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

Biomica Ltd., an emerging biopharmaceutical company developing innovative microbiome-based therapeutics and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), today announced 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).

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].