On March 7, 20222 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 that positive results from its Phase 2 trial HERACLES (NCT03359980, n=24) and from its compassionate use program (EAP, n=52) for lead microbiome therapy MaaT013 will be reported in an oral presentation at the 48th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT 2022) held as an online event from March 19th to March 23rd, 2022 (Press release, MaaT Pharma, MAR 17, 2022, View Source [SID1234610265]).
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The data, previously presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2021, showed that MaaT013 treatment in patients that developed GI-aGvHD following hematopoietic cell transplantation demonstrated promising objective gastro-intestinal response rate (GI-ORR) in both groups. The observed GI-ORR with MaaT013 treatment at day 28 was 38% in the HERACLES trial, including 5 complete responses (21%), and 58% in the EAP patients, including 17 complete responses (33%). The 12-month overall survival in patients who responded to treatment was 44% in HERACLES and 59% in the EAP program.
Results will be live-streamed and presented by Dr. Florent Malard, Associate Professor of Hematology at the Saint-Antoine Hospital and Sorbonne University, who participated in the HERACLES clinical trial.
Oral Presentation details (virtual live session):
Title: Pooled Allogenic Fecal Microbiotherapy MaaT013 for the Treatment of Steroid-Refractory Gastrointestinal Acute Graft-Versus-Host Disease: Results from the Phase 2a Heracles Study and Expanded Access Program
Abstract number: OS10-06
Session Name: OS10 Oral session 10: GVHD I, clinical
Date/Time: Wednesday, March 23, 9:45 am – 9:54 am CET
Link to register: View Source
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. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for its development in treating acute Graft-versus-Host Disease (aGvHD).