On October 10, 2022 Aravive Inc. (Nasdaq: ARAV), a late clinical-stage oncology company developing innovative therapeutics to treat life-threatening diseases, reported that it received a $6 million development milestone payment from its licensee, 3D Medicines Inc (Press release, Aravive, OCT 10, 2022, View Source [SID1234621854]). This milestone is based on the initiation of the global Phase 3 platinum resistant ovarian cancer (PROC) clinical trial in China for the development of Aravive’s batiraxcept.
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Gail McIntyre, Ph.D., DABT, Chief Executive Officer, said, "Our partnership with 3D Medicines continues with positive progress as they move forward with enrollment in the Phase 3 Trial for batiraxcept (3D-299) in China. Their enrollment of patients will support Aravive’s potential marketing application for batiraxcept in the United States, as well as their potential marketing application in China. This is our third milestone achieved since entering our agreement with 3D Medicines in November 2020 and we look forward to continued advancement towards the potential approval of batiraxcept in both the United States and China. Our companies are dedicated and working together to improve patient survival and bring hope to women with advanced ovarian cancer."
Aravive’s collaboration and license agreement with 3D Medicines Inc. is for the development and commercialization of batiraxcept in oncology indications in Greater China. Under the terms of the agreement, Aravive is eligible to receive up to an aggregate of $207 million in development and commercial milestone payments and royalties. In addition to achieving this $6 million development milestone, the Company had previously received a $9 million in development milestones related to development of batiraxcept for platinum resistant ovarian cancer in the United States and China, as well as a $12 million upfront payment in 2020, totaling $27 million that has been achieved by Aravive from 3D Medicines.
About the Phase 3 PROC Trial
The global, randomized, double-blind, placebo-controlled trial (GOG-3059/ENGOT OV-66) is designed to evaluate efficacy and safety of batiraxcept at a dose of 15 mg/kg in combination with paclitaxel. The trial is expected to enroll approximately 300-400 patients with high-grade serous ovarian cancer who have received one to four prior lines of therapy at approximately 150 sites in North America, Europe, and Asia. The primary endpoint for the trial is progression free-survival and the secondary endpoint is overall survival. Exploratory endpoints include objective response rate, duration of response, quality of life, clinical benefit rate, pharmacokinetic and pharmacodynamic profile, and sAXL/GAS6 ratio. This trial is being conducted in partnership with The GOG Foundation, Inc. (GOG-F), through the GOG Partners program in the USA, and in partnership with the European Network for Gynaecological Oncological Trial (ENGOT) groups in Europe. The Phase 3 trial is listed on clinicaltrials.gov NCT04729608.