Volastra Highlights Early Data for KIF18A Inhibitor at ASCO 2025

Volastra Therapeutics has shared encouraging initial findings from its Phase I/II study of VLS-1488, an oral KIF18A inhibitor, at the 2025 ASCO Annual Meeting. The trial (NCT05902988), which evaluates safety and tolerability, reported tumour shrinkage in seven of 17 response-evaluable patients with advanced high-grade serous ovarian cancer (HGSOC), including three partial responses as defined by RECIST criteria. Most participants had platinum-resistant disease, and five remain on treatment. Among the 52 patients treated in the dose-escalation phase, no dose-limiting toxicities occurred, and a maximum tolerated dose was not identified. Fewer than 45% experienced treatment-related side effects of any grade, with Grade 3 events reported in under 16%, and none beyond that severity. Patient enrolment continues in the dose-expansion phase, with study completion expected in June 2026. Volastra is also progressing sovilnesib, a second KIF18A inhibitor acquired from Amgen, while Accent Therapeutics is advancing ATX-295 in a similar early-phase trial.

02-06-2025