On April 7, 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, reported the initiation of a Phase 2a clinical trial[1] sponsored by AP-HP[2], 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 (Press release, MaaT Pharma, APR 7, 2022, View Source [SID1234611593]).
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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 INRAE[3] 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 treatment[4] in patients with solid tumors. Notably, in two recent studies conducted in melanoma patients[5], fecal microbiota transfer from ICI therapy responders could overcome resistance to that same therapy in non-responders.
[1] NCT04988841: Prospective randomIzed clinical trial assessing the tolerance and clinical benefit of feCAl tranSplantation in patientS with melanOma treated with CTLA-4 and PD1 inhibitors.
[2] AP-HP: Assistance Publique – Hôpitaux de Paris
[3] INRAE: Institut national de recherche pour l’agriculture, l’alimentation et l’environnement
[4] Routy B. et al, Science 2018, Matson et al, Science 2018, Gopalakrishnan V. et al, Science, 2018
[5] Davar D. et al, Science, 2021 ; Baruch E.N. et al, Science, 2021
About MaaT013
MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donor, Microbiome Ecosystem Therapy. It is characterized by a consistently high diversity and richness of microbial species and the presence of ButycoreTM (group of bacterial species known to produce anti-inflammatory metabolites). MaaT013 aims to restore the symbiotic relationship between the patient’s functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and thus reduce steroid-resistant, gastrointestinal-predominant aGvHD. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for acute Graft-versus-Host Disease (aGvHD) and is currently being evaluated in a Phase 3 clinical trial. MaaT Pharma has obtained positive safety and efficiency clinical data for 76 patients with aGvHD (Phase 2 clinical trial and Early Access Program in France).