On November 7, 2024 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported that updated results from its Early Access Program of MaaT013 in 154 patients with steroid-refractory (SR) or dependent (SD) gastrointestinal acute Graft-versus-Host Disease (GI-aGvHD) have been selected for poster presentation at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, MaaT Pharma, NOV 7, 2024, View Source [SID1234647851]). GI-aGvHD is a major cause of morbidity and mortality following allogeneic hematopoietic stem cell transplantation. These patients previously failed 1 to 6 aGvHD systemic treatment lines and most had grade III (47%) or IV (40%) aGvHD.

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Robust response rates that translated in sustained survival and strong safety were observed following MaaT013 treatment, confirming its potential as a transformative therapy for GI-aGVHD patients in urgent need of novel therapies.

Efficacy data is summarized below (see here for full abstract):

Full patient cohort (n=154):

The gastrointestinal overall response rate (GI-ORR) at day 28 was 51% with complete response (CR) occurring in 46 patients (30%). ORR considering all organs was 49% with CR occurring in 41 patients.
Overall survival (OS) was 53% at 6 months, 47% at 12 months and 42% at 24 months, indicating long-term benefits survival. Importantly, OS was significantly higher in patients who responded to MaaT013 compared to non-responders (68% versus 24% at 12 months and 58% versus 24% at 24 months).
Subset receiving 2nd line ruxolitinib (n=58) resembling the population enrolled in the Phase 3 ARES trial:

Compared to the full patient cohort, improved responses were observed. The GI-ORR was 59% at day 28 (CR 48%). ORR considering all organ was 55% (CR 43%).
In line with the full patient cohort, OS was significantly higher in patients who responded to MaaT013 compared to non-responders (75% versus 11% at 12 months and 61% versus 11% at 24 months).
As a reminder, historical data from Abedin et al. 2021 publication demonstrate that in third-line GI-aGvHD, overall survival rates are critically low: 20% at 6 months, 15% at 12 months, and only 10% at 18 months.

"As we eagerly anticipate the forthcoming results of our Phase 3 ARES trial, we are encouraged by these positive long-term results which underscore MaaT013’s potential to address a significant unmet need for patients with refractory GI-aGvHD," said Dr. Gianfranco Pittari, MD PhD, Chief Medical Officer of MaaT Pharma. "The significant survival benefit conferred by MaaT013 reaffirm our commitment to advancing this novel microbiome-based approach, which we believe could become a game-changer in the treatment of aGvHD."

The Company will host an investor webcast to discuss the data following poster presentation, further details will be announced in the coming days.

Details of the presentation:

Title: Pooled Fecal Allogenic Microbiotherapy for Refractory Gastrointestinal Acute Graft-Versus-Host Disease: Results from Early Access Program in Europe
Poster number: 4903
Presenter: Professor Florent Malard, hematology professor at the Saint-Antoine Hospital and Sorbonne University
Session: Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster III
Session Date/Time: Monday, December 9, 2024: 6:00pm -8:00pm EST
Location: San Diego Convention Center, Halls G-H
Upcoming investor and medical conferences participation

November 6-8, 2024 – 39th SITC (Free SITC Whitepaper) annual meeting in Houston, USA
November 20-22, 2024 – SFGM-TC annual meeting in Toulouse, France
November 25-27, 2024 – Deutsches Eigenkapitalforum annual meeting​​ in Frankfurt, Germany
November 26, 2024 – Investir Day event in Paris, France.
December 5, 2024 – CF&B Midcap Events in Geneva, Switzerland
December 7-10, 2024 – 66th ASH (Free ASH Whitepaper) annual meeting in San Diego, USA, followed by a webinar on the updated dataset from the EAP of MaaT013 in aGvHD.