On February 1, 2021 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 third dosing cohort in a Phase I dose escalation clinical trial of ENB-003 in combination with pembrolizumab (Press release, ENB Therapeutics, FEB 1, 2021, View Source [SID1234634064]). Doses of ENB-003 administered to date appear well-tolerated and as the trial progressed into the anticipated therapeutic range of ENB-003 has demonstrated its first efficacy signal as was reported at the SITC (Free SITC Whitepaper) 2020 annual meeting. 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 very excited to observe the continued safety of our combination regimen as well as early efficacy signals as we escalate the dose into the expected therapeutic window of ENB-003. Best overall responses of the 9 patients dosed to date include 4 SD (stable disease) and one PR (partial response) in a platinum refractory ovarian cancer subject who had a ~72% reduction in tumor burden with deepening of response and no disease progression at 6 months of therapy. Median PFS with pembrolizumab alone in recurrent ovarian cancer is 2.3 months," said Sumayah Jamal, MD-PhD, President, Co-Founder and CSO of ENB Therapeutics, Inc. "We are hoping for continued positive responses as we advance the trial and escalate the dose of ENB-003."
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 trial includes a monotherapy run-in followed by combination therapy. 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 trial with the primary objective to evaluate ENB-003’s ability to enhance responsiveness to pembrolizumab in patients who have previously failed pembrolizumab therapy or have tumors associated with pembrolizumab resistance.