Enliven Therapeutics Unveils Favorable Early Data from Phase 1 ELVN-001 Trial for CML Patients

Enliven Therapeutics, a biopharmaceutical firm, has reported encouraging early results from a Phase 1 clinical trial of ELVN-001, a novel small molecule kinase inhibitor targeting chronic myeloid leukemia (CML). The drug demonstrated a 44% major molecular response (MMR) rate in patients by 12 weeks, which is on par with previous trials of approved BCR::ABL1 tyrosine kinase inhibitors (TKIs). Notably, this includes patients previously treated with asciminib, a TKI, indicating ELVN-001's potential in treating drug-resistant cases. The drug has shown a good safety profile with no severe non-hematologic side effects reported. 

The study, involving 27 heavily pre-treated patients, revealed that ELVN-001 was active across a broad dosage range, with 89% of participants maintaining stable or improved BCR::ABL1 transcript levels. The drug's pharmacokinetic profile suggests suitability for once-daily dosing without significant food interaction or drug-drug interaction risks. At higher doses, ELVN-001 achieved superior target coverage compared to second-generation TKIs, positioning it as a potential best-in-class treatment. 

Enliven's CEO, Sam Kintz, expressed optimism about the drug's initial data, highlighting its potential to address the limitations of current TKIs and its tolerability. The company hosted a virtual event with key opinion leaders to discuss the drug's implications for CML treatment. The Phase 1 trial's primary endpoint is safety, with secondary endpoints including pharmacokinetics, MMR, duration of MMR, BCR::ABL1 transcript levels, and complete hematologic response. 

ELVN-001 is designed to target the BCR-ABL gene fusion, a key driver in CML, and is also effective against the T315I mutation, which is resistant to most TKIs. Enliven Therapeutics, based in Boulder, Colorado, is dedicated to developing precision oncology treatments that improve survival and quality of life for cancer patients. The company's approach combines insights into clinically validated targets with innovative chemistry to create potentially first-in-class or best-in-class therapies. 

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