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BlossomHill Therapeutics Announces Collaboration with Foundation Medicine to Develop First Companion Diagnostic for BH-30643 in EGFR C797S Mutated Non-Small Cell Lung Cancer

BLSM
  • BlossomHill Therapeutics, Inc. (NASDAQ: BLSM) announced a collaboration with Foundation Medicine, Inc. to develop a companion diagnostic assay (CDx) for the EGFR C797S resistance mutation.
  • The partnership will utilize the ongoing Phase 1/2 SOLARA clinical trial evaluating BH-30643 in EGFR-mutant non-small cell lung cancer (NSCLC) patients to validate the assay.
  • EGFR C797S is identified as the primary mutation driving resistance to osimertinib treatment in EGFR-mutant NSCLC.
  • BH-30643 is an investigational, macrocyclic mutant-selective OMNI-EGFR™ inhibitor designed to target the C797S mutation that causes resistance to standard therapies.
  • Geoff Oxnard, MD, Chief Medical Officer at BlossomHill, stated that addressing unmet needs for patients with known resistance mutations following progression on prior EGFR therapy is the near-term development priority.
  • BH-30643 received Fast Track designation for the C797S resistance population after third-generation EGFR TKI treatment.
  • The global SOLARA trial (NCT06706076) is a Phase 1/2 study spanning over 40 sites in 10 countries to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity.
  • Preclinical data indicated BH-30643 demonstrates potent inhibitory activity across classical mutations, on-target resistance mutations (including C797S with or without T790M), atypical mutations, and exon 20 insertions while maintaining selectivity over wild-type EGFR.
  • BlossomHill Therapeutics is headquartered in San Diego, California, and is led by founder J. Jean Cui, Ph.D., who has a track record of developing three FDA-approved drugs.
  • The company's pipeline also includes BH-30236, a macrocyclic CDC-like kinase inhibitor for relapsed or refractory acute myeloid leukemia, and BH-501284, a preclinical pan-KRAS Switch-II inhibitor.