MaaT Pharma Eyes FDA Meeting, Advances Cancer Drug MaaT034 for Solid Tumors

S. Food and Drug Administration, focused on CMC (Chemistry, Manufacturing, and Controls), is scheduled for October 2026 and marks the next key regulatory milestone for MaaT034. The company said a first-in-human study has been designed to identify the optimal dosing and pre-treatment regimen and to generate initial clinical proof-of-concept data. Initial clinical development is 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.

MaaT Pharma said the first-in-human study could begin in late 2027, subject to obtaining the appropriate funding and necessary regulatory clearance. MaaT Pharma said it has set a Pre-IND CMC-focused meeting with the FDA for October 2026, marking the next regulatory step toward clinical development of MaaT034. The company said MaaT034, its first functionally selected, co-cultured microbial ecosystem from the donor-independent MET-C platform, is to be evaluated with PD-(L)1 inhibitors in advanced solid tumors.

MaaT Pharma said the 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. It said MaaT034 is designed to optimize intestinal microbiome functions and support antitumor immune responses in combination with immune checkpoint inhibitors. The program’s move toward clinical development follows preclinical findings presented at the AACR and SITC Annual Meetings(1).

MaaT034 is being developed for use 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 with significant unmet medical needs and limited treatment options. By modulating the gut microbiome, the drug is intended to help restore anti-tumor immunity and sensitivity to PD-(L)1 inhibitors, with the goal of overcoming acquired resistance and improving outcomes beyond current standard of care benchmarks. If the necessary regulatory clearances are obtained and appropriate funding is available, MaaT Pharma could start a First-in-Human study of MaaT034 in late 2027.

To support development of MaaT034, the company is seeking financing from investors and strategic partnerships with pharmaceutical companies. MaaT Pharma says it is a late-stage clinical company focused on gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. The company was founded in 2014 and is based in Lyon, France. MaaT Pharma said it is preparing for a meeting with the FDA and is advancing MaaT034, a cancer drug candidate for solid tumors.

MaaT034 is in preclinical development and is described as a donor-independent, functionally selected, co-cultured microbial ecosystem designed to improve patient responses to immunotherapy when used with Immune Checkpoint Inhibitors (ICIs). The candidate was developed with MaaT Pharma’s proprietary MET-C co-culturing platform and is intended for large-scale manufacturing. Preclinical data presented at the AACR and at SITC annual meetings showed MaaT034 produced key metabolites linked to gut barrier restoration and immune modulation, including Short-Chain Fatty Acids (SCFA), secondary bile acids and tryptophan derivatives.

MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021. MaaT034 is intended to restore microbiome-mediated functions, modulate immune responses and complement the mechanism of action of immune checkpoint inhibitors in patients with advanced solid tumors. The company says the candidate may enhance T-cell activation and increase anti-tumor activity when combined with anti-PD-1 or anti-PD-L1 therapies. MaaT Pharma also noted that all statements other than historical facts in the release are subject to change without notice and to factors beyond the company’s control.

The company said such forward-looking statements include, without limitation, words such as “target,” “believe,” “expect,” “aim”, “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and similar terms, or the negative thereof. It added that forward-looking statements are subject to inherent risks and uncertainties beyond the company’s control that could cause actual results or performance to differ materially from expected results or performance. Forward-looking statements in this release are subject to the usual risks and uncertainties.

(1) Preclinical data on MaaT034 have been presented at the AACR and SITC annual meetings since 2023. Posters are available in the dedicated section of the company’s website. com. com.