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ENB is developing first in class small molecule ENB-003 to selectively targeting the ETB receptor – a novel immune checkpoint
- The ENB-003 in combination with KEYTRUDA® (pembrolizumab) was well tolerated
- Promising preliminary efficacy signals with 33% disease control rate (DCR) across all cohorts
- Efficacy appears to correlate with endothelin B receptor (ETBR) expression: 83% DCR in ETBR-Hi patients in cohort 6 (RP2D)
- Platinum refractory/ resistant microsatellite stable ovarian cancer patients with 80% DCR across all cohorts
ENB Therapeutics, Inc., a biotechnology company pioneering a new and differentiated class of therapeutics targeting the endothelin B receptor (ETBR) inhibitor, today announced that the company has completed enrollment of its international Phase 1 ENBOLDEN-101 trial investigating the safety and efficacy of lead product ENB-003 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy. The Phase ½a study is a multicenter, open-label study conducted in the US and Australia and is comprised of two parts. Part 1 recruited 46 patients and was a dose-escalation study to determine the recommended dose for the Part 2 expansion phase of the study. The results of this study will be presented by ENB Therapeutics in a poster titled, “ENB-003, an ETBR antagonist, in combination with pembrolizumab for refractory advanced solid tumors: Topline data from the ENBolden-101 Phase 1B study” at the Immuno-oncology Summit which is being held August 7-9, 2023 in Boston, Massachusetts.
ENB-003 in combination with pembrolizumab was well tolerated in the dose escalation study and demonstrated no DLTs across the 6 dosing cohorts. The most common treatment emergent adverse events irrespective of grade or causality included fatigue (28.2%), constipation (26.1%), abdominal pain (26.1%), nausea (23.9%), anemia 17.4%, diarrhea (17.4%). Serious adverse events, grade 3 and above considered possibly related to study treatment included…
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