Regulatory Filings • Dec 10, 2024
Regulatory Filings
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Lyon, France, December 10th, 2024 1:00am CET - MaaT Pharma (EURONEXT: MAAT - the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies™ (MET) dedicated to enhancing survival for patients with cancer through immune modulation, announced that Prof. Malard, MD, hematology professor at Saint-Antoine Hospital and Sorbonne University, today 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) Annual Meeting.
Speaking on the data, Florent Malard, MD, PhD, highlighted: "These findings undersore 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'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
Subset (n=58) resembling the population enrolled in the Phase 3 ARES trial (receiving 2ª line ruxolitinib):
Full details on data available here.
MaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France.
As a pioneer, MaaT Pharma is leading the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021.

MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donor, enema Microbiome Ecosystem Therapy™ for acute, hospital use. It is characterized by a consistently high diversity and richness of microbial species and the presence of Butycore™ (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 (GI)-predominant aGvHD. Mas been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Acute Graft-versus-Host Disease occurs in patients within 100 days of undergoing a stem cell or bone marrow transplant. The transplanted cells attack the recipient, causing inflammation of the skin, liver and/or gastro-intestinal tract. Gl-aGvHD results in patients experiencing very high volumes of diarrhea which can be life-threatening. The standard first line therapy for treating aGvHD is the use of systemic steroids. If patients do not respond to steroids, they are considered Steroid Resistant (SR) and other agents can be administered. Currently the only agent approved for treating SR aGvHD after failure of steroid treatment is ruxolitinib, which is currently approved for this indication in USA and has received approval from the European Medical Agency's Committee for Human Medicinal Products (CHMP) on March 25, 2022.
All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company's control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as "target," "aim", "intend," "may," "anticipate," "plan," "project," "will," "can have," "likely," "should," "could," "could" and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that could cause the Company's actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.
Guilhaume DEBROAS, Ph.D. Head of Investor Relations +33 6 16 48 92 50 [email protected]
Senior PR & Corporate Communications Manager +33 6 14 06 45 92 [email protected]
Heather Shea Media relations for MaaT Pharma +1 617-286-2013 [email protected]
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