*October 2025*
BlossomHill Therapeutics, Inc., a privately-held, a clinical-stage biopharmaceutical company focused on the design and development of next-generation medicines for cancer, today presented preliminary findings from the dose escalation portion of the company’s ongoing, first-in-human Phase 1/2 SOLARA trial of BH-30643 in patients with locally advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC) at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. BH-30643 is a first-in-class, macrocyclic, non-covalent, mutant selective OMNI-EGFR™ inhibitor designed for super-potency against a broad spectrum of EGFR mutations, including EGFR classical mutations and atypical mutations (such as PACC mutations and beyond), diverse EGFR resistant mutations (such as C797S and/or T790M), and other types of mutations.
“We are very encouraged by these early dose escalation findings from the ongoing SOLARA trial, which begin to demonstrate the potential of our OMNI-EGFR™ inhibitor, BH-30643, to overcome the resistance limitations of contemporary EGFR inhibitors,” said Geoff Oxnard, M.D., Chief Medical Officer of BlossomHill Therapeutics. “Current EGFR inhibitors often fall short due to factors such as inadequate potency, targeting only a narrow slice of mutations, or having a vulnerability to resistance mutations which shorten the duration of benefit. By potently inhibiting a broad spectrum of classical, atypical and resistant EGFR mutations, BH-30643 holds the potential to become an important advancement in the treatment of EGFR-mutant NSCLC. Enrollment of both targeted therapy naive and pretreated patients is ongoing into expansion cohorts to further characterize the promising clinical profile of BH-30643.”
As of the cut-off date of August 28, 2025, 39 patients with previously treated EGFR-mutant NSCLC were enrolled into the Phase 1 dose escalation portion of the ongoing SOLARA trial across dose cohorts ranging from 20 mg to 160 mg total daily dose of BH-30643. High plasma exposures were observed, well exceeding target EC90 at candidate doses, and comparing favorably with the exposures seen with contemporary EGFR inhibitors. The poster presentation highlights several case examples showing tumor reductions in heavily pretreated EGFR-mutant NSCLC patients, including those with complex and difficult-to-treat mutations such as C797S + exon 19 deletion, C797S + T790M + exon 19 deletion, G724A + exon 19 deletion, T790M + exon 20 insertion, and exon 20 insertion with brain metastases.
“BH-30643 stands out with its fundamentally novel macrocyclic architecture,” said J. Jean Cui, Ph.D., President and Chief Executive Officer of BlossomHill Therapeutics. “In contrast to many current EGFR inhibitors that repurpose chemical scaffolds from earlier generations, BH-30643 was purpose-built to potently, selectively, and non-covalently target a broad range of EGFR mutations—including those driving resistance to current therapies. We believe this compound represents a significant leap forward in oncology drug design, and we look forward to sharing more findings from the Phase 1/2 SOLARA trial in 2026.” Read more.
