On November 10, 2020 Aravive Inc., a clinical-stage oncology company developing transformative therapeutics, and 3D Medicines Inc., a China-based biopharmaceutical company developing next-generation immuno-oncology drugs, reported a collaboration and exclusive license agreement for the development and commercialization of AVB-500 across all oncology indications in mainland China, Hong Kong, Macau, and Taiwan (Greater China) (Press release, 3D Medicines, NOV 10, 2020, View Source [SID1234594023]).

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AVB-500 is an ultra-high affinity decoy protein that targets the GAS6-AXL signaling pathway associated with tumor cell growth. Aravive successfully completed a Phase 1b trial of AVB-500 in platinum resistant ovarian cancer and is also evaluating AVB-500 in clear cell renal cell carcinoma.

"We believe 3D Medicines is an excellent partner for the development and potential commercialization of AVB-500 in China," said Gail McIntyre, Ph.D., Chief Executive Officer of Aravive. "3D Medicines has built a pipeline with both innovative biological and small-molecule anti-tumor drugs and a professional team with global development, registration and commercialization capabilities. Following promising results from our Phase 1b trial of AVB-500 in platinum resistant ovarian cancer, we are excited to partner with 3D Medicines to potentially bring AVB-500 to patients in China, expanding AVB-500 clinical indications and broadening our geographic reach."

Under the terms of the agreement, Aravive will receive a signing payment of $12 million and be eligible to receive up to $207 million in development and commercial milestone payments with the potential for near term milestone payments of $6 million. In addition, 3D Medicines will pay Aravive tiered royalties ranging from the low double digits to mid-teens as a percentage of annual net sales of AVB-500 in Greater China. 3D Medicines will be responsible for all costs associated with development and commercialization activities for AVB-500 in Greater China. Aravive will retain all rights to AVB-500 in the rest of the world and will continue to be responsible for the development and commercialization of AVB-500 in the United States and other geographies.

"We are very pleased to enter into this exclusive collaboration with Aravive," said John Gong, M.D., Ph.D., Chairman and Chief Executive Officer of 3D Medicines. "We believe that AVB-500, used in combination with existing standard of care therapeutics or Envafolimab, an innovative subcutaneous PD-L1 antibody to be launched in China soon, could alter the treatment paradigm across various tumor types. We are committed to working closely with Aravive to further advance the development of AVB-500 and bring this important potential therapy to patients living with cancer in China."

BFC Group, Ltd. acted as advisors to Aravive, Inc.

About AVB-500
AVB-500 is a therapeutic recombinant fusion protein that has been shown to neutralize GAS6 activity by binding to GAS6 with very high affinity in preclinical models. In doing so, AVB-500 selectively inhibits the GAS6-AXL signaling pathway, which is upregulated in multiple cancer types including ovarian cancer. In preclinical studies, GAS6-AXL inhibition has shown anti-tumor activity in combination with a variety of anticancer therapies, including radiation therapy, immuno-oncology agents, and chemotherapeutic drugs that affect DNA replication and repair. Increased expression of AXL and GAS6 in tumors has been correlated with poor prognosis and decreased survival and has been implicated in therapeutic resistance to conventional chemotherapeutics and targeted therapies. AVB-500 is currently being evaluated in clinical trials and has been granted Fast Track Designation by the U.S. Food and Drug Administration in platinum resistant recurrent ovarian cancer. Analysis of all safety data to date showed that AVB-500 has been generally well-tolerated with no dose-limiting toxicities or unexpected safety signals.