On July 11, 2022 Biomica Ltd., an emerging biopharmaceutical company developing innovative microbiome-based therapeutics and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), reported the successful enrollment of the first patient in its first Proof-of-Concept (POC) Phase I clinical trial (Press release, Evogene, JUL 11, 2022, View Source [SID1234616583]).
The trial is designed primarily to evaluate the safety and tolerability of Biomica’s microbiome-based immuno-oncology drug candidate, BMC128, in combination with immune checkpoint inhibitor (ICI) immunotherapy (an anti PD-1 agent), in patients with either non-small cell lung cancer, melanoma or renal cell carcinoma. Bristol Myers Squibb’s Opdivo is the immune checkpoint inhibitor in the trial.
It has been previously reported that treatment with Biomica’s BMC128 in combination with ICI immunotherapy significantly enhanced anti-tumor activity in various preclinical models. Response to BMC128 was correlated with a desired anti-tumor immunological profile and led to a stimulation of the immune system shifting cold-tumors into hot-tumors.
BMC128 is a rationally designed consortium of microbes, which was identified and selected through a detailed functional microbiome analysis using PRISM, a high-resolution microbiome analysis platform powered by Evogene’s ‘MicroBoost AI’ tech engine and Big-Data platform.
Dr. Elran Haber, CEO of Biomica, stated: "We are very excited with our first patient in, under our first in-human, proof-of-concept trial. ICIs are a revolutionary treatment and have demonstrated their efficacy in prolonged survival rates of cancer patients. However, many patients are resistant to ICI, and it has been shown that the gut microbiome plays an important role in this resistance. Based on the compelling pre-clinical results that Biomica has achieved to-date, we are excited to evaluate BMC128 in a clinical setting for the first time. Our goal is to provide patients with a meaningful recovery, improved outcome and long-term response to treatment. We are thrilled in reaching this milestone and we look forward to embarking on the next phase of our clinical development process."
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BMC128 is a rationally designed microbial consortium 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.
Developed as a Live Bacterial Product (LBP), BMC128 is an LBP consortium comprised of four 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 through 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.