We’re very pleased to announce that the pre-specified futility analysis defined in the BIG protocol is positive!

Under the protocol, this result allows full patient recruitment to continue without modification.

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BIG is a 120-patient randomized Phase 2 study in first-line advanced gastric cancer, evaluating EXL01 (our innate immune conditioner) as an add-on to nivolumab (anti-PD-1) + Folfox (chemotherapy), with patients randomized 2:1. The primary endpoint of the study is the Objective Response Rate at 4 months.

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BIG is sponsoredby GERCOR and is among the largest randomized clinical studies globally in its field. The study remains on track toward its primary endpoint readout in 2028.

Running an investigator-sponsored Phase 2 in a complex oncology indication is operationally demanding. This milestone reflects the dedication and execution quality of the PI (Pr. Romain Cohen), the GERCOR team and network, and all clinical teams involved.

Congratulations to Adeline Feri, to Mathilde Delaunay and to the entire Exeliom and GERCOR teams for reaching this milestone and taking EXL01 that far!

We will continue sharing updates as the program advances.

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More information on the BIG study here: https://clinicaltrials.gov/study/NCT06253611?term=EXL01&viewType=Card&rank=7

Moreinformation on EXL01 here: https://www.exeliombio.com/

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