ENB Therapeutics Demonstrated Early Efficacy in Phase I Clinical Trial of ENB-003 in Combination with Pembrolizumab

Monday, February 1, 2021 8:00 AM https://www.accesswire.com/viewarticle.aspx?id=626781 ENB-003 is the Company’s first in class small molecule therapeutic selectively targeting the ETB receptor – a novel immune checkpoint  NEW YORK, NY / ACCESSWIRE / February 1, 2021 / ENB Therapeutics, Inc., a biotechnology company pioneering a new and differentiated class of therapeutics targeting the ETB receptor (ETBR), today announced the successful completion of the third dosing cohort in a Phase I dose escalation clinical trial of ENB-003 in combination with pembrolizumab. 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 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. “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...

Early efficacy signals in ovarian cancer patients in ongoing Ph1 trial: Poster reporting findings presented at SITC 2020 Annual Meeting

ENB Therapeutics reports preliminary data from the ongoing Phase 1/2 trial assessing the safety and efficacy of lead product ENB-003 in combination with pembrolizumab. Safety data are encouraging with no significant drug related safety events from the first 3 dosing cohorts. Best overall responses from the first 6 patients include 2 disease stabilizations and 1 confirmed partial response. The most encouraging responses were observed in 2 patients with platinum-resistant ovarian cancer who demonstrated 6% and 60% reduction in target lesions at the 150ug and 300ug doses respectively. The 150ug dose was sub therapeutic based upon weight and we anticipate enhanced efficacy as we continue to dose escalate. Download the poster by clicking the link below....

ENB Therapeutics Announces Successful Completion of the First Dosing Cohort in Phase 1 Clinical Trial of ENB-003 in Combination with Pembrolizumab

Monday, June 15, 2020 3:45 PMENB-003 is the Company’s first in class small molecule therapeutic selectively targeting the ETB receptor – a novel immune checkpoint NEW YORK, NY / ACCESSWIRE / June 15, 2020 / ENB Therapeutics, INC., a biotechnology company pioneering a new and differentiated class of therapeutics targeting the ETB receptor (ETBR), today announced the successful completion of the first dosing cohort in a Phase I dose escalation of ENB-003 in combination with pembrolizumab. 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.“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....

IND approval received for lead product ENB-003

January 17, 2020 ENB Therapeutics receives IND approval from the FDA for our Phase 1/2 trial evaluating the safety and efficacy of lead product ENB-003 in combination with pembrolizumab. This is a major milestone for ENB and allows our clinical trial to be initiated as planned later this...

ENB Therapeutics Announces Clinical Trial Collaboration with Merck to Evaluate ENB-003 in combination with KEYTRUDA® (pembrolizumab) for Advanced Solid Tumors

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...