On June 15, 2020 ENB Therapeutics, INC., a biotechnology company pioneering a new and differentiated class of therapeutics targeting the ETB receptor (ETBR), reported the successful completion of the first dosing cohort in a Phase I dose escalation of ENB-003 in combination with pembrolizumab (Press release, ENB Therapeutics, JUN 15, 2020, View Source [SID1234634060]). The Phase I trial includes a monotherapy run-in followed by combination therapy. Doses of ENB-003 administered to date appear well-tolerated and the safety review committee has approved the dose escalation. ENB-003 is a selective and potent inhibitor of the ETBR receptor which is overexpressed in over 40% of all tumor types and blocks T-cell trafficking, thus creating "cold" tumors which have a high unmet need.
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"We are pleased that the doses of ENB-003 administered to date in combination with pembrolizumab appear to be very well tolerated and that our safety committee has approved moving on to the next higher dose," said Sumayah Jamal, MD-PhD, President, Co-Founder and CSO of ENB Therapeutics, Inc. "We are very excited to have cleared this initial safety hurdle in the first clinical trial of a selective ETBR inhibitor (ETBRI) for cancer immunotherapy. ETBRIs have demonstrated preclinical proof of concept for overcoming anti-PD1 resistance across multiple cancer types. We believe that ENB-003, when combined with pembrolizumab in the anti-PD1 resistant patient population, may result in enhanced anti-tumor activity and immunologic effects."
The Phase I/II multi-center, open-label trial of ENB-003 is currently enrolling patients with advanced solid tumors in indications associated with ETBR expression. The Phase I dose escalation of ENB-003 in combination with pembrolizumab is primarily designed to assess safety and tolerability and to determine a recommended Phase II dose (RP2D). Following selection of an RP2D, we expect to initiate a Phase II dose expansion portion with the primary objective of evaluating the clinical ability of ENB-003 to enhance responsiveness to pembrolizumab in patients who have previously failed pembrolizumab therapy or have tumors associated with pembrolizumab resistance.