We are delighted to share that the ANSM has approved the start of part 2 for the BIG trial, the world’s largest phase 2 randomized trial evaluating a microbiome-based approach in oncology.

The BIG trial (NCT0625361) led by the outstanding team at GERCOR, will look to enroll additional patients to receive EXL01, our novel NOD2-targeting biotherapeutic, in combination with nivolumab and folfox. The trial aims to assess the efficacy and durability of patient response to the treatment.

EXL01 is designed to reprogram macrophages and enhance checkpoint inhibitor efficacy with the goal of improving both the efficacy and durability of response in first-line gastric cancer. If successful, this trial could help set a new standard of care and reinforce the potential of microbiome-based approaches to oncology treatment.

Interim analysis is due in the second half of 2026 with final results expected in 2027, so watch this space for more updates as the trial progresses!

More information on this trial (NCT0625361) can be found on clinicaltrial.gov

‍