Enliven announces pipeline updates

Recent Research and Development Updates and Upcoming Milestones: ELVN-001, a highly selective, small molecule kinase inhibitor designed to specifically target the BCR-ABL gene fusion: The Company is currently enrolling patients in its Phase 1 clinical trial evaluating ELVN-001 in adults who failed or are intolerant to available therapies known to be active for the treatment of their CML, and will host a key opinion leader event with CML Investigators Professor Michael Mauro of Memorial Sloan-Kettering Cancer Center and Professor Fabian Lang of Goethe University Hospital, on April 11, 2024, to discuss initial proof of concept data from the trial. More details of the event will be announced soon. In the ongoing Phase 1a dose escalation, 10-120mg once daily, ELVN-001 has been well tolerated with anti-CML activity at and above 20mg QD, including both achievement and maintenance of major molecular responses by three months in late line patients, and in patients with prior asciminib experience. A maximum tolerated dose has not been reached, and there have been no dose reductions. Of note, there have been no greater than or equal to Grade 3 non-hematologic treatment-related adverse events and of the Grade 1/2 non-hematologic TRAE, none greater than 11%. At above 20mg QD, ELVN-001 achieved superior target coverage compared to 2nd Generation TKIs. More detailed ELVN-001 data will be presented at the April 11th KOL event. ELVN-002, a potent, highly selective, central nervous system penetrant and irreversible HER2 inhibitor with activity against wild type HER2 and various HER2 mutations: Following the U.S. Food and Drug Administration’s approval of its Investigational New Drug application, the Company recently activated its first site to evaluate ELVN-002 in combination with trastuzumab +/- chemotherapeutic agents in adults with HER2+ metastatic breast cancer and colorectal cancer. Dosing of the first patient in the combination study is expected in Q2 2024. The combination trial in patients with HER2+ cancers is supported by the initial data from the ongoing monotherapy trial, which includes: Investigator reported responses in both HER2+ and HER2 mutant tumors, including in patients who have progressed on Enhertu and patients with brain metastases, at doses that have been well tolerated. At the clinically predicted optimal monotherapy dose, based on current Phase 1a data: The most common reported treatment-related adverse events were headache, nausea, vomiting and diarrhea. Of note, no Grade 3 diarrhea and only Grade 1/2 AST/ALT and rash. Compared to tucatinib, ELVN-002 had greater than10x target coverage based on pharmacokinetics in cancer patients and preclinical HER2+ efficacy. Phase 1 data and initial proof of concept combination data in HER2+ cancers are expected in 2025.