Evelo Biosciences Announces Dosing of First Patient in Phase 1/2 Clinical Trial of EDP1503 in Combination with KEYTRUDA® (pembrolizumab) in Multiple Oncology Indications

-- Initial Clinical Data Expected in First Half of 2020 –

CAMBRIDGE, MA, USA I January 04, 2019 I Evelo Biosciences, Inc. (NASDAQ:EVLO) (“Evelo”) a biotechnology company developing monoclonal microbials, a new modality of oral biologic medicines, today announced that it has dosed the first patient in its Phase 1/2 clinical trial of 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 will evaluate the safety, tolerability, immune response markers, and overall response rates achieved with EDP1503 in combination with KEYTRUDA® in up to 120 patients across three groups: microsatellite stable colorectal cancer; triple-negative breast cancer; and patients across multiple tumor types who have relapsed on prior PD-1/L1 inhibitor treatment.

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. Evelo expects to report initial clinical data from the trial in the first half of 2020.

“This clinical trial of EDP1503 will allow us to explore the potential synergies between EDP1503 and KEYTRUDA® and offers the potential to treat multiple cancer types that are otherwise poorly responsive to checkpoint inhibitors,” said Humphrey Gardner, M.D., FCAP, chief of medical oncology at Evelo.

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.

About Evelo Biosciences

Evelo Biosciences, Inc. is a clinical-stage biotechnology company developing monoclonal microbials, a new modality of oral biologic medicines. Evelo’s product candidates are orally-delivered, single strains of microbes, selected for defined pharmacological properties. They are developed to engage immune cells in the small intestine and drive changes in systemic biology. Evelo believes that monoclonal microbials have the potential to be broadly applicable across many diseases including immunoinflammatory, cancer, autoimmune, metabolic, and neuroinflammatory diseases.

Evelo currently has three product candidates in clinical development, EDP1066 and EDP1815 for the treatment of inflammatory diseases and EDP1503 for the treatment of cancer, for which ten clinical readouts are expected during 2019 and 2020. Evelo is also advancing additional candidates through preclinical development in other disease areas.

For more information, please visit www.evelobio.com.

SOURCE: Evelo Biosciences

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