The scale-up and GMP batch production is to support the preparation towards the anticipated first in man proof of concept clinical trials
Rehovot, Israel – January 13, 2020 – Biomica, an emerging biopharmaceutical company developing innovative microbiome-based therapeutics, and a subsidiary of Evogene Ltd. (NASDAQ, TASE: EVGN), announced today that it has entered a service agreement with Biose Industrie, a France based CDMO, for the scale-up production of its drug candidates, microbial consortia BMC121 & BMC127 for its Immuno-Oncology program. This agreement will accelerate the Company’s Immuno-Oncology program which is currently planned to enter the clinic in 2021 for proof of concept studies.
Biose Industrie is a drug-GMP certified manufacturer of bacteria-based APIs and clinical and commercial products. Biomica engaged with Biose for the scale-up development and GMP production of a clinical batch of its drug candidates.
As previously announced, BMC121 & BMC127 were recently evaluated in pre-clinical studies in a mouse cancer model under Biomica’s immuno-oncology program, aiming to improve the efficacy of immune checkpoint inhibitors therapy. The results of these trials validated the Company’s computational predictions by demonstrating preliminary positive effects when administered in combination with checkpoint inhibitor therapy (anti-PD1), compared to using checkpoint inhibitor therapy alone. This effect was manifested in improved anti-tumor immune response through multiple bacterial-induced mechanisms of action.
Dr. Elran Haber, Biomica CEO, stated: “We are very pleased to work with Biose Industrie, an expert in GMP manufacturing of bacteria-based therapeutics. In parallel with on-going additional preclinical activities, this is an important step in the advancement of our Immuno-Oncology program, as we prepare for initiation of first in man, proof of concept clinical trials that are currently anticipated to begin next year.”
Dr. Adrien Nivoliez, Biose industrie CEO, stated: “Biose Industrie is proud to collaborate with Biomica in the development of this novel LBP within the exciting field of Immuno-Oncology. This is another example of Biose Industrie’s ability to support and partner for both Drug Product and Drug Substance within the world of Microbiome Therapeutics, assisting Biotech’s and pharmaceutical companies in their drive to treat patients.”
About BMC121 & BMC127
Developed as Live Bacterial Products (LBPs), BMC121 & BMC127 are rationally-designed LBP consortia comprised of unique bacterial strains 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.
Biomica is an emerging biopharmaceutical company developing innovative microbiome-based therapeutics utilizing a dedicated Computational Predictive Biology platform (CPB), licensed from Evogene. Biomica aims to identify and characterize disease-related microbiome entities and to develop novel therapeutics based on these understandings. The company is focused on the development of therapies for antibiotic resistant bacteria, immuno-oncology, and microbiome-related gastrointestinal (GI) disorders.
Biomica is a subsidiary of Evogene Ltd. (NASDAQ, TASE: EVGN). For more information, please visit www.biomicamed.com.
About Evogene Ltd.:
Evogene (NASDAQ, TASE: EVGN) is a leading biotechnology company developing novel products for major life science markets through the use of a unique computational predictive biology (CPB) platform incorporating deep scientific understandings and advanced computational technologies. Today, this platform is utilized by the Company to discover and develop innovative products in the main following areas (via subsidiaries or divisions): ag-chemicals, ag-biologicals, seed traits, human microbiome based therapeutics and medical cannabis. Each subsidiary or division establishes its product pipeline and go-to-market, as demonstrated in their collaborations with world-leading companies such as BASF, Bayer, Corteva, and ICL. For more information, please visit www.evogene.com.
Forward Looking Statements
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