Last week, President and Co-Founder Sumayah Jamhal presented her company, ENB Therapeutics, at the 2023 Immuno-Oncology 360 Degree Conference in New York City.
ENB Therapeutics is a clinical stage, privately held company creating therapies to treat drug resistant cancer by reprogramming the tumor microenvironment. Their lead product, ENB-003 is a first-in-class small molecule, selective endothelin receptor type B (ETBR) inhibitor. ENB-003 is currently in its’ phase 1 clinical trial with Merck.
The ETBR is present on the luminal surface of tumor blood vessels which downregulate ICAM-1, an adhesion molecule. ENB-003, a ETBR blocker, restores ICAM-1 expression, which allows T-cells to leave the circulation, infiltrate, and kill the tumor. ETBR has been linked to melanoma and other cancers in over 200 peer-reviewed publications. However, there is no drug on the market or ever tested in clinical trials that specifically blocks the ETBR.
Orphan Drug Designation for Melanoma & Pancreatic Cancer
In May 2022, the U.S. FDA granted Orphan Drug Designation for ENB-003 for the treatment of pancreatic cancer. ENB-003 has also been granted Orphan Drug Designation for melanoma in 2016. Orphan Drug Designation is granted for novel rare disease therapies and provides ENB Therapeutics with assistance during the development process and other incentives.
The ongoing phase 1 trial is evaluating the safety and tolerability of ENB-003 with pembrolizumab to determine a recommended Phase II dose expansion trial. The expected primary objective for the Phase II trial is to evaluate the ability to enhance responsiveness to pembrolizumab in patients who previously failed pembrolizumab therapy or have tumors resistant to pembrolizumab therapy. “Our Phase 1/2 trial will exclude patients with pancreatic tumors that have the molecular alterations known as high microsatellite instability (MSI-H) or defective DNA mismatch repair (dMMR). Thus, we are targeting truly pembrolizumab resistant patients to evaluate the potential for a ENB-003 + pembrolizumab combination as a potential treatment for this population with clear and significant unmet need,” said Dr. Jamal, Co-Founder and Chief Scientific Officer of ENB Therapeutics.
Other agents in the pipeline include ENB004, ENB005, and ENB006 which are second-generation oral selective ETBR inhibitors currently in the preclinical and discovery stages.