Biomica Announces Clearance for First-in-Human Phase I Study of BMC-128 in Combination with Bristol Myers Squibb’s Anti-PD-1 Opdivo®

On January 11, 2022 Biomica Ltd., an emerging biopharmaceutical company developing innovative microbiome-based therapeutics and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), reported that the Israeli Ministry of Health (MoH) cleared the company to proceed with its Proof-of-Concept (POC), Phase I clinical trial of Biomica’s drug candidate BMC-128 in patients with Non-Small Cell Lung Cancer (NSCLC), Melanoma or Renal Cell Carcinoma (RCC), in combination with immune checkpoint inhibitor (ICI) immunotherapy (an anti-PD-1 agent) (Press release, Biomica, JAN 11, 2022, View Source [SID1234598607]).

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Biomica has entered into a supply agreement for the utilization of Bristol Myers Squibb’s (BMS) Opdivo to evaluate the safety and tolerability of BMC-128 therapy in combination with nivolumab (Opdivo), a human anti-PD-1 therapy, in multiple cancer indications.

The POC combination trial is designed to be a first-in-human (FIH) open-label study to evaluate the safety and tolerability of BMC-128 in combination with BMS’ Opdivo in patients with NSCLC, melanoma or RCC, clinical signals will be monitored as well. This study is expected to take place at Rambam Health Care Campus, as previously announced[1].

About BMC128:

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.