Enliven Therapeutics has decided against taking its phase 1-stage solid tumor drug into further development next year in order to keep resources flowing toward its leukemia candidate.
The Colorado-based biotech is currently evaluating ELVN-002, which is designed to inhibit the HER2 pathway in solid tumors, in a pair of phase 1 trials. One of these studies is looking at ELVN-002 in combination with AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu as a treatment for HER2-positive breast cancer. The other study is looking at ELVN-002 in combination with Roche’s Herceptin for patients with HER2-positive colorectal cancer.
However, Enliven said in its first-quarter earnings release that it now “plans to explore strategic alternatives for the ELVN-002 program and does not intend to pursue its development beyond 2025.”
Mothballing work on ELVN-002 means Enliven can prioritize the upcoming pivotal trial of ELVN-001. The small-molecule kinase inhibitor is designed to inhibit BCR-ABL gene fusion, which is the oncogenic driver of chronic myeloid leukemia (CML).
In an ongoing phase 1 trial, 44% of 36 evaluable patients with previously treated CML have experienced a major molecular response—meaning the level of the BCR-ABL1 gene is reduced to 0.1% or less—by 24 weeks, the biotech reported in the same May 14 release.
Multiple BCR-ABL tyrosine kinase inhibitors are marketed to treat CML including Novartis’ Gleevec, Tasigna and Scemblix, Bristol Myers Squibb’s Sprycel and Pfizer’s Bosulif. But Enliven said its latest data “compare favorably to precedent phase 1 trials of the approved BCR::ABL1 tyrosine kinase inhibitors, particularly given the more heavily pre-treated patient population in the ELVN-001 clinical trial.”
“We continue to gain confidence and momentum in the program as the efficacy, safety and tolerability data consistently compare favorably to the approved BCR::ABL inhibitors,” Enliven’s CEO Sam Kintz added in yesterday’s release.
“Looking towards the rest of the year, we remain focused on clinical execution as we prepare for the potential start of a pivotal trial for ELVN-001 in 2026,” Kintz added.
Having called time on further development of ELVN-002, Enliven now expects the $289.6 million it ended March with to last into late 2027.