TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics (“BBOT” or the “Company”), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BBO-8520, an investigational oral therapy for the treatment of adult patients with previously treated, KRAS.

TheRas，Inc.d/b/a BridgeBio Oncology Therapeutics（“BBOT”或“公司”）是一家专注于RAS途径恶性肿瘤的临床阶段生物制药公司，今天宣布，美国食品和药物管理局（FDA）已授予BBO-8520快速通道指定，BBO-8520是一种研究性口服疗法，用于治疗先前接受过KRAS治疗的成年患者。

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-mutated metastatic non-small cell lung cancer (NSCLC).

-突变的转移性非小细胞肺癌（NSCLC）。

BBO-8520 is designed to inhibit the “ON and OFF” state to provide optimal target coverage and to address KRAS

BBO-8520旨在抑制“开和关”状态，以提供最佳的目标覆盖率并解决KRAS问题

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amplification and receptor tyrosine kinase activation – the two key mechanisms of adaptive resistance to current “OFF” state inhibitors. It drives substantial tumor growth inhibition in multiple preclinical models, even after emergence of resistance to sotorasib, an FDA approved “OFF” state inhibitor of KRAS.

扩增和受体酪氨酸激酶激活-对当前“关闭”状态抑制剂产生适应性抗性的两个关键机制。它在多种临床前模型中驱动了实质性的肿瘤生长抑制，即使在对sotorasib（一种FDA批准的KRAS“关闭”状态抑制剂）产生耐药性之后也是如此。

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The discovery of BBO-8520 was the result of a collaboration between the National Cancer Institute RAS Initiative at Frederick National Laboratory for Cancer Research, Lawrence Livermore National Laboratory, and BBOT.

BBO-8520的发现是弗雷德里克国家癌症研究实验室国家癌症研究所RAS倡议，劳伦斯·利弗莫尔国家实验室和BBOT合作的结果。

“Receiving Fast Track designation for BBO-8520 is a significant milestone in our efforts to overcome the limitations of existing therapies for KRAS

“获得BBO-8520快速通道指定是我们努力克服KRAS现有疗法局限性的一个重要里程碑

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-mutant cancers,” said Yong Ben, MD, Chief Medical and Development Officer of BBOT. “BBO-8520 represents a first-in-class approach with potential to address high unmet medical needs and shift the paradigm for cancer treatment. We will continue to work closely with the FDA to expedite the development of BBO-8520, which is currently being evaluated in a Phase 1 study (.

-突变型癌症，”BBOT首席医疗和发展官Yong Ben医学博士说。“BBO-8520代表了一种一流的方法，有可能解决高度未满足的医疗需求并改变癌症治疗的模式。我们将继续与FDA密切合作，加快BBO-8520的开发，目前正在一项第一阶段研究中进行评估（。

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) of KRAS

)KRAS

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NSCLC patients pre-treated with first generation KRAS

第一代KRAS预处理的NSCLC患者

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“OFF” inhibitors or with no prior KRAS

“关闭”抑制剂或没有先前的KRAS

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targeted therapy experience.”

有针对性的治疗经验。”

Fast Track designation is intended to help rapidly advance the development and review process for promising therapeutic candidates for serious conditions that may fill an unmet medical need.

快速通道指定旨在帮助快速推进有希望的治疗候选人的开发和审查过程，以应对可能满足未满足医疗需求的严重疾病。

About TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics (BBOT)

关于TheRas，Inc.d/b/a BridgeBio Oncology Therapeutics（BBOT）

BridgeBio Oncology Therapeutics (BBOT) is a clinical-stage biopharmaceutical company advancing a next generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. Initially formed as a subsidiary of BridgeBio, BBOT completed a $200M private financing with external investors in 2024 with the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors.

BridgeBio Oncology Therapeutics（BBOT）是一家临床阶段的生物制药公司，致力于开发针对RAS和PI3K恶性肿瘤的新一代小分子治疗药物。BBOT最初是作为BridgeBio的子公司成立的，于2024年与外部投资者完成了2亿美元的私人融资，目标是改善由人类肿瘤中两种最普遍的致癌基因驱动的癌症患者的预后。