The Food and Drug Administration (FDA) has granted Fast Track Designation to AVB-S6-500 (Aravive Biologics), an investigational treatment for platinum-resistant recurrent ovarian cancer.
AVB-S6-500 is a novel, high-affinity Fc-fusion protein designed to block the activation of the GAS6-AXL signaling pathway, which research has found to be key in promoting tumor growth and metastases. A Phase 1 study in healthy volunteers showed a favorable safety profile with no serious adverse events. In addition, a dose-related reduction in circulating free GAS6 was noted in the trial; a reduction in this biomarker has been associated with anti-tumor activity in preclinical studies.
‘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,” said Ray Tabibiazar, MD, Executive Chairman of Aravive Biologics.
For more information visit Aravive.com.