Ensem Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial of ETX-636, a Potential Best-In-Class Allosteric Pan-Mutant-Selective PI3Kα Inhibitor and Degrader
Ensem Therapeutics, Inc. (ENSEM), a clinical stage, oncology-focused biopharmaceutical company, today announced the first patient has been dosed in its phase 1/2 study of ETX-636, a potential best-in-class novel allosteric pan-mutant-selective PI3Kα inhibitor and degrader.
Ensem Therapeutics Announces U.S. FDA IND Clearance to Initiate Clinical Development of ETX-636
Ensem Therapeutics, Inc. (ENSEM) today announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for ETX-636, a potential best-in-class novel allosteric pan-mutant-selective PI3Kα inhibitor and degrader, with its first-in-human study anticipated in the second quarter of 2025. In addition, ENSEM will present preclinical data on April 28th at the American Association for Cancer Research (“AACR”) Annual Meeting in Chicago, Illinois, supporting a differentiated profile of ETX-636 and its potential to deliver clinical benefit to patients with tumors harboring activating PI3Kα mutations.
Ensem Therapeutics Announces Presentation at 43rd Annual J.P. Morgan Healthcare Conference
Ensem Therapeutics, Inc. (ENSEM), a pioneering drug discovery and development company that leverages its unique Kinetic Ensemble® platform to advance innovative small molecule precision medicines for oncology, today announced that Dr. Shengfang Jin, Chief Executive Officer of ENSEM, will present an overview of the company and its pipeline progress at the 43rd Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2025 at 7:30 a.m. PT/ 10:30 a.m. ET.
Ensem Therapeutics To Present Preclinical Data for Potential Best-in-Class Oral CDK2 Inhibitor at San Antonio Breast Cancer Symposium
Ensem Therapeutics, Inc. (ENSEM), a pioneering drug discovery and development company that leverages its unique Kinetic Ensemble® platform to advance innovative small molecule precision medicines for oncology, will report for the first time preclinical data on ETX-197/BG-68501, a potential best-in-class oral, selective CDK2 inhibitor at the 47th Annual San Antonio Breast Cancer Symposium (“SABCS”) in San Antonio, Texas. ETX-197/BG-68501 has a differentiated preclinical profile and the potential to deliver clinical benefit to patients with tumors associated with CDK2 dependency.
Ensem Therapeutics To Present Preclinical Data for Potential Best-in-Class Allosteric Pan-Mutant-Selective PI3Kα Inhibitor and Degrader at San Antonio Breast Cancer Symposium
Ensem Therapeutics, Inc. (ENSEM), a pioneering drug discovery and development company that leverages its unique Kinetic Ensemble® platform to advance innovative small molecule precision medicines for oncology, today announced the first presentation of preclinical data on ETX-636, a potential best-in-class novel allosteric pan-mutant-selective PI3Kα inhibitor and degrader. ETX-636 has a differentiated preclinical profile and the potential to deliver clinical benefit to patients with tumors harboring all forms of mutant PI3Kα. The ETX-636 preclinical data is being presented in a poster session during the 47th Annual San Antonio Breast Cancer Symposium (“SABCS”) in San Antonio, Texas, on Dec. 12.
Ensem Therapeutics Announces Achievement of Milestone Following Entry of Small Molecule CDK2 Inhibitor into Clinical Trials for Solid Tumors
Ensem Therapeutics, Inc. today announced that its partner BeiGene has dosed the first five patients in its first-in-human Phase 1 trial to evaluate BG-68501, a small molecule cyclin-dependent kinase 2 (CDK2) inhibitor for the treatment of solid tumors. The achievement triggers a milestone payment from BeiGene, which licensed the compound (formerly ETX-197) from ENSEM in November 2023. BG-68501 is the first clinical stage compound to emerge from ENSEM’s Kinetic Ensemble® platform, a suite of novel AI/ML, computational and experimental technologies to uncover cryptic pockets in target proteins for drug discovery.
