Aravive Biologics’ Therapy Earns FDA’s Fast Track Designation to Treat Advanced Ovarian Cancer

Aravive Biologics’ Therapy Earns FDA’s Fast Track Designation to Treat Advanced Ovarian Cancer

The U.S. Food and Drug Administration (FDA) has granted fast track designation to AVB-S6-500 as a potential therapy for chemotherapy-resistant ovarian cancer, Aravive Biologics, the therapy’s developer, announced.

Fast track designation is given to investigational therapeutics for serious conditions in which the available treatments still fall short. The aim is to expedite such therapies’ clinical development.

“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 a press 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,” Tabibiazar said..

AVB-S6-500 binds to a protein called growth arrest-specific factor 6 (Gas6) and works as a decoy that significantly reduces or prevents GAS6’s ability to bind and stimulate the AXL receptor pathway.

Elevated GAS6 levels have been associated with more aggressive staging of cancers, poorer predicted patient survival, acquired drug resistance, and metastasis in patients with advanced ovarian and breast cancer, and in patients with acute myeloid leukemia (AML).

AVB-S6-500 neutralizes GAS6 and effectively turns off AXL signaling in tumor cells. In preclinical models of AML and other advanced solid tumors, inhibition of the AXL-GAS6 interaction stopped the tumor’s progression.

In solid tumors, AVB-S6-500 has additional anti-cancer benefits with the therapy also stimulating innate immune responses against the tumor.

In a recently completed Phase 1 clinical trial (NCT03401528) with 43 healthy volunteers, single-ascending and repeat doses of AVB-S6-500 were safe and well-tolerated.

Moreover, data from the single-ascending doses showed a dose-dependent decrease in the measurable circulating free GAS6 in participants’ blood samples, confirming the therapy’s high affinity for GAS6. In fact, the affinity of AVB-S6-500 to GAS6 was 100 times higher than that of GAS6 to its natural AXL receptor, according to Aravive.

“We are very pleased that the FDA has granted Fast Track status to AVB-S6-500,” said Gail McIntyre PhD, senior vice president of research and development at Aravive.

“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,” she added. ​