On February 4th, 2019 ENB Therapeutics, Inc., a clinical-stage, biopharmaceutical company developing innovative, endothelin-based oncologics, reported that it has entered into a clinical collaboration agreement with Merck (known as MSD outside the U.S. and Canada) to evaluate the combination of ENB-003, a first-in class endothelin B receptor ("ETBR") inhibitor and Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in a Phase 1/2 trial in patients with advanced solid tumors (Press release, ENB Therapeutics, FEB 4, 2019, View Source [SID1234626430]). The open-label, dose-escalation and expansion Phase 1/2 study will enroll patients with anti-PD-1 resistant malignant melanoma, platinum-resistant ovarian or pancreatic cancer with previous treatment failure. The dose escalation phase of the trial will evaluate the safety and tolerability of various doses of ENB-003 as a monotherapy and in combination with KEYTRUDA. The dose expansion will evaluate preliminary efficacy, safety and tolerability of the selected dose of ENB-003 combined with KEYTRUDA as well as changes in immunohistochemistry and pharmacodynamic biomarkers after administration of ENB-003.
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"We are thrilled to collaborate with Merck, an established leader in the field of cancer immunotherapy," said Sumayah Jamal, M.D., Ph.D., President and CSO of ENB Therapeutics. "ENB-003 has both antitumor and immune-modulatory effects and augments the efficacy of anti-PD-1 inhibition in animal models. We are optimistic about exploring the combination of ENB-003 and KEYTRUDA ."
Under the terms of the agreement, ENB Therapeutics will sponsor the ENB-003 and KEYTRUDA clinical study.
Keytruda is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.