On November 6, 2026 MaaT Pharma (EURONEXT: MAAT – the "Company"), a late-stage clinical biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported an update on the preliminary findings from the Phase 2a PICASSO clinical trial, an investigator-sponsored study conducted by AP-HP in collaboration with INRAe and Gustave Roussy evaluating MaaT013 (Xervyteg) in combination with immune checkpoint inhibitors (ipilimumab and nivolumab) in patients with advanced, unresectable or metastatic melanoma who had not previously received anti-CTLA-4, anti-PD-1 or anti-PD-L1 therapy.

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This communication follows the publication of study information in the EU Clinical Trials Information System (CTIS), as submitted by the PICASSO investigators. The findings reported here are derived exclusively from this CTIS disclosure and should not be considered a final scientific publication of the study results. Full results and analyses will be presented by the PICASSO investigators at a future scientific congress. Preliminary results are available here in CTIS.

Preliminary findings, based on currently available data extracted from the CTIS submission:

The study met its primary objective of assessing the safety and feasibility of adding MaaT013 (Xervyteg) to ipilimumab and nivolumab in treatment-naïve metastatic melanoma. No statistically significant difference was observed in the incidence of Grade 3 or higher adverse events between the two treatment arms.
Based on the currently available data, the safety profile observed with MaaT013 (Xervyteg) in combination with ipilimumab and nivolumab was generally consistent with the expected safety profile of the immunotherapy combination.
Response rates, a main secondary endpoint, were comparable in the MaaT013 (Xervyteg) and placebo arms and consistent with previously reported response rates for ipilimumab and nivolumab combination therapy.
Additional secondary endpoints were also assessed, including longitudinal microbiome and biomarker analyses.
Exploratory analyses suggest that baseline microbiome composition (i.e.: before treatment) may influence clinical response to MaaT013 (Xervyteg), warranting further investigation.
Treatment with MaaT013 (Xervyteg) was associated with significant increases in microbiome richness and diversity compared to placebo, confirming an effect of MaaT013 (Xervyteg).

"PICASSO provides important safety and feasibility-controlled data on the administration of a microbiome therapy in combination with immune checkpoint inhibitors," said Hervé Affagard, Chief Executive Officer and co-founder of MaaT Pharma. "These findings provide further insight into the importance of treatment setting and patient selection. Together with the planned microbiome analyses, they will help inform the immuno-oncology strategy as we continue to advance MaaT034 development in ICI-refractory patients."

A total of 70 patients were randomized across five centers in France. The analysis included 69 patients, with 34 patients in the MaaT013 (Xervyteg) arm and 35 patients in the placebo arm. The Company provided MaaT013 (Xervyteg) and placebo and generated shotgun metagenomic profiles of patients using its proprietary gutPrint research engine. The PICASSO trial (ClinicalTrials.gov: NCT04988841 and CTIS / EU Clinical Trial (EU CT) number: 2024-516100-42-00) is fully 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).

(Press release, MaaT Pharma, NOV 6, 2026, View Source [SID1234674393])