Biomica Ltd., an emerging biopharmaceutical company developing innovative microbiome-based therapeutics and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), and Rambam Health Care Campus today announced the signing of a clinical trial agreement (CTA) for initiating a first in-human proof-of-concept (POC) for BMC128, Biomica’s drug candidate.

The study is titled, “A Phase 1, Open-Label Study to Evaluate the Safety and Tolerability of BMC128 in Combination with anti-PD-1 in Patients with Non-small Cell Lung Cancer (NSCLC), Melanoma or Renal Cell Carcinoma (RCC).”  The study 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).

The initiation of this study is pending approval by the Israeli Ministry of Health (MoH).

Dr. Elran Haber, CEO of Biomica, stated: “We are very excited to work with one of Israel’s leading healthcare institutions, the Rambam Health Care Campus, and we look forward to initiating our first in-human POC study for BMC128, for the treatment of refractory cancer patients. Based on the compelling preclinical results achieved to-date, we are thrilled to take this next step in advancing BMC128 through the clinical development process. We hope that this important collaboration will be followed by further partnerships with additional leading medical institutions.”

Dr. Ruth Perets, Head of Rambam’s Oncology Phase 1 Clinical Trials, stated: “We are thrilled to lead this clinical trial, aiming to target the important issue of ICI resistance. ICIs have revolutionized the field of oncology, providing prolonged survival in many malignancies. However, resistance to ICI eventually occurs in most patients, and evidence suggests that the gut microbiota plays a role in ICI resistance. We are excited to the test the ability of BMC128 to overcome ICI resistance and help provide patients meaningful and long responses to treatment.”

As previously reported, treatment with BMC128 in combination with ICI immunotherapy, significantly enhanced anti-tumor activity in various preclinical models. This resulted in an increased response of tumors to anti-PD1, as demonstrated in an improved Objective Response Rate (ORR) and Percent Tumor Growth Inhibition (%TGI). Response to BMC128 was correlated with a desired anti-tumor immunological profile. BMC128 changed the course of response to ICI, leading to stimulation of the immune system which shifted cold-tumors into hot-tumors.

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[1]^,[2]. Fecal microbial transplantation has been recently reported to increase response in patients resistant to immune-checkpoint therapy[3]^,[4]. However, the specific microbial entities driving this response are currently unknown.

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.