On October 19, 2026 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, reported 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.
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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.
(Press release, MaaT Pharma, OCT 19, 2026, View Source [SID1234673558])