pipeline

EXL01 — A First-in-Class Innate Immunotherapy in Clinical Development

Through selective activation of the NOD2–CARD9 pathway, EXL01 aims to enhance the efficacy and durability of immune checkpoint inhibitors while also enabling therapeutic activity across other immune-related diseases.

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Learn more about F. praustnizii in Inflammatory Bowel Diseases

Oncology: Enhancing the Efficacy of Cancer Immunotherapy

Many tumors remain resistant to immune checkpoint inhibitors (ICIs) because the innate immune system fails to properly activate anti-tumor T-cell responses.

EXL01 addresses this bottleneck by reprogramming immunosuppressive macrophages into pro-inflammatory, tumor-fighting cells through activation of the NOD2–CARD9 pathway.

‍By restoring this innate–adaptive immune axis, EXL01 aims to increase the depth and durability of responses to checkpoint inhibitors.

Lead Program: First-Line Advanced Gastric Cancer

The lead development program for EXL01 is the BIG randomized Phase 2 clinical trial (NCT06253611 - Sponsored by GERCOR) evaluating EXL01 in combination with nivolumab and chemotherapy in first-line advanced gastric cancer.

Gastric cancer remains a major global health challenge, and many patients fail to achieve durable responses with current immunotherapy combinations.

The BIG study evaluates whether EXL01 can enhance checkpoint inhibitor efficacy by restoring upstream innate immune activation.

Key study parameters
‍• Randomized Phase 2 trial
• 120 patients
• Combination with nivolumab + FOLFOX
• Primary endpoint: Objective Response Rate
• Secondary endpoints: PFS, OS, safety
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Expanding the Oncology Footprint

NCT06448572 - EXL01 in Combination With Nivolumab for Advanced NSCLC Refractory to Immunotherapy. (EXLIBRIS)  
– Sponsored by CHU Lille – Recruiting 
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NCT06551272 - Microbiota Modification for Immuno-oncology in Hepatocellular Carcinoma (MOTHER)  
– Sponsored by Centre Eugène Marquis - Recruiting 
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A randomized pilot study of nivolumab and ipilimumab with and without Exl01 in first-line treatment of metastatic renal cell carcinoma (mRCC)
– IND submission planned in 2Q2025

EXL02

EXL02 is a pre-clinical Live Biotherapeutic candidate leveraging the properties of another gut bacteria, with a focus on its ability to activate the AhR-pathway.

EXL03

EXL03 is a preclinical recombinant protein candidate mimicking the properties of natural enzymes, in particular its ability to activate the Kynurenine pathway.

We would be glad to discuss partnership opportunities with you

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