This programme is designed to expedite the development and review of new therapies targeting serious or life-threatening conditions by demonstrating the potential to address unmet medical needs.
A Phase I/II clinical trial of VLS-1488 is currently underway in patients with advanced tumours, including HGSOC.
This first-in-human study is composed of two parts: dose escalation and dose expansion, aimed at determining the Maximum Tolerated Dose (MTD) and selecting dose levels for further study.
It will also assess the safety, tolerability, and preliminary efficacy of the VLS-1488 single agent.
During the dose escalation phase, the therapy’s safety and tolerability are being assessed across various solid tumour types and dose levels.
A Bayesian Optimal Interval (BOIN) design is being utilised to guide dose (de-)escalation and identify the MTD.
The subsequent dose expansion phase will further examine the safety, tolerability, drug-drug interaction (DDI) risk, food effect (FE), and initial efficacy at different tumour types and/or dose levels of interest.
Administered orally in 28-day cycles, VLS-1488 can be continued until disease progression, unacceptable toxicity, withdrawal of consent, or other stopping criteria are met.
Volastra Therapeutics Research and Development head and chief medical officer Scott Drutman said: “Platinum-resistant high-grade serous ovarian cancer is marked by poor prognosis, highlighting the urgent need for new therapies for this devastating disease.
“Fast track designation for VLS-1488 reaffirms the clear potential of KIF18A inhibition to address this unmet medical need and represents a critical step towards bringing these novel therapeutics to patients. We look forward to working closely with the FDA as we advance the development of inhibitors against this promising target.”