Aravive announces Fast Track Designation of batiraxcept for treatment of ccRCC

Aravive 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-based therapies. The Fast Track Designation was based on new data submitted to the agency from the P1b clear cell renal cell cancer study. "A review of the literature suggests that the clinical activity of cabozantinib is lower in those patients who have progressed following a VEGF-TKI-based therapy compared to patients who have progressed on IO or IO/IO therapy. Since preclinical data published by Xiao in 20191 observed that batiraxcept may restore TKI sensitivity, it makes sense that the combination of batiraxcept and cabozantinib may exhibit its greatest impact in those patients who have failed prior VEGF-TKI therapies," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "Understanding the P1b ccRCC data has allowed us to identify the most appropriate patient population in which to evaluate batiraxcept in combination with cabozantinib and potentially the quickest path to approval in this population with an unmet medical need."