On November 27, 2018 Evelo Biosciences, Inc. (NASDAQ:EVLO) ("Evelo"), a clinical-stage biotechnology company developing monoclonal microbials to engage immune cells in the small intestine and drive changes in systemic biology, reported that it has entered into a clinical trial collaboration agreement with Merck (known as MSD outside the US and Canada) (Press release, Evelo Biosciences, NOV 27, 2018, View Source [SID1234531985]). 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.
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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: microsatellite 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 (CT.gov: NCT03595683). First patient dosing in this study is expected by the end of 2018.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
About EDP1503
EDP1503 is Evelo’s first monoclonal microbial oncology product candidate and is being developed under the umbrella of its exclusive worldwide license with the University of Chicago. Under this license, Evelo has exclusive patent rights related to the administration of microbes to treat cancer, including in combination with checkpoint inhibitors. The patent rights describe many genera of microbes and will provide broad patent protection. A US patent covering the combination of Bifidobacteria and checkpoint inhibitors to treat cancer was granted in January 2018. Preclinical data suggests that EDP1503 is active through different and complementary immune mechanisms beyond those targeted by checkpoint inhibitors. In preclinical models, EDP1503 alone stimulated upregulation of the immune response to tumors, delayed tumor progression and, when combined with a checkpoint inhibitor, showed additive effects in delaying tumor progression.