On March 5, 2024 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 the completion of patient recruitment for the Phase 2a clinical trial[1] sponsored by AP-HP[2] 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) (Press release, MaaT Pharma, MAR 5, 2024, View Source [SID1234640784]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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).
[1] NCT04988841: Prospective randomIzed clinical trial assessing the tolerance and clinical benefit of feCAl tranSplantation in patientS with melanOma treated with CTLA-4 and PD-1 inhibitors.
[2] AP-HP: Assistance Publique – Hôpitaux de Paris
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).