Business
Enliven Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Business Update
Initial proof of concept data from Phase 1a trial evaluating ELVN-001 in adults with chronic myeloid leukemia (CML) is expected in the second quarter of 2024
About this update from Enliven Therapeutics, Inc.
[{"type":"text","content":"Initial proof of concept data from Phase 1a trial evaluating ELVN-001 in adults with chronic myeloid leukemia (CML) is expected in the second quarter of 2024 IND application to evaluate ELVN-002 in combination with trastuzumab in patients with HER2+ metastatic breast cancer and colorectal cancer received U.S. FDA clearance Strong balance sheet, closing the year with $253 million in cash, cash equivalents and marketable securities BOULDER, Colo., March 14, 2024 (GLOBE NEWSWIRE) -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage precision oncology company focused on the discovery and development of next-generation small molecule kinase inhibitors, today reported financial results for the fourth quarter and full year ended December 31, 2023, provided updated guidance on parallel lead product candidates and highlighted pipeline progress. “We are pleased with the ongoing momentum of our clinical pipeline. Our Phase 1 trial of ELVN-001 is on track, and we are excited to share our initial proof of concept data in the second quarter of 2024,” said Sam Kintz, MBA, Enliven’s Co-founder and Chief Executive Officer. “Furthermore, the FDA’s acceptance of our second ELVN-002 IND application paves the way to evaluate combination therapy in patients with HER2+ cancers, for which there remains a significant unmet need, particularly in patients who progress on or are intolerant to Enhertu. We are focused on getting the trial up and running and dosing the first patient by mid-2024.” Recent Research and Development Highlights and Upcoming Milestones ELVN-001, a highly selective, small molecule kinase inhibitor designed to specifically target the BCR-ABL gene fusion Patient enrollment in the Phase 1 clinical trial in adults with CML (NCT05304377) remains ongoing, and the Company has nearly completed the Phase 1a dose escalation portion of the trial.The first clinical data disclosure is expected in the second quarter of 2024. The Company expects this data to include more than 20 patients enrolled at an efficacious dose range, with 10 to 20 of those patients having been treated for over three months at the time of disclosure. ELVN-002, a potent, highly selective, central nervous system (CNS) penetrant and irreversible HER2 inhibitor with activity against wild type HER2 and various HER2 mutations The Company’s Inves...