Aravive Biologics’ AVB-S6-500 receives FDA fast track designation for ovarian cancer

Aravive Biologics, a biopharmaceutical company, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its novel drug AVB-S6-500, aimed at treating platinum-resistant recurrent ovarian cancer. This significant regulatory milestone accelerates the drug’s development and potential commercialization, addressing an urgent need for new treatments in this challenging cancer subtype.

AVB-S6-500 is a high-affinity, soluble Fc-fusion protein designed to block the GAS6-AXL signaling pathway, a crucial molecular mechanism known to promote tumor growth, metastasis, immune evasion, and resistance to existing anticancer agents. By intercepting the binding of GAS6 to its receptor AXL, AVB-S6-500 aims to inhibit these processes and reduce tumor viability.

Ray Tabibiazar, Executive Chairman of Aravive Biologics, highlighted the importance of this advancement: “Gaining Fast Track Designation is an important recognition of the potential that AVB-S6-500 has to offer to meet a critical unmet medical need for patients with recurrent ovarian cancer. 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.”

The FDA’s Fast Track designation facilitates the development and expedited review of drugs that treat serious conditions and fill an unmet medical need, providing a pathway to earlier patient access should the drug meet its clinical goals. This designation is based on the promising safety and efficacy observed in initial trials, including a Phase 1 study in healthy volunteers where AVB-S6-500 demonstrated a favorable safety profile, with no serious or dose-limiting adverse events.

Gail McIntyre, Senior Vice President of R&D at Aravive, commented on the designation: “We are very pleased that the FDA has granted Fast Track status to AVB-S6-500. 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.”

The fast-track status not only underscores the therapeutic potential of AVB-S6-500 but also enhances Aravive Biologics’ capacity to provide an innovative treatment solution rapidly to patients suffering from platinum-resistant ovarian cancer—a condition often characterized by poor prognosis and limited treatment options.

As Aravive Biologics progresses with its clinical trials, the oncology community watches with anticipation, hoping for breakthrough therapies that can significantly alter the landscape of ovarian cancer treatment.