- First patient dosed in global Phase 2 study evaluating VVD-214, an oral Werner helicase (WRN) inhibitor, plus pembrolizumab in front-line patients with advanced MSI-high or dMMR colorectal cancer
- Study broadens clinical development of VVD-214 into the first-line setting, complementing ongoing Phase 1b study in patients whose disease has progressed following prior therapy
- Colorectal cancer remains an area of significant unmet medical need, and approximately 15 percent of tumors are MSI-high, representing the largest population of patients with MSI-high disease1
Vividion Therapeutics, Inc. (Vividion), a clinical-stage biopharmaceutical company and a wholly owned and independently operated subsidiary of Bayer AG, today announced that the first patient has been dosed in a Phase 2 clinical trial of VVD-214, an investigational oral inhibitor of Werner helicase (WRN). The randomized study will evaluate VVD-214 in combination with pembrolizumab versus pembrolizumab alone as first-line treatment for patients with advanced microsatellite instability-high (MSI-high) or deficient mismatch repair (dMMR) colorectal cancer. Colorectal cancer remains an area of significant medical need, and approximately 15 percent of tumors are MSI-high, representing the largest population of patients with MSI-high disease.
The Phase 2 trial expands clinical development of VVD-214 to investigate its potential applicability in earlier treatment lines for advanced colorectal cancer.Vividion's recently initiated Phase 1b clinical trial (NCT06004245) is additionally evaluating VVD-214 in combination with bevacizumab in patients with MSI-high or dMMR colorectal cancer whose disease has progressed following prior lines of therapy.
"The progress of VVD-214 has strengthened our conviction in WRN inhibition and created an opportunity to broaden the program in front-line colorectal cancer, where effective and better tolerated treatment options are needed," said Aleksandra Rizo, M.D., Ph.D., President and Chief Executive Officer of Vividion. "Supported by encouraging early clinical data and strong investigator interest, we are moving rapidly into Phase 2 to evaluate VVD-214 in the first-line setting and explore its potential to improve outcomes for more patients."
VVD-214 is an investigational oral small-molecule inhibitor of WRN, a DNA repair enzyme and synthetic lethal target for MSI-high or dMMR cancers. By inhibiting WRN, VVD-214 is designed to selectively induce lethal DNA damage in cancer cells while minimizing harm to normal cells. Preliminary data from the Phase 1a study presented at the American Association for Cancer Research (AACR) 2025 Annual Meeting and published in Nature Medicineshowed that VVD-214 was well tolerated with early signals of activity.2
"The encouraging clinical evidence generated to date gives us confidence to broaden the program into the first-line setting and evaluate VVD-214 as a meaningful new treatment option for patients with MSI-high or dMMR colorectal cancer," said Christian Rommel, Ph.D., Global Head of Research and Development at Bayer's Pharmaceuticals Division.
The global Phase 2 trial of VVD-214 (NCT07811193) is planned to enroll approximately 140 patients at clinical sites across approximately 21 countries in North America, Latin America, Europe and Asia. The primary endpoint is six-month progression-free survival rate, with secondary endpoints including objective response rate, disease control rate, duration of response, overall survival and safety.
Vividion also has ongoing Phase 1 trials evaluating an oral KEAP1 activator in advanced solid tumors and a RAS-PI3Ka inhibitor designed to target RAS-driven cancers. The company is advancing multiple innovative drug discovery programs toward the clinic, with a growing early discovery pipeline, emerging from its chemoproteomics platform, that spans oncology and immunology.
About Vividion
Vividion Therapeutics, Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a clinical-stage biopharmaceutical company utilizing novel discovery technologies to unlock difficult-to-drug targets with strong disease-links, and to develop small molecule precision therapeutics for devastating cancers and immune disorders. The company's platform has enabled it to identify hundreds of previously unknown functional pockets on well-validated protein targets implicated in a wide range of diseases, while simultaneously identifying compounds from its proprietary covalent chemistry library that interact in a highly selective manner with those pockets. The company is leveraging its proprietary chemoproteomic platform to advance a diversified pipeline of highly selective small molecule therapeutics targeting high-value, traditionally undruggable targets in oncology and immunology. For more information, please visit www.vividion.com.
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 support efforts to master major challenges presented by a growing and aging global population and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.
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1 Vilar E, Gruber SB. Microsatellite instability in colorectal cancer-the stable evidence. Nat Rev Clin Oncol. 2010;7(3):153-62. doi:10.1038/nrclinonc.2009.237 |
2 Yap TA, Fontana E, Cook N, et al. Werner helicase inhibitor for advanced microsatellite instability solid tumors: a phase 1 trial. Nat Med. Published online September 29, 2026. doi:10.1038/s41591-026-04657-3 |
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Contacts:
Vividion Media Contact:
Rhiannon Benilov, phone +1 978 417 1946
Email: rhiannon@tenbridgecommunications.com
Bayer Global Media Contact:
Julia Schulze, phone +49 175 586 6432
Email:julia.schulze@bayer.com
