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US FDA Grants Fast Track Designation to Aravive Biologics' AVB-S6-500.

M2 PHARMA-August 22, 2018-US FDA Grants Fast Track Designation to Aravive Biologics' AVB-S6-500

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- The US Food and Drug Administration has granted Fast Track Designation to AVB-S6-500 as a potential treatment for platinum-resistant recurrent ovarian cancer, US-based Aravive Biologics, Inc said.

FDA Fast Track Designation is intended to facilitate development and expedite review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.

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.

Aravive Biologics is a clinical stage pharmaceutical company focused on developing novel, highly selective therapies designed to treat serious cancers and certain fibrotic diseases.

The company's primary therapeutic focus is the GAS6-AXL pathway, where AXL receptor signaling plays a critical role in multiple types of malignancies by promoting metastasis and cancer cell survival.

Aravive Biologics has generated strong preclinical data for its lead drug candidate AVB-S6-500 in a variety of cancer models and recently completed a Phase 1 clinical study that established proof of mechanism at all doses tested in human subjects and suppressed serum GAS6 for at least one week.

The company is based in Houston, Texas, and receives support from the Cancer Prevention and Research Institute of Texas (CPRIT).

On June 3, 2018, Aravive entered into an Agreement and Plan of Merger and Reorganization with Versartis, Inc., and its wholly owned subsidiary Velo Merger Sub, Inc.

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Publication:M2 Pharma
Date:Aug 22, 2018
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