拜耳和金橘生物科学公司在KRAS突变肿瘤患者中启动KRAS G12D抑制剂的I期研究-动脉网

Bayer and Kumquat Biosciences initiate Phase：study with KRAS G12D inhibitor in patients with KRAS-mutated tumors

拜耳等信源发布 2025-10-08 20:04

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October

十月

2025

14:00 PM

Europe/Amsterdam

欧洲/阿姆斯特丹

Bayer and Kumquat Biosciences initiate Phase I study with KRAS G12D inhibitor in patients with KRAS-mutated tumors

拜耳和金橘生物科学公司在KRAS突变肿瘤患者中启动KRAS G12D抑制剂的I期研究

Not intended for UK Media

不适用于英国媒体

Summary

摘要

First patients enrolled in Phase I trial with KQB548 (BAY 3771249), an investigational KRAS inhibitor designed to treat KRAS G12D-mutated tumors / KRAS mutations occur in nearly 25 percent of human cancers, with the most prevalent and oncogenic KRAS (G12D) variant still lacking effective treatment options.

首批患者已入组KQB548（BAY 3771249）的I期临床试验，这是一种在研的KRAS抑制剂，旨在治疗KRAS G12D突变肿瘤 / KRAS突变发生在近25%的人类癌症中，其中最普遍且致癌的KRAS（G12D）变异仍然缺乏有效的治疗选择。

/ Innovative drug development candidate strengthens Bayer’s precision oncology development portfolio in the areas of pancreatic, colorectal and lung cancer

/ 创新药物开发候选者加强了拜耳在胰腺癌、结直肠癌和肺癌领域的精准肿瘤开发组合

Berlin, Germany and San Diego, USA, October 8, 2025

德国柏林，美国圣地亚哥，2025年10月8日

– Bayer and Kumquat Biosciences Inc., a clinical-stage biotech company founded by pioneers of targeting the KRAS pathway, announced today the initiation of a Phase I clinical trial with KQB548 (BAY 3771249), an investigational inhibitor designed to treat KRAS G12D-mutated tumors, such as pancreatic, colorectal and lung cancer.

– 拜耳和由KRAS通路靶向治疗先驱创立的临床阶段生物技术公司Kumquat Biosciences Inc.今天宣布启动一项I期临床试验，测试KQB548（BAY 3771249），这是一种旨在治疗KRAS G12D突变肿瘤（如胰腺癌、结直肠癌和肺癌）的在研抑制剂。

The first-in-human, dose-escalation study (.

人体首次剂量递增研究（。

NCT07207707

) will evaluate the safety and preliminary efficacy of KQB548 (BAY 3771249) as a monotherapy in patients with KRAS G12D mutated tumors. KRAS mutations occur in nearly 25 percent of human cancers, yet the most prevalent and oncogenic KRAS variant (G12D) still lacks effective treatment options.

）将评估KQB548（BAY 3771249）作为单药治疗在KRAS G12D突变肿瘤患者中的安全性和初步疗效。KRAS突变发生在近25%的人类癌症中，然而最常见的致癌KRAS变异体（G12D）仍然缺乏有效的治疗选择。

“Initiating clinical development of investigational KRAS G12D inhibitor KQB548 (BAY 3771249) marks an important milestone in our commitment to develop new medicines targeting highly relevant signaling pathways that promote tumor growth and survival,” said Dominik Ruettinger, M.D., Ph.D., Global Head of Research and Early Development for Oncology at Bayer’s Pharmaceuticals Division.

“启动KRAS G12D抑制剂KQB548（BAY 3771249）的临床开发标志着我们在致力于开发针对高度相关信号通路、促进肿瘤生长和存活的新药物方面迈出了重要的一步，”拜耳制药部门肿瘤学全球研究与早期开发负责人Dominik Ruettinger博士表示。

“Targeting KRAS has been considered quite challenging. We aim to deliver treatment options for patients with cancers driven by the KRAS G12D mutation. Through continued research innovation we can unlock the potential of precision oncology and improve the lives of people living with cancer.”.

“针对KRAS的治疗一直被认为具有相当大的挑战性。我们的目标是为携带KRAS G12D突变的癌症患者提供治疗选择。通过持续的研究创新，我们可以释放精准肿瘤学的潜力，改善癌症患者的生活。”

KRAS G12D mutations are found most frequently in approximately 37 percent of pancreatic ductal adenocarcinoma (PDAC), 13 percent of colorectal cancer and 4 percent of non-small cell lung cancers.

KRAS G12D 突变在大约 37% 的胰腺导管腺癌 (PDAC)、13% 的结直肠癌和 4% 的非小细胞肺癌中最为常见。

These mutations are often recognized as important targets for cancer treatment, and their detection paves the way for the creation of tailored therapies.

这些突变通常被认为是癌症治疗的重要靶点，其检测为制定个性化疗法铺平了道路。

Despite recent scientific advancements, there are currently no effective treatments available that provide durable therapeutic benefits for most patients with KRAS-G12D-mutated cancers. Introducing the KRAS G12D inhibitor into clinical trials aims to address the long-standing unmet need.

尽管近期科学有所进步，但目前尚无有效的治疗方法能够为大多数KRAS G12D突变癌症患者提供持久的治疗益处。将KRAS G12D抑制剂引入临床试验旨在解决这一长期未满足的需求。

“We are excited to initiate the clinical trial of our KRAS G12D inhibitor KQB548, which holds the prospect of transforming the KRAS G12D treatments for the deadly malignancies such as pancreatic, lung and colorectal cancers,” said Dr. Nicolas Acquavella, Senior Vice President of Clinical Development and Corporate Alliance Management of Kumquat.

“我们很高兴启动我们的KRAS G12D抑制剂KQB548的临床试验，这款药物有望改变KRAS G12D在胰腺癌、肺癌和结直肠癌等致命恶性肿瘤中的治疗前景，” Kumquat临床开发和企业联盟管理高级副总裁Nicolas Acquavella博士表示。

“The speedy enrollment highlights our team’s execution capabilities and Kumquat’s long-standing commitment to .

“快速的注册过程突显了我们团队的执行能力以及金橘长期以来对的承诺。

delivering potentially life-changing medicines to cancer patients.

为癌症患者提供可能改变生命的药物。

”

“”

About KRAS G12D inhibitor (KQB548 – BAY 3771249)

关于KRAS G12D抑制剂（KQB548 – BAY 3771249）

KQB548 (BAY 3771249) is an investigational KRAS G12D inhibitor being developed to treat KRAS-mutated tumors, such as pancreatic, colorectal and lung cancer. KQB548 (BAY 3771249) is the lead program from the Bayer and Kumquat global exclusive license and collaboration in precision oncology. Kumquat received U.S.

KQB548（BAY 3771249）是一种正在开发中的KRAS G12D抑制剂，用于治疗KRAS突变的肿瘤，如胰腺癌、结直肠癌和肺癌。KQB548（BAY 3771249）是拜耳和金橘生物在全球精准肿瘤学领域独家许可与合作中的主要项目。金橘生物已获得美国授权。

Food and Drug Administration (FDA) clearance of the investigational new drug (IND) for its KRAS G12D inhibitor in July 2025..

2025年7月，KRAS G12D抑制剂的研究性新药（IND）获得食品药品监督管理局（FDA）的批准。

About Oncology at Bayer

关于拜耳的肿瘤学

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. The oncology franchise at Bayer includes several marketed products across diverse indications and multiple compounds in different stages of clinical development.

拜耳致力于通过推进一系列创新治疗方案来为更美好的生活提供科学支持。公司充满热情和决心，开发能够帮助改善和延长癌症患者生命的新药。拜耳的肿瘤学产品组合包括多种已上市的产品，涵盖不同的适应症，同时还有多个化合物处于临床开发的不同阶段。

We have a wealth of expertise in areas including Tumor Cell Intrinsic Pathways, Targeted Radionuclide Therapies, and selective Next-Generation Immuno-Oncology. With our portfolio we are advancing cancer treatments from early to metastatic stage, with the goal of extending survival while limiting side effects for the cancer patients we serve..

我们在肿瘤细胞内在通路、靶向放射性核素治疗和选择性下一代免疫肿瘤学等领域拥有丰富的专业知识。通过我们的产品组合，我们正在推动癌症治疗从早期到转移阶段的发展，目标是延长患者的生存期，同时减少所服务癌症患者的副作用。

About Bayer

关于拜耳

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

拜耳是一家在全球医疗保健和营养等生命科学领域拥有核心竞争力的企业。秉承“人人健康，无饥饿”的使命，公司通过支持应对不断增长和老龄化的全球人口所带来的重大挑战，设计其产品和服务以帮助人类和地球繁荣发展。

Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros.

拜耳致力于通过其业务推动可持续发展并产生积极影响。同时，集团旨在通过创新和增长提高盈利能力并创造价值。拜耳品牌在全球范围内代表信任、可靠性和质量。在2024财年，集团拥有约93,000名员工，销售额达466亿欧元。

R&D expenses amounted to 6.2 billion euros. For more information, go to .

研发费用总计达62亿欧元。欲了解更多信息，请访问。

www.bayer.com

。

About Kumquat Biosciences

关于金橘生物科学

Kumquat Biosciences is a privately held drug discovery and development company committed to creating life-changing medicines for cancer patients. The company focuses on translating breakthrough science into first-in-class therapeutics. Kumquat brings together an accomplished team and distinguished scientific founder with a proven track record of innovative oncology drug discovery and development.

金橘生物科学是一家私人持有的药物发现与开发公司，致力于为癌症患者创造改变生命的药物。该公司专注于将突破性科学转化为首创的治疗方法。金橘汇聚了一支成就卓著的团队和杰出的科学创始人，他们在创新肿瘤药物的发现和开发方面有着可靠的记录。

The company launched in 2019 and was funded by OrbiMed, HSG, EcoR1, Lilly Asia Ventures, Roche Venture Fund, and Boxer Capital, and previously entered two major collaborations with Eli Lilly and Takeda. For more information, please visit .

该公司于2019年成立，由OrbiMed、HSG、EcoR1、礼来亚洲风险投资、罗氏风险基金和Boxer Capital提供资金支持，并且之前与礼来和武田达成了两项重大合作。欲了解更多信息，请访问。

www.kumquatbiosciences.com

。

Find more information at

更多信息请访问

https://pharma.bayer.com

关注我们的Facebook：

http://www.facebook.com/bayer

Forward-Looking Statements

前瞻性声明

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here.

本发布可能包含基于拜耳管理层当前假设和预测的前瞻性声明。各种已知和未知的风险、不确定性和其他因素可能导致公司的实际未来结果、财务状况、发展或业绩与这里提供的估计值存在重大差异。

These factors include those discussed in Bayer’s public reports which are available on the Bayer website at .

这些因素包括拜耳公开报告中讨论的内容，这些报告可在拜耳网站上查阅。

www.bayer.com

. The company assumes no liability whatsoever to update these forward-looking statements or to conform

公司不承担更新这些前瞻性声明或使其符合的任何责任 whatsoever

them to future events or developments.

将它们应用于未来的事件或发展。

Singhal, A., Li, B.T. & O’Reilly, E.M. Targeting KRAS in cancer.

Singhal, A., Li, B.T. & O’Reilly, E.M. 靶向癌症中的KRAS。

Nat Med

自然医学

, 969–983 (2024).

，969-983页（2024年）。

https://doi.org/10.1038/s41591-024-02903-0

Herdeis L, Gerlach D, McConnell DB, Kessler D. Stopping the beating heart of cancer: KRAS reviewed. Curr Opin Struct Biol. 2021 Dec;71:136-147. doi: 10.1016/j.sbi.2021.06.013. Epub 2021 Jul 22. PMID: 34303932.

Herdeis L, Gerlach D, McConnell DB, Kessler D. 停止癌症的跳动之心：KRAS综述。《当代结构生物学观点》。2021年12月；71卷：136-147页。doi: 10.1016/j.sbi.2021.06.013。电子版发表于2021年7月22日。PMID: 34303932。

Bayer Global Media Contact:

拜耳全球媒体联系人：

Anna Kanmaz, phone +49 174 146 3541

安娜·坎马兹，电话 +49 174 146 3541

Email:

电子邮件：

anna.kanmaz@bayer.com

安娜.康玛兹@拜耳.com

Bayer US Media Contact

拜耳美国媒体联系人

：

Elaine Colon, phone +1 732 236 1587