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BlossomHill Therapeutics Begins Trial of BH-30643 in EGFR-, HER2-Mutant NSCLC

NEW YORK – BlossomHill Therapeutics on Wednesday said it has begun treating lung cancer patients with EGFR- or HER2-mutated tumors with its OMNI-EGFR inhibitor BH-30643 in a Phase I/II trial.

The trial, called SOLARA, will involve patients with locally advanced or metastatic non-small cell lung cancer harboring a range of EGFR mutations, including classical, atypical, and exon 20 insertion mutations, and HER2 mutations in the kinase domains of exons 18, 19, 20, or 21. Patients with compound mutations or acquired resistance mutations in EGFR will also be included in the study.

BH-30643 is designed to have high potency against common, atypical, and compound EGFR mutations while having low potency against wild-type EGFR to decrease toxicity. About two-thirds of observed EGFR mutations fall into the category of classical mutations, the most common type targeted by earlier generation EGFR inhibitors, while one-third are atypical mutations, according to BlossomHill. The treatment also targets HER2-activating mutations, a common mechanism of resistance to EGFR inhibitors that occurs in about 4 percent of NSCLC patients.

"EGFR-mutant lung cancer is one of the most common genomic subtypes of lung cancer globally and has been a major target of drug development in recent years, yet an unmet medical need remains for patients," BlossomHill Chief Medical Officer Geoff Oxnard said in a statement. "Our thesis is that the novel, macrocyclic design of BH-30643 will provide potent antitumor activity in a broader spectrum of EGFR-mutant lung cancers with reduced toxicity."

San Diego-based BlossomHill is also developing BH-30236, a CLK inhibitor, for treating acute myeloid leukemia and higher-risk myelodysplastic syndrome.