On December 11, 2023 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported positive results from the Early Access Program (EAP) in Europe involving 111 patients with steroid-refractory (SR) or steroid-dependent (SD) gastrointestinal acute graft-versus-host Disease (GI-aGvHD) treated with MaaT013, at the 2023 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, MaaT Pharma, DEC 11, 2023, View Source [SID1234638427]).

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"GvHD remains a significant challenge and source of mortality following allogeneic HSCT," said Professor Mohty, Professor of Hematology at Sorbonne University, and head of the Clinical Hematology and Cellular Therapy Department at Saint-Antoine Hospital, Paris, France. "The clear connection between treatment response and overall survival demonstrates Microbiome Therapies as a potentially life-saving approach, particularly in patients who have failed earlier treatment lines, corticosteroids and ruxolitinib. MaaT013 introduces a novel therapeutic approach by restoring the gut microbiome ecosystem, offering a distinct immuno-restorative option that could complement standard immunosuppressive drugs, and could become a potential breakthrough for patients with limited options."

"These promising findings pave the way for advancing the treatment landscape for aGvHD, with microbiome-based innovations, especially when they achieve complete responses," said Hervé Affagard, CEO and co-founder of MaaT Pharma. "It reinforces our approach based on restoring patients’ immune systems through gut microbiome ecosystem therapies. The efficacy and safety results underscore the strong favourable benefit-risk profile for MaaT013, and we look forward to continuing to investigate MaaT013 with the aim of having it accessible globally for patients in need as soon as possible".

MaaT013 shown to have a safe profile and translates into increased overall survival:

GI-ORR of 53% at day 28, with Complete Response observed in more than two thirds of responders (35%); Overall Response Rate (ORR) considering all organs was 50% with 31% Complete Response (CR).
OS was 56% at 6 months and 47% at 12 months with a median follow up of 355 days.
OS was significantly higher in patients who responded to MaaT013 compared to non-responders (67% versus 24% at 12 months).
The Company defined a subgroup of 38 patients with similar treatment sequence to the ongoing Phase 3 ARES clinical trial, which included patients previously treated with steroids and ruxolitinib. GI-ORR was 61% at day 28, mainly driven by GI Complete Response (CR) with 58%. ORR was 54% including 51% with CR. Overall Survival (OS) in this group was 55% at 6 months and 52% at 12 months, confirming the CR as a proxy of survival at one year. OS was significantly higher in responders to MaaT013 treatment compared to non-responders (81% versus 8% at 12 months, respectively).

MaaT013, a pooled-donor microbiome ecosystem therapy, displayed a good overall tolerability and safety profile in the EAP population. As of today, MaaT013 has been administered to more than 200 patients. Full details on safety are available here. A Phase 3 trial is currently ongoing in Europe to confirm these results in ruxolitinib-refractory patients (NCT04769895) with ORR expected in mid-2024. The Company has an open-IND granted by the U.S. FDA with active discussions ongoing with potential clinical investigation sites.

MaaT Pharma also presented its ongoing Phase 2b trial design for MaaT033, its second candidate, at the 2023 ASH (Free ASH Whitepaper) Annual Meeting. Developed as an adjunctive therapy to enhance OS in HSCT (hematopoietic stem cell transplantation) and cellular therapy recipients, MaaT033 targets optimal microbiota function for a broader patient population in a chronic setting. This international, multi-centre trial (NCT05762211) is the largest randomized controlled study to date of a microbiome-based therapy in oncology, spanning up to 56 sites and enrolling 387 patients.

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