• Ph I trial showed reduction in biomarker associated with anti-tumor activity in animal models
• There were no serious or dose-limiting adverse events in the Ph I trial
• Aravive has a manufacturing collaboration with WuXi for AVB-S6-500

Aravive Biologics, Inc. announced on 8/20/18 that the U.S. Food and Drug Administration has granted Fast Track Designation to AVB-S6-500 as a potential treatment for platinum-resistant recurrent ovarian cancer.

“We are very pleased that the FDA has granted Fast Track status to AVB-S6-500,” said Gail McIntyre Ph.D., DABT, Senior Vice President of R&D 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.”

AVB-S6-500 is a novel high-affinity, soluble Fc-fusion protein designed to block the activation of the GAS6-AXL signaling pathway by intercepting the binding of GAS6 to its receptor AXL. Research has shown GAS6-AXL signaling to be a key molecular pathway that promotes tumor growth and metastases, as well as immune evasion and resistance to other anticancer agents. AXL and GAS6 expression correlate with poor prognosis in cancer. Results of a Phase 1 study of AVB-S6-500 in healthy volunteers showed a favorable safety profile, with no reported serious or dose-limiting adverse events. Moreover, results of that trial showed a dose-related reduction of circulating free GAS6, a measurement that Aravive anticipates will be highly useful as a biomarker to better monitor the therapeutic responses and potentially to better select responder patient populations. A reduction in this biomarker has correlated to anti-tumor activity in preclinical animal studies. In preclinical studies, GAS6-AXL inhibition has shown activity, whether achieved by a single agent (including AVB-S6-500) or through combinations of a variety of anticancer therapies including radiation therapy, immuno-oncology agents, and drugs that affect DNA replication and repair. GAS6/AXL inhibition has also shown potential as a strategy for the treatment of certain fibrotic diseases.

In January of 2018, Aravive announced a manufacturing collaboration with WuXi Biologics. With WuXi's help Aravive was able to scale up from plasmid to IND for AVB-S6-500 in less than 16 months.