MaaT Pharma Announces Upcoming Pre-IND Meeting with the FDA and Advances MaaT034 Toward Clinical Development in Solid Tumors
Pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA), focused on CMC (Chemistry, Manufacturing, and Controls), is scheduled for October 2026, representing the next key regulatory milestone for MaaT034
A First-in-Human study has been designed to determine the optimal dosing and pre-treatment regimen and generate initial clinical proof-of-concept data
Initial clinical development planned in combination with PD-(L)1 inhibitors in solid tumors with high unmet medical needs and limited treatment options, including second-line advanced non-small cell lung cancer (NSCLC), refractory advanced melanoma and other solid tumors
The First-in-Human study could be initiated in late 2027, subject to obtaining the appropriate funding and necessary regulatory clearance
LYON, France, September 21, 2026--Regulatory News:
MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET), dedicated to enhancing survival for patients with cancer through immune modulation, today announced the next clinical development steps for MaaT034, the first functionally-selected, co-cultured microbial ecosystem from the Company's innovative donor-independent MET-C platform, to be evaluated in combination with PD-(L)1 inhibitors in advanced solid tumors.
The MET-C platform combines rational candidate design, artificial intelligence-enabled computational tools for functional feature selection and unique co-culture technology to produce functionally selected microbial ecosystems at an industrial scale. MaaT034 is the first candidate to emerge from this platform and is specifically designed with the objective of optimizing intestinal microbiome functions and to support antitumor immune responses in combination with immune checkpoint inhibitors.
MaaT Pharma has scheduled a Pre-IND CMC-focused meeting with the FDA in October 2026, the next regulatory milestone toward clinical development of MaaT034. The program's progression toward clinical development is based on a series of preclinical findings presented at the AACR and SITC Annual Meetings1.
MaaT034 is expected to be developed in combination with PD-(L)1 inhibitors in selected advanced solid tumors, including second-line NSCLC and refractory advanced melanoma, as well as in other solid tumors characterized by significant unmet medical needs and limited treatment options. By modulating the gut microbiome, MaaT034 is designed to help restore anti-tumor immunity and sensitivity to PD-(L)1 inhibitors, with the aim of overcoming acquired resistance and improving outcomes beyond current standard of care benchmarks.