Evelo, Merck Enter Clinical Trial Collaboration

Evelo Biosciences has entered into a clinical trial collaboration agreement with Merck. The collaboration will evaluate EDP1503 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in multiple cancer indications. EDP1503 is an orally delivered monoclonal microbial product candidate being developed for the treatment of cancer.

The planned Phase 1/2 trial will evaluate the safety, tolerability, immune response markers and overall response rates (ORRs) achieved with EDP1503 in combination with KEYTRUDA® (pembrolizumab) in three groups of patients: micro-satellite stable colorectal cancer; triple-negative breast cancer; and patients across multiple tumor types who have relapsed on prior PD-1/L1 inhibitor treatment. Evelo expects to commence this clinical trial in the first half of 2019 and plans to enroll up to 120 patients in this non-comparative, single-arm, multicenter clinical study.

‘’We are very pleased to collaborate with Merck, one of the world leaders in immuno-oncology, in our clinical investigation of EDP1503 in combination with Keytruda®. We have shown preclinically that oral delivery of EDP1503 activates multiple systemic immune pathways across clinically validated mechanisms of tumor immune stimulation which are complementary to and potentially synergistic with checkpoint inhibitors," said Humphrey Gardner, M.D., FCAP, chief of medical oncology at Evelo. "These immune-activation properties of EDP1503, including upregulation of MHC Class I expression, increased production of CXCL9 and CXCL10, and augmentation of NK cell infiltration point to the potential to offer a treatment approach in tumors that have, to date, proved unresponsive to checkpoint inhibitor monotherapy, such as microsatellite stable colorectal cancer."

EDP1503 is currently being evaluated in an investigator-sponsored Phase 2a clinical trial in combination with KEYTRUDA® in patients with metastatic melanoma. First patient dosing in this study is expected by the end of 2018.

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