Microbiome therapeutic shows potential in refractory cancers

The microbiome

Biomica has revealed encouraging initial findings from an ongoing Phase I clinical trial of its microbiome-based immuno-oncology candidate, BMC128, in combination with an anti-PD1 immune checkpoint inhibitor.

The trial is assessing the drug in patients with non-small cell lung cancer (NSCLC), melanoma, or renal cell carcinoma (RCC).

All 11 trial participants had experienced disease progression in prior immunotherapy treatment before joining the trial.

These preliminary findings represent some of the initial positive evidence emerging from the burgeoning field of clinical research on cancer therapies leveraging gut microbiota. They suggest potential benefits for patients facing advanced stages of these malignancies.

Dr Elran Haber, Biomica CEO, stated: “The preliminary results from this Phase I study show positive evidence of BMC128’s superior safety profile and potential efficacy when combined with anti-PD1 checkpoint inhibitor immunotherapy. This suggests potential benefits for patients with refractory NSCLC, melanoma, or RCC who have not responded to, or developed resistance to previous immunotherapy treatments. We believe BMC128 has the promise to be a potential therapy for patients fighting cancer, and we look forward to continuing to evaluate BMC128’s beneficial activity in subsequent phases of clinical development.”

Phase I trial results

Among the patients included in the study, 72% of refractory cases exhibited positive clinical signals, indicating a potential efficacy for the BMC128 and nivolumab combination.

One patient demonstrated partial response (PR) and remains actively responding to treatment. Additionally, 64% of patients’ disease stopped progressing following the combination treatment, and they displayed stable disease (SD) and sustained benefits beyond the first imaging assessment.

Fifty-five percent of patients showed sustained clinical benefit, with notable durations of response of over 16 weeks and with one patient exceeding 80 weeks.

All RCC patients and 60% of NSCLC patients in the study demonstrated positive clinical outcomes, indicating potential efficacy across different cancer types.

Professor Gal Markel, Director of the Davidoff Cancer Center, Rabin Medical Center and Biomica’s Scientific Advisory Board member, said: “The positive trends emerging from the ongoing Phase I trial of BMC128, particularly in combination with nivolumab, underscore the transformative potential of microbiome-based therapeutics in oncology. Additionally, the observed cross-cancer effectiveness hints at BMC128’s broad applicability across different cancer types, further solidifying its significance in the field of oncology. The demonstrated safety profile thus far, alongside the encouraging clinical benefits including response rate and notable durability, accentuates the potential efficacy of BMC128 in addressing the unmet needs of patients grappling with these malignancies.”

Diana Spencer, Senior Digital Content Editor, DDW

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