Biomica has completed enrolment in its Phase I trial evaluating the safety and tolerability of its microbiome-based immuno-oncology drug, BMC128.

Initiated in July 2022, the Phase I trial was designed to evaluate BMC128 in combination with immune checkpoint inhibitor (ICI) immunotherapy, in patients with either non-small cell lung cancer (NSCLC), melanoma or renal cell carcinoma (RCC), who previously progressed on immunotherapy.

Bristol Myers Squibb’s Opdivo is the immune checkpoint inhibitor in the trial. The study is taking place at The Davidoff Center and the Rambam Health Care Campus in Israel. The first data point readout is expected in H1 2024.

Dr Elran Haber, CEO of Biomica, stated: “We are pleased to complete the Phase I Proof of Concept study enrolment, marking a critical step forward in developing our groundbreaking BMC128. We are excited about the progress made thus far and confident about the potential of BMC128 to address the unmet needs in the treatment of ICI-refractory cancer patients.”

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 MicroBoost AI tech engine.

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 harbour specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumour 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.