On October 30, 2023 Volastra Therapeutics, a discovery and clinical-stage cancer biotechnology company, reported the dosing of the first patient in a Phase I/II clinical trial evaluating VLS-1488 (Press release, Volastra Therapeutics, OCT 30, 2023, View Source [SID1234636451]). VLS-1488 and sovilnesib (formally AMG650) make up Volastra’s innovative clinical portfolio of differentiated KIF18A inhibitors specifically designed for the treatment of solid tumors characterized by high levels of chromosomal instability (CIN).
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The Phase I/II trial (NCT05902988) evaluates safety, tolerability and preliminary efficacy of VLS-1488 in patients with advanced tumors. The trial is a significant milestone in Volastra’s mission to help patients with these hard-to-treat cancers.
"In 2019, our team set out to understand the biology of chromosomal instability and discover new treatment approaches," said Charles Hugh-Jones M.D., FRCP, CEO at Volastra. "The ground-breaking work leading to this study has the potential to define the first-ever CIN-directed therapy."
KIF18A is a protein required by many tumor cells to divide and grow efficiently. It is not required by normal healthy cells to divide, allowing the selective killing of cancer cells. Volastra will deploy multiple exploratory biomarkers that measure CIN, including AI-based tissue imaging developed in partnership with Microsoft.
Dr. Pat LoRusso, D.O., Director of the Phase I Clinical Trial Unit at Yale commented, "Targeting chromosomal instability is a major opportunity for cancer therapy. Inhibiting KIF18A shows impressive data in pre-clinical models with high levels of CIN. We look forward to contributing to the clinical trial of this promising molecule."
Dr. Alexander Starodub, M.D., Ph.D., at The Christ Hospital Cancer Center in Cincinnati, Ohio dosed the first patient in this Phase 1 trial.