The University of Chicago has dosed the first patient in an investigator-sponsored Phase 2a clinical trial evaluating an investigational drug in combination with Merck’s KEYTRUDA.® Evelo Biosciences, Inc (Nasdaq: EVLO) (Evelo) reports that its experimental EDP1503, an orally delivered monoclonal microbial product candidate for cancer is used in combination with Merck’s anti-PD-1 therapy KEYTRUDA.
An open-label clinical trial is evaluating the safety, tolerability and efficacy of EDP1503 in combination with KEYTRUDA in up to 70 patients with metastatic melanoma who are previously untreated or who have relapsed following treatment with an anti-PD-1 inhibitor.
Patients are receiving EDP1503 monotherapy for two weeks followed by treatment with daily EDP1503 in combination with KEYTRUDA. The investigators will evaluate biomarkers identified from the paired biopsies taken before and after the two-week run-in, as well as clinical outcomes observed over the course of that trial—as well as intestinal microbiome. The team expects initial clinical data from the trial in the second half of 2020. In preclinical research, EDP1503 has shown activation of multiple clinically validated systemic immune pathways which are complementary to and potentially synergistic with checkpoint inhibitors. Outcome measures can be viewed here.
Jason Luke, MD, FACPSource: www.globalnewswire.com