SAN DIEGO, Oct. 24, 2025 (GLOBE NEWSWIRE) -- 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.”
The poster presentation will be made available on the BlossomHill Therapeutics website at https://bhtherapeutics.com/pipeline/#posters-presentations.
About the Phase 1/2 SOLARA Trial
SOLARA is a global, open label, Phase 1/2 clinical trial designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) bearing EGFR and/or HER2 mutations. The expansion cohorts of the SOLARA trial assess single-agent objective response rate (ORR) of BH-30643 in NSCLC patients with diverse EGFR mutations, including patients with classical and atypical EGFR mutations (whether or not they have received prior EGFR targeted therapy). For additional information on SOLARA, including a list of study sites and how to enroll, please visit at clinicaltrials.gov (NCT06706076).
About BH-30643
BH-30643 is a first-in-class, macrocyclic, non-covalent, mutant selective OMNI-EGFR™ inhibitor designed for super-potency against a broad spectrum of mutations in the EGFR kinase domain, including EGFR classical mutations and atypical mutations (such as PACC mutations and beyond), diverse EGFR resistant mutations (such as C797S +/- T790M), and other types of mutations. BH-30643 is also designed to spare wild type EGFR and HER2 inhibition (and associated toxicity) through selective targeting of the active conformation of the kinases. BH-30643 is currently being evaluated in the Phase 1/2 SOLARA clinical trial in patients with locally advanced or metastatic NSCLC bearing EGFR and/or HER2 mutations.
About BlossomHill Therapeutics
BlossomHill Therapeutics, Inc. is a privately held, clinical-stage biopharmaceutical company focused on designing and developing next-generation targeted therapies for cancer. Founded and led by industry veterans with a proven track record in oncology drug discovery and development – including multiple FDA-approved therapies – BlossomHill applies cutting-edge science to address key oncogenic drivers and improve patient outcomes in difficult-to-treat cancers. The company’s lead clinical programs include BH-30643, a first-in-class, macrocyclic, non-covalent, mutant selective OMNI-EGFR™ inhibitor for the treatment of EGFR- or HER2-mutated non-small cell lung cancer (NSCLC), and BH-30236, a macrocyclic CLK inhibitor for the treatment of relapsed or refractory acute myeloid leukemia (AML) or higher-risk myelodysplastic syndrome (HR-MDS), representing a first-in-class opportunity. BlossomHill Therapeutics is headquartered in San Diego, California and is supported by leading life sciences investors, including Cormorant Asset Management, OrbiMed, Vivo Capital and Colt Ventures. For more information, visit bhtherapeutics.com and follow us on LinkedIn and X.
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