MaaT Pharma Presents Positive 18-month Data for MaaT013 Showing a Clear Overall Survival Advantage in aGvHD from the Early Access Program at the 2024 EBMT Event

Regulatory News:

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, presents a summary of its oral presentation at the 50th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) currently being hosted in Glasgow, Scotland from 14-17 April 2024. The presentation is scheduled for April 17^th by Dr. Malard, Professor of Hematology at Saint-Antoine Hospital and Sorbonne University in Paris and is based on the abstract made available on the website of the event.

This presentation will unveil promising extended outcomes from the EAP in Europe, involving 140 patients with steroid-refractory (SR) or steroid-dependent (SD) gastrointestinal acute graft-versus-host disease (GI-aGvHD) treated with MaaT013. Prof. Malard will emphasize a significantly high response rate (Complete Response [CR] and Very Good Partial Response [VGPR]) to MaaT013, demonstrating a clear reduction in disease burden and improved Overall Survival (OS) at 18 months compared to published data.

Prof. Malard commented: “MaaT013 shows remarkable efficacy at 18 months, yielding more complete responses in aGvHD patients who have shown resistance to current treatments, as compared to other available therapies. This effect is coupled with reduced toxicity compared to standard immunosuppressive drugs. Notably, these results are achieved with just 3 doses in less than 2 weeks of treatment initiation. This would not only improve patient outcomes, but also significantly enhance their quality of life.”

Echoing this feedback, Dr. Jaime Sanz Caballer, Hematologist and coordinator of the Bone Marrow Transplant Unit at the University Hospital La Fe in Valencia, Spain, also commented: “there is a persistent unmet medical need in aGvHD with consistently reported poor survival outcomes. This is particularly noticeable for patients in third-line treatment options where only 15% of patients survive at 12 months¹. This underscores the urgent demand for innovative solutions such as MaaT013, presenting a promising immuno-restorative approach."

The data presented highlights the strong safety profile of MaaT013 (full details here) and translates into increased OS. In this heavily pre-treated population (n=140), the following results were observed:

• GI-ORR of 52% at D28, with CR observed in 28% of patients; ORR considering all organs was 52% with 24% CR.
• OS was 54% at 6 months, 47% at 12 months, 42% at 18 months.
• 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 18 months).

A subset of the 140 patients (n=49) that is a similar population to that of the ongoing Phase 3 ARES clinical trial (NCT04769895): steroid- and ruxolitinib- refractory corresponding to the third-line treatment demonstrated even better efficacy: