Aravive Biologics ovarian cancer drug AVB-S6-500 gets FDA fast track designation

August 20, 2018 | Filed under: Pharma Regulatory News | Posted by: pharmanewsdaily Tags: Aravive Biologics, AVB-S6-500, Gail McIntyre, Oncology, Ray Tabibiazar, US FDA, USA

Aravive Biologics has secured fast track designation from the US Food and Drug Administration (FDA) for its ovarian cancer drug AVB-S6-500 for the treatment of platinum-resistant recurrent ovarian cancer.

A high-affinity, soluble Fc-fusion protein, AVB-S6-500 has been designed to prevent the activation of the GAS6-AXL signaling pathway. The drug functions by intercepting the binding of GAS6 to its receptor AXL.

GAS6-AXL signaling has been shown in research to be a key molecular pathway that fosters tumor growth and metastases, and also immune evasion and resistance to other anticancer agents.

Commenting on FDA fast track designation for AVB-S6-500, Ray Tabibiazar – Executive Chairman of Aravive Biologics, said: “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.

“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.”

US FDA grants fast track designation to Aravive Biologics ovarian cancer drug AVB-S6-500. Photo courtesy of Stuart Miles/Freedigitalphotos.net.

Through its fast track designation, the ovarian cancer drug AVB-S6-500 gets the opportunity to be available to the patient earlier than otherwise should it meet its clinical goals.

Gail McIntyre – Senior Vice President of R&D at Aravive, commenting on FDA fast track designation for AVB-S6-500, said: “We are very pleased that the FDA has granted Fast Track status to AVB-S6-500.

“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.”

In a phase 1 study in healthy volunteers, AVB-S6-500 demonstrated a favorable safety profile, with no serious or dose-limiting adverse events recorded.

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