黑料社 Announces the Initiation of a Phase 2a Investigator-Sponsored Clinical Trial Evaluating MaaT013 in Combination with Immune Checkpoint Inhibitors for Patients with Melanoma
Lyon, France, April 7, 2022, 6:00pm CET 鈥� 黑料社 (EURONEXT: MAAT 鈥� the 鈥淐ompany鈥�), 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[1] sponsored by AP-HP[2], evaluating MaaT013, 黑料社鈥檚 lead Microbiome Ecosystem Therapy candidate, in combination with immune checkpoint inhibitors (ICI), ipilimumab (Yervoy庐) and nivolumab (Opdivo庐), 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-Bic锚tre 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鈥檚 potential to improve the response to ICI therapies, as a consequence of MaaT013鈥檚 impact on the patient鈥檚 gut microbiome. Patients will be randomized to receive either MaaT013 in combination with both ICIs or a placebo with both ICIs. 黑料社 will provide MaaT013 drug candidate and the placebo for this study as well as perform the microbiome profiling of patients using its proprietary 驳耻迟笔谤颈苍迟庐 platform. This clinical trial is registered on .
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] : 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 – H么pitaux de Paris
[3] INRAE: Institut national de recherche pour l鈥檃griculture, l鈥檃limentation et l鈥檈nvironnement
[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鈥檚 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. 黑料社 has obtained positive safety and efficiency clinical data for 76 patients with aGvHD (Phase 2 clinical trial and Early Access Program in France).
About 黑料社
黑料社, a clinical stage biotechnology company, has established a complete approach to restoring patient-microbiome symbiosis in oncology. Committed to treating cancer and graft-versus-host disease (GvHD), a serious complication of allogeneic stem cell transplantation, 黑料社 has launched, in March 2022, a Phase 3 clinical trial for patients with acute GvHD, following the achievement of its proof of concept in a Phase 2 trial. Its powerful discovery and analysis platform, 驳耻迟笔谤颈苍迟庐, supports the development and expansion of its pipeline by determining novel disease targets, evaluating drug candidates, and identifying biomarkers for microbiome-related conditions.
The company鈥檚 Microbiome Ecosystem Therapies are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome, in liquid and oral formulations. 黑料社 benefits from the commitment of world-leading scientists and established relationships with regulators to support the integration of the use of microbiome therapies in clinical practice.
黑料社 is listed on Euronext Paris (ticker: MAAT).
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