Thursday, Enliven Therapeutics Inc (NASDAQ:ELVN) released proof of concept data from the Phase 1 clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia (CML) who are relapsed, refractory, or intolerant to available tyrosine kinase inhibitors (TKIs).

ELVN-001 is a small molecule kinase inhibitor designed to specifically target the BCR-ABL gene fusion, the oncogenic driver for patients with CML.

“We are excited to present the first look at the safety and clinical activity of ELVN-001, which we believe supports the potential for ELVN-001 to address the limitations of the available active-site TKIs,” said Helen Collins, Chief Medical Officer of Enliven. 

Related Content: Enliven Therapeutics Well-Positioned, With Conservative Trading Levels-Analyst Says.

As of the cutoff date, March 18, 2024, 27 patients had enrolled in the ongoing Phase 1 clinical trial across five dose levels of ELVN-001, ranging from 10mg once daily (QD) to 120mg QD. 

ELVN-001 achieved a cumulative major molecular response (MMR) rate of 44% (7/16) by 12 weeks and demonstrated responses in patients with prior exposure to asciminib and who were TKI-resistant:

Among response-evaluable patients, all had improved or stable BCR::ABL1 transcript levels by 12 weeks.

ELVN-001 has been well tolerated, consistent with its selective kinase profile, with no ≥ Grade 3 treatment-related non-hematologic toxicities reported.

A maximum tolerated dose has not been identified, and there have been no dose reductions.

ELVN-001’s PK profile supports once-daily dosing with flexible administration requirements (no significant food effect and minimal risk of drug-drug interactions).

Price Action: ELVN shares are up 23.60% at $24.50 on the last check Thursday.