Aravive Biologics Initiates Phase 1b Portion of Phase 1b/2 Clinical Trial

Aravive, Inc. recently announced the company has begun treating patients in the Phase 1b portion of a Phase 1b/Phase 2 trial combining AVB-S6-500 with standard-of-care therapies in patients with platinum-resistant recurrent ovarian cancer.

“We are very pleased to initiate this first trial of AVB-S6-500 in patients with ovarian cancer,” said Gail McIntyre PhD, DABT, Senior Vice President of R&D at Aravive. “Our initial Phase 1 clinical trial of this agent in healthy volunteers showed a favorable safety and tolerability profile, with no reported serious adverse events and no adverse events that limited dosing in the trial. We also suppressed circulating free GAS6 across all dose levels and higher doses suppressed circulating free GAS6 for a longer duration than lower doses. We anticipate the measurement of circulating free GAS6 will be highly useful as a biomarker of drug activity in this new trial. A reduction in this biomarker has correlated to anti-tumor activity in preclinical studies.”

“We are excited to have begun enrollment in this clinical trial of platinum-resistant ovarian cancer,” added study investigator Bradley Monk, MD, FACOG, FACS, Professor, University of Arizona College of Medicine and Medical Director, US Oncology Research Network – Gynecologic Program. “There are limited therapeutic options for platinum-resistant patients and the GAS6/AXL pathway is known to drive progression and resistance to treatments in ovarian cancer. Agents with a favorable safety profile like AVB-S6-500 offer a great opportunity for improving outcomes for our patients.”

The open label Phase 1b safety lead-in portion of the trial will enroll patients with platinum-resistant recurrent ovarian cancer and aims to confirm the dose based on results from the healthy volunteer clinical trial of AVB-S6-500. The primary endpoint for the Phase 1b portion of the clinical trial is safety, and pharmacokinetic/pharmacodynamic measurements with secondary endpoints including preliminary activity measures. The clinical trial will also explore AVB-S6-500 effects on biomarkers (GAS6-AXL) in serum and tumor tissues.

Elevated GAS6 levels have been associated with poor prognosis in cancer. As a decoy molecule, AVB-S6-500 has been shown to neutralize GAS6 activity by binding to that molecule with very high affinity. In doing so, AVB-S6-500 selectively inhibits triggering of the GAS6-AXL signaling pathway. 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 chemotherapeutic drugs that affect DNA replication and repair.

 Aravive, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies that target important survival pathways for cancer. Aravive’s lead candidate, 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. AXL receptor signaling plays an important role in multiple types of malignancies by promoting metastasis, cancer cell survival, resistance to treatments, and immune suppression. Aravive has initiated the Phase 1b portion of a Phase 1b/2 clinical trial of AVB-S6-500 combined with standard-of-care therapies in patients with platinum-resistant recurrent ovarian cancer, and intends to expand development into additional tumor types. For more information, visit www.aravive.com.