Aravive, Inc. announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the company's lead program, batiraxcept, for treatment of patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have progressed after 1 or 2 prior lines of systemic therapy that include both immuno-oncology -based and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI)-based therapies. Fast Track is a process designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fill an unmet medical need. Drugs that receive Fast Track designation may be eligible for more frequent communications and meetings with the FDA to discuss the drug's development plan, including the design of the proposed clinical trials, use of biomarkers and the extent of data needed to support approval.

Drugs with Fast Track Designation may also qualify for accelerated and priority review of new drug applications if relevant criteria are met. The Fast Track Designation was based on new data submitted to the agency from the P1b clear cell renal cell cancer study. As of September 26, 2022, 26 previously treated (second line or greater) patients with ccRCC have been treated with batiraxcept in the Phase 1b portion of a Phase 1b/2 trial at doses of 15 mg/kg (n=16) and 20 mg/kg, plus cabozantinib 60 mg daily.

There were no dose limiting toxicities observed at either dose. Clinical data from this study demonstrate that batiraxcept has the potential to increase the clinical activity of cabozantinib in patients with metastatic ccRCC who have progressed following IO- and VEGF-TKI-based therapies as the Objective Response Rate was 57% and median Progression-Free Survival was 11.4 months in this population.