NEW YORK--(BUSINESS WIRE)--Volastra Therapeutics, a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VLS-1488, the company’s internally discovered KIF18A inhibitor. The designation has been granted for the treatment of patients with platinum-resistant high-grade serous ovarian cancer (HGSOC).
“Platinum-resistant high-grade serous ovarian cancer is marked by poor prognosis, highlighting the urgent need for new therapies for this devastating disease,” said Scott Drutman, M.D., Ph.D., Head of Research & Development and Chief Medical Officer. “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.”
Fast Track designation is a program intended to facilitate and expedite the development and review of new drugs for the treatment of a serious or life-threatening condition. To qualify for this designation, there must be clear data demonstrating the drug has potential to address unmet medical need in the designated condition.
In the U.S. alone, there are more than 20,000 new cases of ovarian cancer each year, over 75% of which are advanced. Most of these patients will see disease progression on platinum-based chemotherapy. Sovilnesib, the second of Volastra’s two KIF18A inhibitors, which was in-licensed from Amgen in 2023, has previously been granted Fast Track designation in this indication. Each of Volastra’s two KIF18A inhibitors, VLS-1488 and sovilnesib, has unique profiles and are both enrolling patients in early-phase studies.
The Phase I/II trial for VLS-1488 is evaluating safety, tolerability and preliminary efficacy in patients with advanced tumors, including HGSOC. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT05902988.
About Volastra Therapeutics, Inc.
Volastra Therapeutics is a New York-based clinical-stage biotechnology company pioneering novel approaches to treating cancer by targeting chromosomal instability. The company was founded in 2019 by Lewis Cantley, Ph.D., Samuel Bakhoum, M.D., Ph.D., and Olivier Elemento, Ph.D., and is funded by investors including Polaris Partners, Arch Ventures, Eli Lilly & Company, B Capital, Droia Ventures, Vida Ventures, and Catalio Capital Management. Volastra is developing new techniques to understand the biology of chromosomal instability and leveraging these insights to drive a pipeline of therapies towards innovative targets. The company leads the field with two differentiated clinical-stage KIF18A inhibitors, VLS-1488 and sovilnesib (formerly AMG-650). A robust discovery pipeline targeting novel approaches to chromosomal instability is progressing internally and in collaboration with Bristol Myers Squibb. Transformational partnerships with Microsoft, Tailor Biosciences, and Function Oncology support the identification of novel biomarkers to inform patient selection.
For more information, please visit www.volastratx.com.
