ENB Therapeutics, a biotechnology firm working on therapeutics targeting the endothelin B receptor (ETBR), announced the completion of its international Phase 1 ENBOLDEN-101 trial enrollment.

The trial aims to investigate the safety and efficacy of ENB-003, the company’s lead product, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab).

This Phase 1/2a study is an open-label, multicenter trial conducted across the United States and Australia, divided into two parts. Part 1 recruited 46 patients for a dose-escalation study, designed to determine the optimal dose for Part 2, which is the study’s expansion phase. The findings from this study will be presented at the upcoming Immuno-oncology Summit in Boston, Massachusetts, from August 7-9, 2023, in a poster by ENB Therapeutics.

The combination of ENB-003 and pembrolizumab was well tolerated in the dose escalation study, showing no dose-limiting toxicities (DLTs) across six dosing cohorts. The most common treatment-related adverse events were fatigue, constipation, abdominal pain, nausea, anemia, and diarrhea.

“The completion of enrollment of the Phase 1 ENBOLDEN-101 first-in-man study is a significant milestone for our Company. We are extremely encouraged by the results in heavily treated cancer patients refractory to standard of care treatment,” said Sumayah Jamal, President, Chief Scientific Officer and Co-Founder of ENB Therapeutics.

Part 2, the dose expansion study, will evaluate the safety, tolerability, and efficacy of ENB-003 in combination with pembrolizumab in cancers refractory to standard care, including MSS R/R ovarian cancer, MSS pancreatic cancer, anti-PD1 refractory HNSCC, anti-PD1 refractory melanoma and anti-PD1 refractory TNBC. ENB-003 has shown promise in preclinical studies to enhance the efficacy of CAR-T and anti-PD-1 in solid tumors across multiple cancer types.

  Australia, cancer, ENB-003, Keytruda, Merck, Oncology, pembrolizumab, Sumayah Jamal, USA