BlossomHill Therapeutics, Inc., a privately-held, clinical-stage biotechnology company focused on the design and development of small molecule medicines for treating cancer and autoimmune diseases, today announced the first patient dosed in the expansion cohorts of the SOLARA trial (NCT06706076), the first-in-human trial of BH-30643, a first-in-class, macrocyclic, non-covalent, mutant selective OMNI-EGFR^TM inhibitor having sub-nanomolar potency against classical and atypical EGFR mutations that is maintained even in the presence of T790M +/- C797S resistance mutations.

SOLARA is a global, open label, Phase 1/2 clinical trial assessing the safety, efficacy and tolerability of BH-30643 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) bearing EGFR or HER2 mutations. The expansion cohorts of the SOLARA trial will assess single-agent objective response rate (ORR) of BH-30643 in NSCLC patients with diverse EGFR mutations, including patients who have not received prior EGFR targeted therapy. Dosing of patients in the expansion cohorts follows the SOLARA trial’s dose escalation experience which successfully demonstrated favorable pharmacokinetic (PK) and tolerability profiles of BH-30643 as well as preliminary anti-tumor activity in previously treated EGFR-mutant NSCLC.

“Our goal at BlossomHill is to make the next leap forward in the treatment of EGFR-mutant lung cancer,” said Dr. Geoff Oxnard, Chief Medical Officer of BlossomHill Therapeutics. “Enrollment of the SOLARA expansion cohorts will be a critical step toward achieving that goal, allowing us to characterize drug activity across a diversity of targeted therapy pretreated and targeted therapy naive patient populations.”

“The increasing diversity of EGFR mutations has led to a growing number of therapeutic agents targeting various, narrowly defined subsets of EGFR mutation-positive lung cancer. When designing BH-30643, we pursued a different and broader ambition - a highly potent drug capable of inhibiting a wide spectrum of EGFR mutations, while sparing inhibition of wildtype EGFR and HER2, expected to provide a significant survival benefit and a better tolerated therapy for more patients," said J. Jean Cui, Ph.D., President and Chief Executive Officer of BlossomHill Therapeutics. “With this goal top of mind, we sought to break away from the entrenched thinking present in prior generations of EGFR inhibitor designs. With BH-30643, we seek to address the ongoing unmet medical need for this disease in a safe and effective manner, and we are committed to the rapid advancement of our OMNI-EGFR^TM inhibitor in the clinic."