BH-30643 is a macrocyclic, mutant selective OMNI-EGFR™ inhibitor with sub-nanomolar potency against classical and atypical EGFR mutations that is maintained even in the presence of T790M +/- C797S resistance mutations
SAN DIEGO, CA, USA I January 22, 2025 I 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 cohort of patients has been dosed in the SOLARA study (NCT06706076). SOLARA is a global, open label, dose escalation and expansion Phase 1/2 clinical trial assessing the safety, efficacy and tolerability of BH-30643 for locally advanced or metastatic non-small cell lung cancer (NSCLC) bearing EGFR or HER2 mutations.
“EGFR-mutant lung cancer is one of the most common genomic subtypes of lung cancer globally and has been a major target of drug development in recent years, yet an unmet medical need remains for patients,” said Dr. Geoff Oxnard, Chief Medical Officer of BlossomHill Therapeutics. “Our thesis is that the novel, macrocyclic design of BH-30643 will provide potent antitumor activity in a broader spectrum of EGFR-mutant lung cancers with reduced toxicity. Dosing the first Phase 1 patient cohort with BH-30643, our second molecule to enter the clinic, marks an important step toward our goal of providing patients with intentionally designed precision medicines.”
About the SOLARA study
The Phase 1/2 SOLARA clinical trial evaluates BH-30643, a macrocyclic, reversible, mutant-selective OMNI-EGFR™ inhibitor for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) bearing EGFR or HER2 mutations. In preclinical studies, BH-30643 demonstrated potent antitumor activity spanning classical EGFR mutations (exon 19 deletions, L858R), atypical EGFR mutations (G719X, L861Q, S768I, etc.), exon 20 insertions, and HER2 mutations. The global study consists of a dose escalation part to identify Recommended Doses for Evaluation (RDE), followed by an expansion part to further evaluate BH-30643 across a range of EGFR and HER2 mutations. Additional details on the design and discovery of BH-30643 will be reported at an upcoming medical meeting.
About Blossom Hill Therapeutics
BlossomHill Therapeutics, Inc. is a small molecule drug design and development company focused on addressing unmet medical needs in oncology and autoimmune diseases. The company is building a deep pipeline of candidates across a range of targets with the aim of making the next leap forward in treatment for patients. The company’s approach to drug design and development first considers the unmet medical need through deep knowledge of the science behind the disease, and then seeks to design a novel chemotype to provide the best chance of success. BlossomHill’s first two clinical programs are BH-30236 for the treatment of relapsed or refractory AML or HR-MDS and BH-30643 for the treatment of EGFR- or HER2-mutated NSCLC. Headquartered in San Diego, California, BlossomHill Therapeutics is supported by a strong syndicate of leading investors, including Cormorant Asset Management, OrbiMed, Vivo Capital and Colt Ventures. For more information, visit bhtherapeutics.com and follow us on LinkedIn and X.
SOURCE: Blossom Hill Therapeutics
Post Views: 87
BH-30643 is a macrocyclic, mutant selective OMNI-EGFR™ inhibitor with sub-nanomolar potency against classical and atypical EGFR mutations that is maintained even in the presence of T790M +/- C797S resistance mutations
SAN DIEGO, CA, USA I January 22, 2025 I 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 cohort of patients has been dosed in the SOLARA study (NCT06706076). SOLARA is a global, open label, dose escalation and expansion Phase 1/2 clinical trial assessing the safety, efficacy and tolerability of BH-30643 for locally advanced or metastatic non-small cell lung cancer (NSCLC) bearing EGFR or HER2 mutations.
“EGFR-mutant lung cancer is one of the most common genomic subtypes of lung cancer globally and has been a major target of drug development in recent years, yet an unmet medical need remains for patients,” said Dr. Geoff Oxnard, Chief Medical Officer of BlossomHill Therapeutics. “Our thesis is that the novel, macrocyclic design of BH-30643 will provide potent antitumor activity in a broader spectrum of EGFR-mutant lung cancers with reduced toxicity. Dosing the first Phase 1 patient cohort with BH-30643, our second molecule to enter the clinic, marks an important step toward our goal of providing patients with intentionally designed precision medicines.”
About the SOLARA study
The Phase 1/2 SOLARA clinical trial evaluates BH-30643, a macrocyclic, reversible, mutant-selective OMNI-EGFR™ inhibitor for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) bearing EGFR or HER2 mutations. In preclinical studies, BH-30643 demonstrated potent antitumor activity spanning classical EGFR mutations (exon 19 deletions, L858R), atypical EGFR mutations (G719X, L861Q, S768I, etc.), exon 20 insertions, and HER2 mutations. The global study consists of a dose escalation part to identify Recommended Doses for Evaluation (RDE), followed by an expansion part to further evaluate BH-30643 across a range of EGFR and HER2 mutations. Additional details on the design and discovery of BH-30643 will be reported at an upcoming medical meeting.
About Blossom Hill Therapeutics
BlossomHill Therapeutics, Inc. is a small molecule drug design and development company focused on addressing unmet medical needs in oncology and autoimmune diseases. The company is building a deep pipeline of candidates across a range of targets with the aim of making the next leap forward in treatment for patients. The company’s approach to drug design and development first considers the unmet medical need through deep knowledge of the science behind the disease, and then seeks to design a novel chemotype to provide the best chance of success. BlossomHill’s first two clinical programs are BH-30236 for the treatment of relapsed or refractory AML or HR-MDS and BH-30643 for the treatment of EGFR- or HER2-mutated NSCLC. Headquartered in San Diego, California, BlossomHill Therapeutics is supported by a strong syndicate of leading investors, including Cormorant Asset Management, OrbiMed, Vivo Capital and Colt Ventures. For more information, visit bhtherapeutics.com and follow us on LinkedIn and X.
SOURCE: Blossom Hill Therapeutics
Post Views: 87
