On September 29, 2026 Vividion Therapeutics, Inc. (Vividion), a clinical-stage biopharmaceutical company and a wholly owned and independently operated subsidiary of Bayer AG, reported the publication of the first peer-reviewed clinical data from the Phase 1 study of VVD-214, its investigational oral inhibitor of Werner helicase (WRN), in Nature Medicine. The findings demonstrated encouraging antitumor activity, including sustained disease control in patients with high microsatellite instability (MSI-high) colorectal cancer, and a manageable safety profile, supporting the ongoing Phase 1b and Phase 2 combination studies with VVD-214.

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VVD-214, referred to as RO7589831 (VVD-133214) in the publication, is an investigational oral therapy and the first covalent WRN inhibitor in clinical development. It is designed to exploit MSI-high cancer cells’ dependence on WRN-mediated DNA repair, causing lethal DNA damage in cancer cells while minimizing harm to normal cells.

The article, "Werner helicase inhibitor for advanced microsatellite instability solid tumors: a Phase 1 trial" (Yap et al., Nature Medicine,September 2026), reports results from 88 previously treated patients with advanced MSI-high and/or deficient mismatch repair (dMMR) solid tumors. The paper’s lead author is Timothy Yap, M.B.B.S., Ph.D., clinical investigator and professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center. The publication expands on initial findings Dr. Yap presented at the 2025 AACR (Free AACR Whitepaper) Annual Meeting.

A total of 66 patients who had a median of three prior lines of therapy, including 95.5% who received prior immune checkpoint therapy and had MSI-high tumors were evaluable for efficacy. VVD-214 demonstrated a disease control rate of 74.2%, including seven confirmed partial responses (10.6%). Median progression-free survival was 6.7 months, and median overall survival was 17.6 months. Among the subset of those patients with colorectal cancer (CRC), the disease control rate was 80.5%, including three confirmed partial responses (7.3%), and median progression-free survival was 7.3 months. Estimated overall survival at 12 months in this CRC population was 78.3%, with median overall survival not yet estimable. All three CRC responders remained in response at the data cutoff.

A total of 88 patients were evaluable for safety. Common treatment-emergent adverse events were mostly Grade 1 or 2, and treatment-emergent adverse events led to discontinuation in 3.4% of patients.

"These findings reinforce our conviction that synthetic lethal approaches can open new treatment possibilities for patients with MSI-high cancers," said Aleksandra Rizo, M.D., Ph.D., President and Chief Executive Officer of Vividion. "The encouraging colorectal cancer results strengthen the rationale for our ongoing combination studies as we work to extend the potential of VVD-214 across treatment settings."

Vividion is evaluating VVD-214 with bevacizumab in an ongoing Phase 1b study in patients with previously treated advanced MSI-high or dMMR colorectal cancer (NCT06004245). An ongoing Phase 2 study is evaluating VVD-214 with pembrolizumab in patients with previously untreated advanced MSI-high or dMMR colorectal cancer (NCT07811193). These studies are assessing whether complementary therapeutic approaches can build on the monotherapy activity observed in Phase 1.

(Press release, Vividion Therapeutics, SEP 29, 2026, View Source [SID1234671154])