Aravive and 3D Medicines Announce Strategic Collaboration to Develop and Commercialize AVB-500 in Greater China

Rhea-AI Summary

Aravive has entered into a collaboration with 3D Medicines to develop and commercialize AVB-500 for oncology in Greater China. The deal includes a $12 million signing payment, potential milestone payments of up to $207 million, and tiered royalties on net sales. AVB-500 targets the GAS6-AXL pathway, previously showing positive Phase 1b trial results in platinum-resistant ovarian cancer. Under the agreement, 3D Medicines will cover all development costs while Aravive retains rights outside Greater China, continuing its development activities elsewhere.

Positive

• Aravive to receive a $12 million signing payment.
• Potential for up to $207 million in milestone payments and tiered royalties from 3D Medicines.
• Promising Phase 1b trial results for AVB-500 in platinum-resistant ovarian cancer.
• Collaboration expands AVB-500's geographic reach into Greater China.

Negative

• None.

Aravive to Receive $12 Million Signing Payment, up to an Additional $207 Million in Future Milestone Payments plus Tiered Royalties

3D Medicines to Lead Clinical Development and Commercialization of AVB-500 in Greater China

HOUSTON and SHANGHAI, China, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing transformative therapeutics, and 3D Medicines Inc., a China-based biopharmaceutical company developing next-generation immuno-oncology drugs, today announced 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).

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.

About 3D Medicines
3D Medicines, Inc. is a biopharmaceutical company at the stage of late clinical development and early commercialization. With the concept “Help people with cancer live longer and better,” aiming for the future long-term survival of tumor patients, 3D Medicines focuses on the development of differentiated next-generation immuno-oncology drugs, to help cancer patients live longer with better quality of life. 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. For more information, please visit www.3d-medicines.com.

About Aravive
Aravive, Inc. is a clinical-stage oncology company developing transformative therapeutics designed to halt the progression of life-threatening diseases. Aravive’s lead therapeutic, AVB-500, is an ultra-high affinity decoy protein that targets the GAS6-AXL signaling pathway associated with tumor cell growth. Aravive recently successfully completed a Phase 1b trial of AVB-500 in platinum resistant ovarian cancer and selected 15 mg/kg as the dose for the pivotal trial. While the Phase 1b trial of AVB-500 in platinum resistant ovarian cancer was a safety trial and not powered to demonstrate efficacy, all 5 patients in the 15 mg/kg cohort experienced clinical benefit, with 1 complete response, 2 partial responses, and 2 stable disease. The Company also intends to initiate a Phase 1b/Phase 2 trial of AVB-500 in clear cell renal cell carcinoma later this year. For more information, please visit www.aravive.com.

Forward-Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended), express or implied, such statements regarding 3D Medicines being an excellent partner for the development and potential commercialization of AVB-500 in China, potentially bringing AVB-500 to patients in China, with the goal of improving the cancer treatment landscape across various tumor types, the Company receiving up to $207 million in development and commercial milestone payments under the terms of the agreement, AVB-500, used in combination with existing standard of care therapeutics, being able to alter the treatment paradigm across various tumor types, and the Company initiating a Phase 1b/Phase 2 trial of AVB-500 in clear cell renal cell carcinoma later this year. Forward-looking statements are based on current beliefs and assumptions, are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those contained in any forward-looking statement as a result of various factors, including, but not limited to, risks and uncertainties related to: whether the collaboration will be successful and result in any development and commercial milestone payments or royalty payments under the terms of the agreement, the ability to bring AVB-500 to patients in China and improve the cancer treatment landscape across various tumor types, , our ability to establish that AVB-500, used in combination with existing standard of care therapeutics, is able to alter the treatment paradigm across various tumor types, our ability to initiate a Phase 1b/Phase 2 trial of AVB-500 in clear cell renal cell carcinoma as scheduled later this year, the impact of COVID-19 on the Company's clinical strategy, clinical trials, supply chain and fundraising, the Company's ability to expand development into additional oncology indications, the Company's dependence upon AVB-500, AVB-500's ability to have favorable results in clinical trials and ISTs, the clinical trials of AVB-500 having results that are as favorable as those of preclinical and clinical trials, the ability to receive regulatory approval, potential delays in the Company's clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients especially in light of the COVID-19 pandemic; the risk that AVB-500 may cause serious side effects or have properties that delay or prevent regulatory approval or limit its commercial potential; the risk that the Company may encounter difficulties in manufacturing AVB-500; if AVB-500 is approved, risks associated with its market acceptance, including pricing and reimbursement; potential difficulties enforcing the Company's intellectual property rights; the Company's reliance on its licensor of intellectual property and financing needs. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, recent Current Reports on Form 8-K and subsequent filings with the SEC. Except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:
Media:
Sheryl Seapy, W2O
sseapy@w2ogroup.com
(213) 262-9390

Investors:
Luke Heagle, W2O
lheagle@w2ogroup.com
(910) 726-1372

FAQ

What is Aravive's collaboration with 3D Medicines about?

Aravive has partnered with 3D Medicines to develop and commercialize AVB-500 across oncology indications in Greater China.

How much will Aravive receive from the collaboration with 3D Medicines?

Aravive will receive a $12 million signing payment and could earn up to $207 million in milestone payments.

What is AVB-500 designed to target?

AVB-500 targets the GAS6-AXL signaling pathway, which is associated with tumor cell growth.

What are the results of AVB-500's clinical trials?

AVB-500 showed positive results in a Phase 1b trial for platinum-resistant ovarian cancer.

What rights does Aravive retain for AVB-500 after the collaboration?

Aravive retains all rights to AVB-500 outside of Greater China and will continue its development activities in other regions.