."

Ofer Haviv, Chairman of Biomica and Evogene's President and CEO stated: "I am very proud of Biomica's rapid progress. We believe that these pre-clinical results are a clear demonstration of the advantages that can be provided by predictive biology, powered by big data analysis and artificial intelligence, for increasing the efficacy of immunotherapy. In addition, we believe that this success underpins the broad applicability of Evogene's unique Computational Predictive Biology (CPB) platform in multiple major market areas."

About BMC121, BMC127 and BMC128

Developed as Live Bacterial Products (LBPs), BMC121 and BMC127 are rationally-designed LBP consortia comprised of unique bacterial strains, natural inhabitants of the human intestinal tract, that harbor specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity though multiple biological processes.

Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a host's microbial community with individually selected, cultured bacteria.

BMC128 consists of four bacterial strains derived from Biomica's drug candidates BMC121 and BMC127.