On November 3, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported that extended results from its Early Access Program (EAP) of MaaT013 in patients with GI-aGvHD have been selected for oral presentation at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting held from December 10-13, 2022, in New-Orleans, Louisiana, U.S.A (Press release, MaaT Pharma, NOV 3, 2022, View Source [SID1234622950]). Additionally, detailed results of the Phase 1b trial of MaaT033 in patients with acute myeloid leukemia (AML) were selected for presentation in a poster session. This is the sixth year in a row that the Company’s clinical data are selected for presentation at the ASH (Free ASH Whitepaper) Conference, the world-leading event in malignant and non-malignant hematology, and the third year in a row for an oral presentation.
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In line with the conference embargo policy, MaaT Pharma will detail the presented results through a press release on Saturday, December 10, 2022. The Company will also host an investor webcast on Monday, December 12th, 2022, at 6:00pm CET (additional details will be provided at a later date).
The EAP results include data from 81 patients treated with MaaT013, with steroid-resistant or steroid-dependent aGvHD with GI involvement, who had previously failed 1 to 6 lines (median: 2) of systemic therapy; MaaT Pharma provided the MET product to hospitals under a compassionate access program in France. In parallel, MaaT013 is currently being evaluated in a pivotal open-label, single-arm Phase 3 trial in Europe (n=75) in GI-aGvHD patients refractory to corticosteroids and ruxolitinib; a first data review is expected in the first half of 2023. As of today, MaaT013 has been safely administered to more than 160 patients in Europe in clinical trials and in the Expanded Access Program in France.
Oral Presentation:
Title: Pooled Fecal Allogenic Microbiotherapy for Refractory Gastrointestinal Acute Graft-Versus-Host Disease: Results from the Early Access Program in France
Presenter: Professor Mohamad Mohty, hematology professor and Head of the Hematology and Cellular Therapy Department at the Saint-Antoine Hospital and Sorbonne University
Publication Number: 112
Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Clinical Studies Exploring the Immunobiology of HCT
Session Date/Time: Saturday, December 10, 2022; 10:15am EST
Room: 252-254 (Ernest N. Morial Convention Center)
Poster:
Title: Restoration Of Gut Microbiota Diversity With Oral Pooled Fecal Microbiotherapy In Acute Myeloid Leukemia Patients After Intensive Chemotherapy: The Phase 1b CIMON Trial
Presenter: Professor Mohamad Mohty, hematology professor and Head of the Hematology and Cellular Therapy Department at the Saint-Antoine Hospital and Sorbonne University
Poster number: 2765
Session: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies
Session Date/Time: Sunday, December 11, 2022: 6:00pm -8:00pm EST
Room: Hall D (Ernest N. Morial Convention Center)
Upcoming scientific conferences participations
November 8-10, 2022 – 9th International Human Microbiome Consortium (IHMC) Congress: Poster and oral presentation
November 9-11, 2022 – 21st Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) Congress – Booth #10 – poster and oral presentation
December 10-13, 2022 - 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting: Poster and oral presentation
About MaaT013
MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donor, enema Microbiome Ecosystem TherapyTM for acute, hospital use. 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).
About MaaT033
MaaT033 is an oral, full-ecosystem, off-the-shelf, standardized, pooled-donor, high-richness Microbiome Ecosystem TherapyTM. MaaT033 is designed to restore the gut ecosystem to full functionality to improve clinical outcomes as well as to control adverse events related to conventional treatments for liquid tumors. The capsule formulation facilitates administration and allows the potential to treat larger patients’ population while maintaining the high and consistent richness and diversity of microbial species, including anti-inflammatory ButycoreTM species.