Volastra Therapeutics has announced the preliminary data of its oral kinesin family member 18A (KIF18A) inhibitor, VLS-1488, showing tumour shrinkage and a tolerable safety profile.
The ongoing Phase I/II trial (NCT05902988) is focused on the safety and tolerability of VLS-1488. However, the study found that at the time of data cutoff, seven of the 17 response-evaluable advanced high-grade serous ovarian cancer (HGSOC) patients, most of whom were platinum-resistant, saw tumour shrinkage, including three partial responses per Response Evaluation Criteria in Solid Tumours (RECIST), with five patients remaining on therapy.
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In all 52 advanced solid tumour patients enrolled on the dose-escalation portion of the study, there were no dose-limiting toxicities observed, and a maximum tolerated dose was not reached at the 10 January data cutoff.
Less than 45% of patients experienced treatment-related adverse events (TRAEs) of any grade and less than 16% of all patients experienced Grade 3 TRAEs. No patients experienced TRAEs higher than Grade 3.
Volastra is continuing to enrol patients in the dose expansion portion of the Phase I/II study, with an expected completion in June 2026.
Dr Ecaterina Dumbrava, assistant professor of investigational cancer therapeutics at The University of Texas MD Anderson Cancer Center and trial investigator, said: “These early data show VLS-1488 to be very well tolerated, with promising initial efficacy in ovarian cancer. The data that will be presented demonstrates the potential of KIF18A as a novel, relevant therapeutic target for hard-to-treat cancers, and I look forward to continued development.”
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By GlobalDataThe data will be featured in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on 2 June. ASCO is taking place from 30 May to 3 June 2025 in Chicago, Illinois.
Volastra has another KIF18A inhibitor in its pipeline, sovilnesib, which was acquired through a deal with Amgen in 2023. The drug is in an ongoing Phase Ib trial (NCT06084416) in ovarian cancer and is estimated to enrol 120 patients. The trial is due to complete in June 2025.
US-based biopharma Accent Therapeutics is also running a Phase I/II trial of its own KIF18A inhibitor ATX-295. The trial is enrolling patients with locally advanced or metastatic solid tumours, including HGSOC.
