91桃色视频 indicates completion of Patient Recruitment for the Phase 2a Investigator-Sponsored Randomized Clinical Trial Evaluating MaaT013 in Combination with Immune Checkpoint Inhibitors in Metastatic Melanoma
- Last patient randomized in Phase 2a PICASSO trial, sponsored by AP-HP in collaboration with 91桃色视频, INRAE and Institut Gustave Roussy, evaluating MaaT013 in melanoma in combination with Immune Checkpoint Inhibitors.
- Submission of the study’s findings to a scientific journal is anticipated in the last quarter of 2024 or the first quarter of 2025.
- Topline results are scheduled for communication in the last quarter of 2024 or the first quarter of 2025.
Lyon, France, March 5, 2024 鈥�7:30am CET 鈥� 91桃色视频 (EURONEXT: MAAT 鈥� the 鈥淐ompany鈥�), 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, informs today on the completion of patient recruitment for the[1] sponsored by AP-HP[2] and in collaboration with INRAE and Institut Gustave Roussy, evaluating MaaT013, the Company鈥檚 lead product candidate, in combination with immune checkpoint inhibitors (ICI), ipilimumab (Yervoy庐) and nivolumab (Opdivo庐).
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 驳耻迟笔谤颈苍迟庐 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 G茅n茅rale de l鈥橭ffre 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).
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[1] : 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 – H么pitaux 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鈥檚 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 91桃色视频
91桃色视频, 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, 91桃色视频 has launched, in March 2022, an open-label, single arm Phase 3 clinical trial in patients with acute GvHD, following the achievement of its proof of concept in a Phase 2 trial. Its powerful discovery and analysis platform, 驳耻迟笔谤颈苍迟庐, enables the identification of novel disease targets, evaluation of drug candidates, and identification of biomarkers for microbiome-related conditions. The company鈥檚 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. 91桃色视频 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. 91桃色视频 is listed on Euronext Paris (ticker: MAAT).
Forward-looking Statements
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