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 (

BlossomHill Therapeutics, Inc.，一家私营的临床阶段生物技术公司，专注于设计和开发用于治疗癌症和自身免疫性疾病的小分子药物，今天宣布第一批患者已在SOLARA研究中服用(

NCT06706076

型号：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.

)。SOLARA是一项全球性，开放标签，剂量递增和扩展的1/2期临床试验，评估BH-30643对携带EGFR或HER2突变的局部晚期或转移性非小细胞肺癌（NSCLC）的安全性，有效性和耐受性。

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. “

EGFR突变型肺癌是全球最常见的肺癌基因组亚型之一，近年来一直是药物开发的主要目标，但患者的医疗需求仍未得到满足，”Bloomhill Therapeutics首席医疗官杰夫·奥克斯纳德博士说。“”

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.”.

我们的论文是，BH-30643的新型大环设计将在更广泛的EGFR突变肺癌中提供有效的抗肿瘤活性，并降低毒性。给第一阶段1患者队列服用BH-30643，这是我们进入临床的第二种分子，标志着我们朝着为患者提供精心设计的精准药物的目标迈出了重要的一步。”。

About the SOLARA study

关于SOLARA研究

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.

1/2期SOLARA临床试验评估了BH-30643，一种大环，可逆，突变选择性OMNI-EGFR™抑制剂，用于局部晚期或转移性非小细胞肺癌（NSCLC）携带EGFR或HER2突变的患者。在临床前研究中，BH-30643表现出跨越经典EGFR突变（外显子19缺失，L858R），非典型EGFR突变（G719X，L861Q，S768I等），外显子20插入和HER2突变的有效抗肿瘤活性。

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..

全球研究包括剂量递增部分，以确定推荐的评估剂量（RDE），然后是扩展部分，以进一步评估一系列EGFR和HER2突变的BH-30643。关于BH-30643的设计和发现的更多细节将在即将举行的医学会议上报告。。

About Blossom Hill Therapeutics

关于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.

Bloomhill Therapeutics，Inc.是一家小分子药物设计和开发公司，专注于解决肿瘤学和自身免疫性疾病中未满足的医疗需求。该公司正在一系列目标上建立一个深入的候选人渠道，目的是在患者治疗方面取得下一个飞跃。

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.

该公司的药物设计和开发方法首先通过对疾病背后科学的深入了解来考虑未满足的医疗需求，然后寻求设计一种新型化学型以提供最佳的成功机会。Bloomhill的前两个临床项目是用于治疗复发或难治性AML或HR-MDS的BH-30236和用于治疗EGFR或HER2突变的NSCLC的BH-30643。

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 .

Bloomhill Therapeutics总部位于加利福尼亚州圣地亚哥，由领先投资者组成的强大财团提供支持，包括Cormorant Asset Management、OrbiMed、Vivo Capital和Colt Ventures。有关更多信息，请访问。