BlossomHill Therapeutics Announces Collaboration with Foundation Medicine to Develop First Companion Diagnostic for BH-30643 in EGFR C797S Mutated Non-Small Cell Lung Cancer
Key Highlights
- ➤Foundation Medicine collaboration targets first CDx for EGFR C797S mutation
- ➤BH-30643 Phase 1/2 SOLARA trial spans 40-plus sites in 10 countries
- ➤C797S cohort enrolling alongside TKI-pretreated and TKI-naive cohorts
- ➤BH-30643 received Fast Track designation for C797S resistance population
Expert Statements
Geoff Oxnard, Chief Medical Officer at BlossomHill Therapeutics
“Our near-term development priority for BH-30643 is to address the unmet needs of EGFR-mutant NSCLC patients with known resistance mutations following progression on prior EGFR targeted therapy.”
Geoff Oxnard, Chief Medical Officer at BlossomHill Therapeutics
“Foundation Medicine is the most experienced developer of precision CDx assays and the ideal partner to help us characterize EGFR resistance and validate a CDx assay to support the development of our medicine.”
SAN DIEGO, Oct. 22, 2026 (GLOBE NEWSWIRE) -- BlossomHill Therapeutics, Inc. (Nasdaq: BLSM), a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines for the treatment of cancer, today announced a collaboration with Foundation Medicine, Inc. to develop a companion diagnostic assay (CDx) for the EGFR C797S resistance mutation. The collaboration will leverage the ongoing Phase 1/2 SOLARA clinical trial evaluating BH-30643 in the targeted treatment of epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) patients to validate the assay.
EGFR C797S is the most common EGFR mutation driving resistance to osimertinib treatment in EGFR-mutant NSCLC. BH-30643 is a macrocyclic mutant-selective OMNI-EGFR™ inhibitor that has demonstrated clinical activity against a variety of EGFR mutations, in particular the C797S mutation that drives resistance to standard therapy. Understanding and targeting resistance mechanisms to existing EGFR inhibitors is an active area of clinical investigation and drug development. To this end, the collaboration will focus on validating a reliable diagnostic assay for the detection of EGFR C797S mutation to help guide BH-30643’s ongoing development.
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