FDA News

FDA grants fast track designation to AVB-S6-500 for ovarian cancer

The FDA granted AVB-S6-500 — an inhibitor of the GAS6-AXL signaling pathway — fast track designation for the treatment of women with platinum-resistant recurrent ovarian cancer, according to the agent’s manufacturer.

AVB-S6-500 (Aravive Biologics) is a novel high-affinity, soluble Fc-fusion protein designed to intercept the binding of GAS6 to its receptor AXL. AXL and GAS6 expression correlate with poor prognosis in cancer.

“This important designation is based on the promising safety and activity observed to date with AVB-S6-500, and we look forward to working closely with the FDA as we advance its development in ovarian cancer,” Gail McIntyre PhD, DABT, senior vice president of research and development at Aravive Biologics, said in a company-issued press release.

The FDA based the fast track designation on results of a phase 1 study of healthy volunteers.

Results showed a dose-related reduction in circulating free GAS6. Researchers observed a favorable safety profile, with no reported serious or dose-limiting adverse events.

“Gaining fast track designation is an important recognition of the potential that AVB-S6-500 has to offer to meet a critical unmet medical need for patients with recurrent ovarian cancer,” Ray Tabibiazar, MD, executive chairman of Aravive Biologics, said in the release. “We look forward to initiating the phase 1b portion of our planned phase 1b/2 study combining AVB-S6-500 with standard-of care therapies in patients with platinum-resistant ovarian cancer before the end of the year.”

The FDA granted AVB-S6-500 — an inhibitor of the GAS6-AXL signaling pathway — fast track designation for the treatment of women with platinum-resistant recurrent ovarian cancer, according to the agent’s manufacturer.

AVB-S6-500 (Aravive Biologics) is a novel high-affinity, soluble Fc-fusion protein designed to intercept the binding of GAS6 to its receptor AXL. AXL and GAS6 expression correlate with poor prognosis in cancer.

“This important designation is based on the promising safety and activity observed to date with AVB-S6-500, and we look forward to working closely with the FDA as we advance its development in ovarian cancer,” Gail McIntyre PhD, DABT, senior vice president of research and development at Aravive Biologics, said in a company-issued press release.

The FDA based the fast track designation on results of a phase 1 study of healthy volunteers.

Results showed a dose-related reduction in circulating free GAS6. Researchers observed a favorable safety profile, with no reported serious or dose-limiting adverse events.

“Gaining fast track designation is an important recognition of the potential that AVB-S6-500 has to offer to meet a critical unmet medical need for patients with recurrent ovarian cancer,” Ray Tabibiazar, MD, executive chairman of Aravive Biologics, said in the release. “We look forward to initiating the phase 1b portion of our planned phase 1b/2 study combining AVB-S6-500 with standard-of care therapies in patients with platinum-resistant ovarian cancer before the end of the year.”