New York, NY., February 4th, 2019 — ENB Therapeutics, Inc., a clinical-stage, biopharmaceutical company developing innovative, endothelin-based oncologics, today announced 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.
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.
“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.
About ENB Therapeutics
ENB Therapeutics is a biopharmaceutical company pioneering the development of selective inhibitors of the endothelin B receptor (“ETBR”) to reverse the drug resistance that occurs in over 50% of patients treated with immunotherapy. Our lead product, ENB-003, a first-in-class, selective, small molecule inhibitor of ETBR, has been demonstrated to significantly reduce tumor growth and prolong survival in a variety of immunotherapy-resistant cancers in multiple, preclinical in-vivo studies. ENB-003 is being developed as a companion agent to unlock the full therapeutic potential of immunotherapy by restoring the ability of T-cells to infiltrate tumors, inhibit metastasis and increase survival. Over-expression of the ETBR in the tumor microenvironment of more than 40% of all cancers provides additional opportunities to expand into multiple indications across the rapidly growing immunotherapy market. In 2017, cancer immunotherapy sales are estimated to have exceeded $57 billion in annual sales.