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Alphamab Oncology Reaches Partnership Agreement with 3D Medicines and TRACON Pharmaceuticals for development and commercialization of KN035 in Soft Tissue Sarcoma in North America

December 18, 2019 09:00 Eastern Daylight Time

Suzhou, December 20, 2019 – Jiangsu Alphamab Biopharmaceuticals Co., Ltd. (“Jiangsu Alphamab”, or “the Company”), a wholly owned subsidiary of Alphamab Oncology (Stock code: 9966.HK), announced today that it has signed a collaborative partnership agreement with 3D Medicines and TRACON Pharmaceuticals (“TRACON”) for the clinical development and commercialization of KN035, a PD-L1 single-domain antibody, for soft tissue sarcoma in North America.


KN035 is a PD-L1 single-domain antibody independently discovered by Jiangsu Alphamab. It is expected to become the world’s first PD-L1 immuno-oncology drug that can be administered by subcutaneous injection. The Company and 3D Medicines have co-developed the product to late clinical stage. In this three-party cooperation, TRACON will be responsible for the clinical development and commercialization of KN035 for the treatment of soft tissue sarcomas in North America and pay sales-based royalties to the Company and 3D Medicines. The Company will supply KN035 at pre-negotiated prices.


Dr. Ting Xu, Founder, Chairman and CEO of Alphamab Oncology, said, “The collaboration is an important part of KN035 global development strategy. As the most advanced single domain antibody in Immuno-oncology with advantage of subcutaneous adminstration, we are confident it will become a valuable option for cancer patients.”


John Gong, CEO of 3D Medicines, commented, “In earlier clinical trials, the safety and efficacy profiles of KN035 are comparable to other PD-1/PD-L1 antibodies in the market. Currently the registration trial in MSI-H patients is ongoing, and we believe that KN035 will give cancer patients a better option with subcutaneous injection in the United States.”


Charles Theuer, M.D., Ph.D., President and CEO of TRACON, added, “Given the activity of other PD-1 and PD-L1 inhibitors in sarcoma, we believe a registration enabling study of KN035 in the sarcoma subtype of UPS will be meaningful to patients and providers, and is strategically aligned with TRACON’s mission to rapidly develop and commercialize drugs targeting unmet medical need indications in the U.S. We expect to discuss our plan of initiating a pivotal trial of KN035 in UPS with the U.S. FDA in early 2020. Our ultimate goal is to enable a biomarker directed approach for treatment with KN035 in patients with multiple types of soft tissue sarcoma.”  



About KN035

KN035 is a fusion protein of PD-L1 domain antibody with the Fc domain of a regular antibody. Based on its unique design, KN035 has advantages in safety, convenience, and compliance over conventional PD-(L)1 antibodies. It can be used for patients who are not suitable for intravenous infusion, and has lower medical costs. Currently, KN035 is undergoing clinical trials in China, the United States, and Japan for multiple tumor indications, and it has entered phase III clinical trials for some indications.


About Alphamab Oncology(Stock code: 9966.HK)

Alphamab Oncology is a leading clinical-stage biopharmaceutical company in China with fully integrated proprietary biologics platform in bi-specifics and protein engineering. Its highly differentiated in-house pipeline consists of eight anti-cancer drug candidates, four of which have advanced into clinical development phase. With multiple in-house proprietary platforms for innovative biopharmaceuticals, Alphamab Oncology has built a robust pipeline in oncology/immunology to benefit cancer patients around the world.

Visit http://www.alphamabonc.com for more information.


About 3D Medicines

3D Medicines is a clinical-stage biopharmaceutical company focused on the development of differentiated next-generation immuno-oncology drugs for cancer patients. The company's current pipeline includes two clinical stage drug candidates: KN035, the world's first subcutaneous PD-L1 antibody (approved by the FDA/NMPA/PMDA for clinical study in 2017); 3D-185, a highly selective FGFR-1/2/3 inhibitor (3D Medicines has the global development rights in oncology and pulmonary fibrosis.) A total of six global clinical trials for KN035 are undergoing simultaneously in the United States, China, and Japan. Two key registration trials are being conducted in China., and it is expected to file BLA for the first indication in 2020. With a professional team in China and the United States, 3D Medicines is capable of conducting global clinical development and registration.

Visit www.3dmedcare.com for more information.


About TRACON

TRACON develops targeted therapies for cancer and ophthalmic diseases. The Company’s clinical-stage pipeline includes: DE-122, the ophthalmic formulation of carotuximab, an endoglin antibody that is being developed for patients with wet AMD through a license to Santen Pharmaceutical Company Ltd.; TRC102, a small molecule drug being developed for the treatment of lung cancer; TRC253, a small molecule drug being developed for the treatment of prostate cancer; and TJ004309, a CD73 antibody being developed for the treatment of advanced solid tumors. TRACON is actively seeking additional corporate partnerships whereby it leads regulatory and clinical development and shares in the cost and risk of clinical development and leads U.S. commercialization. In these partnerships TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the U.S. To learn more about TRACON and its product candidates, visit TRACON's website at www.traconpharma.com.