Volastra Therapeutics Announces First Patient Dosed in Phase Ib Clinical Trial of Sovilnesib

Volastra Therapeutics, a clinical-stage biotechnology company, today announced it has dosed the first patient in its Phase Ib clinical trial evaluating sovilnesib in patients with platinum-resistant or refractory high-grade serous ovarian cancer (HGSOC). This trial (NCT06084416) is a randomized dose optimization study of once-daily oral sovilnesib at different dose levels to establish the recommended Phase 2 dose.

Sovilnesib was granted Fast Track designation in this indication by the U.S. Food and Drug Administration (FDA) based on its initial clinical data as well as the high unmet need in this population. Volastra in-licensed sovilnesib (formerly AMG-650) from Amgen in February 2023. The company is also progressing its internally developed KIF18A inhibitor, VLS-1488, in an ongoing Phase 1 clinical trial (NCT05902988).

"Advancing our two chemically differentiated KIF18A inhibitors in parallel Phase 1 clinical trials presents the rare opportunity to efficiently gather comparative clinical data," said Charles Hugh-Jones, M.D., FRCP, Chief Executive Officer at Volastra. "We believe our strategy will allow us to select the first, and potentially best-in-class, medicine for patients to advance to late-stage development for treatment of platinum-resistant or refractory HGSOC."

In the U.S. alone, there are more than 20,000 new cases of ovarian cancer each year, over 75% of which are advanced. The majority of these patients will see disease progression on platinum-based therapy.

"Patients with advanced HGSOC have poor treatment response rates after disease progression on platinum-based chemotherapy, and as a result have a significant need for new treatment options," Dr. Joyce Liu M.D., MPH, Associate Chief and Director of Clinical Research in the Division of Gynecologic Oncology at Dana Farber Cancer Institute and a principal investigator on the trial, commented. "We are excited to participate in this trial evaluating a unique treatment approach in hopes of advancing new options for patients."

In addition to clinical development of novel therapeutics, Volastra is deploying multiple unique biomarker approaches to measure chromosomal instability and other predictors of response to KIF18A inhibitors through partnerships with companies including Microsoft, Tailor Bio, and Function Oncology.

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, Droia Ventures, Vida Ventures, Catalio Capital Management, and Eli Lilly & Company. 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, progresses internally and in collaboration with Bristol Myers Squibb.

For more information, please visit www.volastratx.com.