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Business Wire
5 days ago
- Business
- Business Wire
Bayer and Kumquat Biosciences Enter Global Exclusive License and Collaboration in Precision Oncology
BERLIN & SAN DIEGO--(BUSINESS WIRE)--Bayer and Kumquat Biosciences Inc., a clinical-stage biotech company founded by pioneers of the KRAS pathway, today announced that they have entered into an exclusive global license and collaboration to develop and commercialize Kumquat's KRAS G12D inhibitor. Under the agreement, Kumquat is responsible for the initiation and completion of the Phase Ia study, while Bayer will complete development and commercial activities. Kumquat received U.S. Food and Drug Administration (FDA) clearance of the investigational new drug (IND) for its KRAS G12D inhibitor in July 2025. Under the terms of the agreement, Kumquat will receive up to $1.3 billion, including upfront, clinical and commercial milestones, and additional tiered royalties on net sales. Kumquat retains an exclusive option to negotiate for participating in profit-loss sharing in the US. 'We are constantly evaluating innovative approaches to improve outcomes for patients, focusing on areas of high unmet medical need,' said Juergen Eckhardt, M.D., Head of Business Development and Licensing at Bayer's Pharmaceuticals Division. 'We look forward to collaborating with Kumquat, an accomplished team of experts with deep KRAS insights. Our intent is to explore the development of a potential new treatment option for patients, while further complementing Bayer's robust early precision oncology pipeline.' Oncogenic driver mutations, such as KRAS mutations, are changes in the DNA of genes that drive the development and growth of cancer. These mutations are often identified as key targets for cancer treatment, and their identification offers the opportunity to develop target-specific drugs. KRAS G12D mutations are found most frequently in 37 percent of pancreatic ductal adenocarcinoma (PDAC), 13 percent of colorectal cancer and 4 percent of non-small cell lung cancers. 2 PDAC is the most common type of pancreatic cancer (accounting for 85 percent of cases) and remains one of the most difficult tumors to treat, with patients having few treatment options beyond chemotherapy and the five-year survival rate being less than 10 percent. 3 Pancreatic cancer is the sixth leading cause of cancer-related death worldwide. 4 The incidence continues to rise annually, with projections indicating a 95.4 percent increase in new cases by 2050, potentially reaching a total of 998,663 new cases globally. 4 'KRAS mutations are crucial for cancer development and can be targeted with specific therapies in a more selective manner,' said Dominik Ruettinger, M.D., Ph.D., Global Head of Research and Early Development for Oncology at Bayer's Pharmaceuticals Division. 'KRAS mutations occur in nearly 25 percent of human cancers, yet the most prevalent and oncogenic KRAS (G12D) variant still lacks effective treatment options. We look forward to exploring the investigational KRAS G12D inhibitor, which targets a highly relevant signaling pathway that promotes tumor growth and survival.' 'Since pioneering the direct targeting of KRAS G12C mutation over a decade ago, we have continued to discover innovative strategies to target other KRAS mutants, including KRAS G12D,' said Yi Liu, Chief Executive Officer of Kumquat. 'Advancing our novel KRAS G12D asset into the clinic reflects our commitment to delivering durable therapies for KRAS patients suffering from deadly malignancies such as pancreatic, lung and colorectal cancers. This collaboration with Bayer validates the strength of our platform and the potential of our KRAS G12D candidate to address long-standing unmet needs in oncology. We are thrilled to collaborate with Bayer, who shares our vision and strategy for realizing the benefit of small molecule-based transformative treatments. While advancing optimally our KRAS G12D program through the clinic, this collaboration provides Kumquat the financial resources to accelerate its broader clinical pipeline for long-term value, and position Kumquat to deliver life-changing medicines and achieve sustained growth in the coming years.' About Kumquat Biosciences 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. 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 About Bayer 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. 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. R&D expenses amounted to 6.2 billion euros. For more information, go to Find more information at Follow us on Facebook: ak (2025-0140e) Forward-Looking Statements 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. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. 1 Cox AD, Fesik SW, Kimmelman AC, Luo J, Der CJ. Drugging the undruggable RAS: Mission possible? Nat Rev Drug Discov. 2014 Nov;13(11):828-51. doi: 10.1038/nrd4389. Epub 2014 Oct 17. PMID: 25323927; PMCID: PMC4355017. 2 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/ Epub 2021 Jul 22. PMID: 34303932. 3 Tonini V, Zanni M. Pancreatic cancer in 2021: What you need to know to win. World J Gastroenterol 2021; 27(35): 5851-5889 URL: 4 Leiphrakpam PD, Chowdhury S, Zhang M, Bajaj V, Dhir M, Are C. Trends in the Global Incidence of Pancreatic Cancer and a Brief Review of its Histologic and Molecular Subtypes. J Gastrointest Cancer. 2025 Feb 24;56(1):71. doi: 10.1007/s12029-025-01183-2. PMID: 39992560.
Business Wire
29-04-2025
- Business
- Business Wire
Bayer Initiates Phase I Study Targeting GPC3 With Actinium-225 Radiopharmaceutical in Patients With Advanced Hepatocellular Carcinoma
WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer announced today initiation of a Phase I clinical trial with 225 Ac-GPC3 (BAY 3547926), an investigational targeted alpha radiopharmaceutical being developed to treat tumors expressing Glypican-3 (GPC3) in patients with advanced hepatocellular carcinoma (HCC). Oncofetal protein GPC3 is a membrane-associated proteoglycan which is overexpressed in 70-75% of HCC lesions making it an attractive target for targeted radionuclide therapy. 1,2 The first-in-human, dose escalation study (NCT06764316) will evaluate the safety, tolerability and preliminary efficacy of BAY 3547926 alone, and as a combination therapy in patients with advanced HCC. 'Hepatocellular carcinoma continues to be a devastating disease for millions of patients and a pressing unmet need in cancer care. The launch of the Phase I trial using the 225 Ac-GPC3 radionuclide therapy marks an important milestone in our commitment to develop new medicines targeting cancer cells with high effect size and precision to improve the lives of people living with cancer,' said Dominik Ruettinger, M.D., Ph.D., Global Head of Research and Early Development for Oncology at Bayer's Pharmaceuticals Division. 'Through continued research innovation we can unlock the full potential of targeted alpha therapies which is an emerging class of targeted radionuclide therapy and a strategic focus area for Bayer's precision oncology development portfolio.' Liver cancer, including hepatocellular carcinoma, is the third leading cause of cancer-related deaths in the world with almost 900,000 new cases annually. 3 It is the most rapidly growing cause of cancer deaths in the US accounting for approximately 2% of new cases and 5% of cancer deaths. 4 Despite recent scientific advancements, many doctors are not satisfied with the therapeutic benefits from the currently available treatments. Targeted alpha therapy (TAT) has the potential to address high unmet medical need across various cancer types. Bayer's growing TAT portfolio combines alpha particle-emitting radionuclides with different targeting moieties. 225 Ac-GPC3 is the third TAT program in clinical development and the first investigational targeted radiopharmaceutical for Bayer in HCC. The newly disclosed targeted alpha conjugate joins 225 Ac-Pelgifatamab and 225 Ac-PSMA-Trillium, which are currently in Phase I clinical trials in patients with advanced metastatic castration resistant prostate cancer. On April 28, 2025 Bayer introduced 225 Ac-GPC3 in an oral presentation during the 'New Drugs on the Horizon' session at the AACR (American Association of Cancer Research) Annual Meeting, showcasing preclinical characterization of the asset including the low uptake and fast clearance from normal organs as well as induction of tumor regression in in vivo models. Recognition in this special symposium highlights the company's commitment for precision oncology development portfolio. 1 Kolluri A and Ho M (2019), The Role of Glypican-3 in Regulating Wnt, YAP, and Hedgehog in Liver Cancer. Front. Oncol. 9:708. doi: 10.3389/fonc.2019.00708. 2 Yongle Wu, Hui Liu, Huiguo Ding, GPC-3 in hepatocellular carcinoma: current perspectives, Journal of Hepatocellular Carcinoma 2016:3, 63-67. 3 Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries, Freddie Bray BSc, MSc, PhD; Mathieu Laversanne MSc; Hyuna Sung PhD; Jacques Ferlay ME; Rebecca L. Siegel MPH; Isabelle Soerjomataram MD, MSc, PhD; Ahmedin Jemal DVM, PhD. 4 SEER Cancer Stat Facts: Liver and Intrahepatic Bile Duct Cancer. National Cancer Institute. Bethesda, MD, Expand About BAY 3547926 BAY 3547926 is an investigational targeted alpha radiopharmaceutical being developed to treat tumors expressing Glypican-3 (GPC3) in patients with advanced hepatocellular carcinoma (HCC). It is composed of a GPC3 targeting high affinity antibody radiolabeled with actinium-225 (225 Ac). 225 Ac-GPC3 delivers highly potent alpha-particles to the GPC3-expressing cancer cells, with the potential to inducing DNA double-strand breaks, reducing cancer cell viability which may potentially cause anti-tumor activity. About Targeted Alpha Therapy Targeted alpha therapy (TAT) is an emerging class of radionuclide therapy that can be used against a variety of tumors. It delivers alpha particle radiation directly to the tumor inside the body, either via its bone-seeking property (radium-223) or by combining alpha radionuclides, such as actinium-225, with specific targeting moieties. Actinium-225 is an alpha particle–emitting radionuclide with a 9.9-day half-life. Alpha particles deposit highly ionizing radiation over a short range. This localized delivery of the radioactive payload induces irreparable DNA double-strand breaks, often resulting in cell death. At the same time, because the energy travels a short range, damage to nearby normal tissues is much reduced. 5,6,7 About Oncology at Bayer 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. 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. About Bayer 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. 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. R&D expenses amounted to 6.2 billion euros. For more information, go to Find more information at Follow us on Facebook: Forward-Looking Statements 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. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
