Bayer and Vividion to unveil breakthroughs in targeted cancer therapies at AACR 2025

Bayer and Vividion Therapeutics, Inc. will present the latest research on their advancing oncology portfolio at the upcoming American Association for Cancer Research (AACR) 2025 Annual Meeting, taking place from April 25-30, 2025, in Chicago, USA. Bayer will present preclinical data as well as clinical imaging results from its evolving portfolio of targeted alpha therapy, an emerging class of targeted radionuclide therapy and a focus of Bayer’s precision drug development strategy in oncology. In addition, the company will showcase encouraging preclinical and clinical research data on several compounds targeting intracellular tumor signaling pathways responsible for the development and survival of cancer, potentially offering new treatment opportunities in indications of high medical relevance. Vividion, a wholly owned and independently operating subsidiary of Bayer AG, will provide insights into the development and characterization of its highly selective small molecule KEAP1 activator, being evaluated as a new therapeutic means of blocking the oncogenic pathways.

During the “New Drugs on the Horizon” session, Bayer will introduce its investigational targeted alpha radiopharmaceutical (BAY 3547926) being developed to treat tumors expressing Glypican-3 (GPC3) in patients with advanced hepatocellular carcinoma (HCC). GPC3 is an oncofetal protein overexpressed in 70-75 percent of HCC lesions which makes it an attractive target for targeted radionuclide therapy.^1,2 This investigational radiotherapeutic delivers a highly potent alpha-particles to the GPC3-expressing cancer cells, aiming to induce DNA double-strand breaks and reduce cancer cell viability, which may potentially cause anti-tumor activity. The data presented will include preclinical in vitro and in vivo characterization, along with the results of a clinical imaging study in patients with advanced HCC.

From its focus area Precision Molecular Oncology, Bayer will present latest research on a novel targeted treatment option for patients with advanced non-small cell lung cancer (NSCLC) harboring HER2-activating mutations. Derived from its strategic research alliance with the Broad Institute of MIT and Harvard, the investigational HER2/mEGFR inhibitor sevabertinib (BAY 2927088) is the first oral, reversible small molecule targeting human epidermal growth factor receptor 2 (HER2). The ongoing Phase I/II SOHO-01 study is evaluating its safety and efficacy. Its potential is underscored by Breakthrough Therapy Designations from both the US FDA and Chinese Centre for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). Beyond the SOHO-01 trial, sevabertinib (BAY 2927088) is also being assessed for its potential as a first-line therapy in patients with advanced non-small cell lung cancer (NSCLC), whose tumors have activating HER2 mutations in the Phase III SOHO-02 trial.

Bayer will provide insights into the discovery and characterization of its investigational oral selective Son of Sevenless Homologue 1 (SOS1) inhibitor BAY 3498264, which is currently being evaluated in a Phase I clinical trial in patients with advanced KRAS-mutated tumors, such as non-small cell lung cancer (NSCLC), pancreatic cancer and colorectal cancer. This innovative clinical candidate with promising therapeutic potential across several tumor types, addresses the unmet medical need of improving efficacy of treatment targeting the mitogen-activated protein kinase (MAPK) signaling pathway which regulates cell proliferation and plays a critical role in tumor growth and carcinogenesis.

Another abstract will present a translational pharmacokinetic-pharmacodynamic (PK/PD) modeling framework of novel, highly selective, next-generation allosteric cyclin-dependent kinase 2 (CDK2) inhibitors. The amplification and overexpression of the CDK2 binding partner Cyclin E1 (CCNE1) is a key mechanism in various cancers, and selective CDK2/CCNE1 inhibition potentially offers a promising treatment for patients with CCNE1 overexpressing tumors. The use of state-of-the-art PKPD models is a valuable method for integrating multi-scale data to investigate the causal chain between dose and response. Consequently, the development of a model framework based on preclinical in vitro and in vivo data is of significant interest for the support of preclinical and clinical phases. Model evaluation and refinements based on clinical data will be key for further use during clinical development.

Vividion will be presenting a poster outlining translational pharmacokinetic / pharmacodynamic (PK/PD) modeling for its innovative covalent small molecule Kelch-like ECH-associated protein 1 (KEAP1) activator, VVD-037. KEAP1 is an E3 ligase that degrades NRF2, a master regulatory transcription factor that coordinates antioxidant, detoxification, and cytoprotective gene programs. NRF2 pathway hyper activation promotes malignant tumor growth and resistance to many standard-of-care therapies and is frequently detected in solid cancers such as non-small cell lung cancer, esophageal squamous cell carcinoma, and head and neck squamous cell carcinoma. VVD-037 is being evaluated in a Phase I clinical trial as a single agent and in combination.

Information on the registration as well as the virtual scientific program can be found here.

Key presentations on Bayer and Vividion research to be presented at AACR 2025 are listed below.

Oral presentation:

BAY 3547926: Novel targeted radionuclide therapy for hepatocellular carcinoma

o   Abstract ND09, Session: DDT03 – New Drugs on the Horizon: Part 3

o   Monday, April 28, 10:15 AM – 11:45 AM (AM), Room S406 (Vista Ballroom) – McCormick Place South (Level 4), Convention Center

Poster presentations:

A translational pharmacokinetic-pharmacodynamic (PKPD) modeling framework of novel, highly selective, next-generation allosteric cyclin-dependent kinase 2 (CDK2) inhibitors

o   Abstract #4348 / Session: Experimental and Molecular Therapeutics / Pharmacokinetics and Pharmacodynamics of Cancer Therapeutics

o   Tuesday, April 29, 9:00 AM – 12:00 PM (PT), Section 20, Poster #13, Convention Center

Translational pharmacokinetic/pharmacodynamic (PK/PD) modeling for VVD-130037, an innovative covalent small molecule Kelch-like ECH-associated protein 1 (KEAP1) activator

o   Abstract #4349 / Session: Experimental and Molecular Therapeutics / Pharmacokinetics and Pharmacodynamics of Cancer Therapeutics

o   Tuesday, April 29, 9:00 AM – 12:00 PM, Section 20, Poster #14, Convention Center

Discovery and characterization of BAY 3498264: a small molecule inhibitor targeting the RAS-SOS1 interaction

o   Abstract #4373 / Session: Experimental and Molecular Therapeutics / RAS Inhibitors

o   Tuesday, April 29, 9:00 AM – 12:00 PM (PT), Section 21, Poster #8, Convention Center

BAY 2927088: a novel treatment option for patients with NSCLC with HER2 mutations

o   Abstract #5610 / Session: Experimental and Molecular Therapeutics / Kinase and Phosphatase Inhibitors 3

o   Tuesday, April 29, 2:00 PM – 5:00 PM (PT), Section 20, Poster #20, Convention Center