Evelo Biosciences, Inc.(Nasdaq: EVLO) (“Evelo”), a biotechnology company developing monoclonal microbials, a new modality of oral biologic medicines, announced that the University of Chicago has dosed the first patient in an investigator-sponsored Phase 2a clinical trial evaluating EDP1503 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy. EDP1503 is an orally delivered monoclonal microbial product candidate being developed for the treatment of cancer.
This open-label clinical trial, led by Dr. Jason J. Luke, M.D., FACP, will evaluate 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. Evelo will provide and retain all rights to EDP1503.
Patients will receive daily EDP1503 monotherapy for two weeks followed by treatment with daily EDP1503 in combination with KEYTRUDA®. The study will evaluate biomarkers identified from paired biopsies taken before and after the two-week run-in, as well as clinical outcomes observed over the course of the trial, and potential alterations to the intestinal microbiome. Evelo anticipates initial clinical data from the trial in the second half of 2020.
In preclinical studies orally delivered EDP1503 shows activation of multiple clinically validated systemic immune pathways which are complementary to and potentially synergistic with checkpoint inhibitors. Effects include increased CXCL9 and CXCL10 production in the tumor microenvironment, augmentation of NK and T cell infiltration to the tumor site as well as upregulation of MHC Class I expression in tumors.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.