91桃色视频 Receives FDA Feedback Following Pre-IND Meeting Supporting Continued Development of MaaT034 in Solid Tumors
- 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鈥檚 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
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Lyon, France, October 19, 2026 – 6:30pm CET听鈥� 91桃色视频 (EURONEXT: MAAT 鈥� the 鈥淐ompany鈥�), 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鈥檚 final meeting summary, the FDA indicated that 91桃色视频鈥檚 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.
鈥淭he 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 91桃色视频鈥檚 expansion into immuno-oncology, highlighting the broader potential of our first in class co-cultivated microbiome donor-independent platform across cancer care,鈥� said Herv茅 Affagard, CEO and co-founder of 91桃色视频.
91桃色视频 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鈥檚 estimated cash runway to December 2026, 91桃色视频 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 91桃色视频
91桃色视频 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.听As a pioneer, 91桃色视频 is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, 91桃色视频 develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. 91桃色视频 has been listed on Euronext Paris (ticker: MAAT) since 2021.
About MaaT034
MaaT034, currently in preclinical development, is a next-generation donor-independent functionally selected, co-cultured microbial ecosystem, designed to improve patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors (ICIs). Developed using 91桃色视频鈥檚 proprietary MET-C co-culturing platform, MaaT034 is optimized for large-scale manufacturing and designed to deliver key microbial functions associated with anti-tumor immune responses.
Preclinical data presented at the AACR and at SITC annual meetings demonstrated that MaaT034 produced key metabolites, recognized as promoting gut barrier restoration and modulating immune responses, such as Short-Chain Fatty Acids (SCFA), secondary bile acids, and tryptophan derivatives. These data support the potential of MaaT034 to promote gut barrier restoration, enhance T-cell activation, and increase anti-tumor activity when combined with anti-PD-1 or anti-PD-L1 therapies.
By restoring microbiome-mediated functions and modulating immune responses, MaaT034 is designed to complement the mechanism of action of immune checkpoint inhibitors and has the potential to improve treatment outcomes in patients with advanced solid tumors.
Forward-looking Statements
All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company鈥檚 control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as 鈥渢arget,鈥� 鈥渂elieve,鈥� 鈥渆xpect,鈥� 鈥渁im鈥�, 鈥渋ntend,鈥� 鈥渕ay,鈥� 鈥渁nticipate,鈥� 鈥渆stimate,鈥� 鈥減lan,鈥� 鈥減roject,鈥� 鈥渨ill,鈥� 鈥渃an have,鈥� 鈥渓ikely,鈥� 鈥渟hould,鈥� 鈥渨ould,鈥� 鈥渃ould鈥� and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company鈥檚 control that could cause the Company鈥檚 actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.
