On December 9, 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 Prof. Malard, MD, hematology professor at Saint-Antoine Hospital and Sorbonne University, detailed updated data for 154 patients with acute Graft-versus-Host Disease (aGvHD) treated with MaaT013 in Early Access Program (EAP) in Europe during the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, MaaT Pharma, DEC 9, 2024, View Source [SID1234648907]).

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Speaking on the data, Florent Malard, MD, PhD, highlighted: "These findings underscore MaaT013’s potential as a transformative therapy for aGvHD, a condition with poor survival rates and limited treatment options. The high response rates and long-term survival data further validate the critical role of the gut microbiome modulation in managing aGvHD. Additionally, these results highlight the growing interest within the medical community, as demonstrated by ASH (Free ASH Whitepaper)’s dedicated symposium on the microbiome’s role in transplantation and cellular therapies."

Hervé Affagard, CEO and co-founder of MaaT Pharma, added: "The high demand from clinicians demonstrates growing adoption and trust in MaaT013. The strong real-world data from our Early Access Program not only gives us confidence as we approach Phase 3 results but also validates our immune modulation approach through microbiome-based therapies. Success in GvHD, a severe and complex immune-mediated disease, would pave the way to demonstrate the platform’s potential to address a broad range of complex immune-related diseases."

As a reminder, key findings include:

For the full cohort (154 patients) in the EAP

Durable reponse: 51% GI-ORR at Day 28 and a 44% GI-ORR at Day 56. ORR for all organs was 49% at D28 and 42% at D56.
Overall survival (OS): 53% at 6 months, 47% at 12 months, and 42% at 24 months.
Median survival follow-up: 418 days (range, 27-1644 days).
Subset (n=58) resembling the population enrolled in the Phase 3 ARES trial (receiving 2nd line ruxolitinib):

Higher response rate than the full cohort: GI-ORR was 59% at Day 28 and 54% at D56. ORR considering all organ was 55% at D28, and 56% at D56.
OS was 54% at 6 months, 49% at 12 months, and 40% at 24 months vs 15% at 12 months in published historical data (Abedin et al. Br J Haematol. 2021 Nov).