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MaaT Pharma Receives FDA Feedback Following Pre-IND Meeting Supporting Continued Development of MaaT034 in Solid Tumors

Business Wire

  • Positive pre-Investigational New Drug (pre-IND) interaction with the Food Drug Administration (FDA) on Chemistry, Manufacturing and Controls (CMC) and nonclinical topics supports MaaT034's continued advancement

  • FDA alignment on the IND-enabling strategy indicates that no additional non-clinical studies are anticipated to be required to support the safety of MaaT034 administration

LYON, France, October 19, 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, announced productive and constructive feedback from the U.S. FDA following its pre-IND interaction for MaaT034 in potential solid tumor indications including Non-Small Cell Lung Cancer, Melanoma and Renal Cell Carcinoma, focused on CMC and nonclinical development.

Based on the information provided, and pending the receipt and confirmation of the FDA's final meeting summary, the FDA indicated that MaaT Pharma's proposed science- and risk-based development approach appears appropriate, subject to review of the complete IND submission. The FDA also indicated that no additional nonclinical studies are required to support the safety of MaaT034 administration. The FDA requested additional information from completed studies for inclusion in the IND submission.

"The positive outcome of our pre-IND interactions with the FDA reinforces the development pathway for MaaT034 and supports its continued advancement toward the clinic. It also represents an important step in MaaT Pharma's expansion into immuno-oncology, highlighting the broader potential of our first in class co-cultivated microbiome donor-independent platform across cancer care," said Hervé Affagard, CEO and co-founder of MaaT Pharma.

MaaT Pharma plans to continue its IND-enabling activities and further engage with the FDA through a Type C meeting focused on the proposed clinical development plan and first-in-human study design.

Subject to obtaining the necessary regulatory clearances and the availability of appropriate funding and taking into account the Company's estimated cash runway to December 2026, MaaT Pharma could initiate a First-in-Human study evaluating MaaT034 in late 2027. To support the clinical development of MaaT034, the Company is exploring financing opportunities from investors and strategic partnerships.

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About MaaT Pharma
MaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France. As a pioneer, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021.

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