LYON, France — MaaT Pharma (EURONEXT: MAAT), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival of patients with cancer, informs today on the completion of patient recruitment for the Phase 2a clinical trial sponsored by AP-HP and in collaboration with INRAE and Institut Gustave Roussy, evaluating MaaT013, the Company’s lead product candidate, in combination with immune checkpoint inhibitors (ICI), ipilimumab (Yervoy®) and nivolumab (Opdivo®).
A total of 70 patients have been enrolled in 5 different centers in France in the randomized controlled Phase 2a PICASSO trial, which started in April 2022. The Company provided MaaT013 drug candidate and placebo and will contribute to the microbiome profiling of patients using its proprietary gutPrint® research engine. The unblinding will be done at Week 27 (W27) to assess the primary endpoint which is safety. In parallel, the first efficacy data will be made available, assessed by the best overall response rate, rated by immunological Response Evaluation Criteria in Solid Tumors (iRECIST; 19).
Having reached this key recruitment milestone, the first publication will be submitted at the end of 2024 or in the first quarter of 2025.
The PICASSO trial is funded by the Directorate of Health Care Supply (DGOS: Direction Générale de l’Offre de Soins) and operated by the French National Cancer Institute (INCa: Institut National du Cancer) as part of a call for projects (project PHRC-K19-183).
About MaaT013
MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donor, enema Microbiome Ecosystem TherapyTM for acute, hospital use. It is characterized by a consistently high diversity and richness of microbial species and the presence of ButycoreTM (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, gastrointestinal (GI)-predominant aGvHD. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
About MaaT Pharma
MaaT Pharma, a clinical stage biotechnology company, has established a complete approach to restoring patient-microbiome symbiosis in oncology. Committed to treating cancer and graft-versus-host disease (GvHD), a serious complication of allogeneic stem cell transplantation, MaaT Pharma launched, in March 2022, an open-label, single arm, phase 3 clinical trial in patients with acute GvHD (aGvHD), following the achievement of its proof of concept in a phase 2 trial. Its powerful discovery and analysis platform, gutPrint®, enables the identification of novel disease targets, evaluation of drug candidates, and identification of biomarkers for microbiome-related conditions. The company’s Microbiome Ecosystem Therapies are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome, in liquid and oral formulations. MaaT Pharma benefits from the commitment of world-leading scientists and established relationships with regulators to support the integration of the use of microbiome therapies in clinical practice.
Contacts
MaaT Pharma – Investor Relations
Guilhaume DEBROAS, Ph.D.
Head of Investor Relations
+33 6 16 48 92 50
[email protected]
MaaT Pharma – Media Relations
Pauline RICHAUD
Senior PR & Corporate Communications Manager
+33 6 14 06 45 92
[email protected]
Trophic Communications
Stephanie MAY or
Priscillia PERRIN
+49 151 7441 6179
[email protected]