On November 2, 2023 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotech company and a leader 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 of MaaT013 in 111 patients (additional 30 patients included in the Program compared to last year) with aGvHD and the design of its Phase 2b study evaluating MaaT033 in improving overall survival in patients undergoing allogenic hematopoietic cell transplantation (allo-HSCT) have been selected for poster presentations at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting held from December 9-12, 2023, in San Diego, California, USA (Press release, MaaT Pharma, NOV 2, 2023, View Source [SID1234636773]). This is the seventh year in a row that the Company’s clinical data and activities have been selected for a presentation at the ASH (Free ASH Whitepaper) Annual Meeting, the world-leading event in malignant and non-malignant hematology, demonstrating the ongoing interest from clinicians for microbiome modulation approaches in the hemato-oncology field.

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In line with the conference embargo policy, MaaT Pharma will detail the presented results through a press release on Monday, December 11th, 2023. The Company will also host an investor webcast on Monday, December 18th, 2023, at 6:00pm CET (further details to follow).

The EAP results include data from 111 patients with steroid-resistant or steroid-dependent aGvHD treated with MaaT013, previously unresponsive to 1-6 lines of therapy. MaaT013 is currently being evaluated in a pivotal Phase 3 trial (n=75) for corticosteroid- and ruxolitinib-refractory gastrointestinal aGvHD. The Company shared the positive review by DSMB in October 2023 for this Phase 3 trial, including a favorable benefit/risk ratio, with a good safety profile and positive preliminary efficacy results. As of today, over 170 patients have been safely treated with MaaT013 in Europe in clinical trials and the EAP.

The Company provides an update on MaaT033, an oral ecosystem microbiome capsule for adjunctive therapy, and will share the design of the Phase 2b trial, the largest randomized clinical trial (RCT) study for a microbiome therapy in hemato-oncology to date with the enrollment of 387 patients, investigating the efficacy of MaaT033 in improving overall survival for patients receiving allo-HSCT.

Poster Presentations:

MaaT013

Title: Pooled Fecal Allogenic Microbiotherapy for Refractory Gastrointestinal Acute Graft-Versus-Host Disease: Results from Early Access Program in Europe
Poster number: 3553
Presenter: Professor Florent Malard, hematology professor at the Saint-Antoine Hospital and Sorbonne University
Session: Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster II
Session Date/Time: Sunday, December 10, 2023: 6:00pm -8:00pm EST
Location: San Diego Convention Center, Halls G-H
MaaT033

Title: A Multicentre, Randomized, Double-Blinded, Phase 2b Study Evaluating the Efficacy and Safety of MaaT033, an Oral, Pooled Microbiome Ecosystem Therapy in Patients Undergoing Allogenic Hematopoietic Cell Transplantation to Improve Overall Survival: The Phoebus Trial
Poster number: 4947
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 11, 2023: 6:00pm -8:00pm EST
Location: San Diego Convention Center, Halls G-H
Upcoming scientific conference participations

November 1-5, 2023 – 38th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting – Posters presentations
November 15-17, 2023 – 22nd Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) Congress – Booth #12
December 9-12, 2023 – 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting- Posters presentations