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3D Medicines Obtained Exclusive Authorization for the Development and Commercialization in Greater China for AVB-500, a New Anti-cancer Drug from Nasdaq-listed Aravive

2020-11-11 00:00:00 Source:思路迪 Author:思路迪医药 Views:813

Shanghai, November 11, 2020, and Houston, TX, United States, November 10, 2020 – 3D Medicines, Inc., a biopharmaceutical company focusing on the R&D and commercialization of innovative immuno-oncology drugs, and Aravive, Inc. (Nasdaq: ARAV), a new biopharmaceutical company, today announced an exclusive collaboration and license agreement for the development and commercialization of AVB-500 in mainland China, Hong Kong, Macau, and Taiwan (Greater China). After the introduction of RMX1001 and RMX1002, two innovative analgesics, from Haihe BioPharma, the collaboration was another important move for 3D Medicines in adapting to the trend of managing cancer as chronic illness, and keeping on building a pipeline that runs through the whole cycle of immuno-oncology.

 

AVB-500 is a high-affinity Fc fusion protein that targets GAS6, and also a new GAS6-AXL signaling pathway inhibitor. The GAS6-AXL signaling pathway is key to tumor cell growth and cancer metastasis, immune escape and drug tolerance, and GAS6-AXL has attracted wide attention as a new target for cancer treatment. GAS6 and its ligand, AXL are highly expressed and activated in malignant tumors including acute myeloid leukemia (AML), kidney cancer, pancreatic cancer, breast cancer, lung cancer, ovarian cancer and prostate cancer. GAS6-AXL signaling pathway inhibitor is an important breakthrough in cancer treatment today, as the combination of GAS6-AXL signaling pathway inhibitor with either immune checkpoint inhibitors, radiotherapy or chemotherapy can effectively control tumor cells. Having high clinical value and a promising market, GAS6-AXL signaling pathway inhibitor is hopefully an important drug to be combined with PD-L1.

 

By now, Aravive has successfully completed a Phase 1b trial of AVB-500 in platinum resistant ovarian cancer(PROC)in the United States, and the Phase 3 trial of AVB-500 is about to be initiated. Meanwhile, several other clinical trials have been initiated to evaluate the prospect of AVB-500 for the treatment of indications including clear cell renal cell carcinoma. After obtaining the exclusive authorization for the development and commercialization of AVB-500 in Greater China, 3D Medicines will initiate the clinical trials in China as soon as possible, so as to put the innovative drug to market sooner and benefit cancer patients around the globe.

 

Under the terms of the agreement, Aravive will receive an upfront payment of $12 million and be eligible to receive up to $207 million in development and commercial milestone payments. In addition, 3D Medicines will pay Aravive tiered royalties proportional to the annual net sales of AVB-500 in Greater China. 3D Medicines will obtain the exclusive authorization for development and commercialization activities for AVB-500 in Greater China, and will participate in global clinical trials. 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.

 

When commenting on the collaboration, John Gong, M.D., Ph.D., Chief Executive Officer of 3D Medicines, said, “We are very pleased to enter into this strategic collaboration with Aravive on AVB-500. We believe that AVB-500, the innovative drug targeted at multiple types of cancers, could provide a more convenient and more effective option for cancer patients, if used in combination with existing standard treatment or Envafolimab (KN035, PD-L1 antibody given via subcutaneous injection), our new drug that is about to hit the market. We will work closely with Aravive to further advance the development and commercialization of AVB-500 and bring this highly promising therapy to cancer patients in China as soon as possible.”

 

Gail McIntyre, Ph.D., Chief Executive Officer of Aravive, commented, “We believe 3D Medicines is the best partner for the development and potential commercialization of AVB-500 in China. 3D Medicines has built up the pipeline with both innovative biological and small-molecule anti-tumor drugs, as well as a professional team with the capability of the global R&D, registration and commercialization. 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 as soon as possible, with the goal of improving the cancer treatment landscape across various tumor types.”

 

About AVB-500

AVB-500 is a recombinant fusion protein that targets GAS6-AXL signaling pathway, which is upregulated in multiple cancer types including ovarian cancer and correlated with decreased survival and tolerance for traditional treatment. As has been proven by preclinical models, AVB-500 neutralizes GAS6 by binding to it, thus selectively inhibiting the GAS6-AXL signaling pathway. 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. Taking “help people with cancer live longer and better” as our concept, 3D Medicines aims at the trend of managing cancer as chronic illness and focuses on the development of differentiated immuno-oncology drugs, helping the cancer patients to live with prolonged survival time and a better quality of life. 3D Medicines has established a pipeline with both antibody and small-molecule anti-cancer drugs, as well as a professional team capable of global development, registration and commercialization operation for new drugs.

 

About Aravive

Aravive, Inc. is a clinical-stage oncology company devoted to innovative cancer treatment. 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 next pivotal Phase 3 trial. During the Phase 1b trial of AVB-500 in platinum resistant ovarian cancer, all 5 patients in the 15 mg/kg cohort experienced clinical benefit, with 1 complete response, 2 partial responses, and 2 stable disease. Aravive also intends to initiate a Phase 1b/Phase 2 trial of AVB-500 in clear cell renal cell carcinoma later this year.