MaaT Pharma Announces the Initiation of a Phase 2a Investigator-Sponsored Clinical Trial Evaluating MaaT013 in Combination with Immune Checkpoint Inhibitors for Patients with Melanoma
Source: Business Wire, April 2022
MaaT Pharma (EURONEXT: MAAT – the “Company”), a French clinical-stage biotech and a pioneer in the development of microbiome-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer, announced today the initiation of a Phase 2a clinical trial1 sponsored by AP-HP2, evaluating MaaT013, MaaT Pharma’s lead Microbiome Ecosystem Therapy candidate, in combination with immune checkpoint inhibitors (ICI), ipilimumab (Yervoy®) and nivolumab (Opdivo®), which are standard first line treatments for patients with metastatic melanoma.
The Phase 2a clinical trial is coordinated by Professor Franck Carbonnel, MD, Professor of Gastroenterology at the Kremlin-Bicêtre Hospital in Villejuif, France, and is being carried out in collaboration with INRAE3 and Institut Gustave Roussy. The trial is a randomized, placebo-controlled study and is expected to enroll 60 patients in France. The primary endpoint is safety, while the secondary endpoint will evaluate MaaT013’s potential to improve the response to ICI therapies, as a consequence of MaaT013’s impact on the patient’s gut microbiome. Patients will be randomized to receive either MaaT013 in combination with both ICIs or a placebo with both ICIs. MaaT Pharma will provide MaaT013 drug candidate and the placebo for this study as well as perform the microbiome profiling of patients using its proprietary gutPrint® platform. This clinical trial is registered on clinicaltrials.gov.
Several studies have suggested that gut microbiota diversity and richness are predictors of response to ICI treatment4 in patients with solid tumors. Notably, in two recent studies conducted in melanoma patients5, fecal microbiota transfer from ICI therapy responders could overcome resistance to that same therapy in non-responders.
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