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Alphamab Oncology Completes Dosing for First Patient in KN019 Phase II Clinical Trial for Rheumatoid Arthritis Treatment

December 27, 2019 16:00 Eastern Daylight Time

Alphamab Oncology (Stock code: HK 9966) recently announced that the first patient has been successfully dosed in a phase II clinical trial (“KN019-201”) of KN019, a CTLA-4-based immunosuppressant fusion protein drug candidate.


KN019, self-developed by Alphamab Oncology, is a CTLA-4-based immunosuppressant fusion protein drug candidate. Globally, the only two approved CTLA-4-Fc fusion proteins are Nulojix (belatacept) and Orencia (abatacept). KN019 is the only CTLA-4-Fc fusion protein candidate in China with the same amino acid sequence as belatacept. Alphamab Oncology plans to develop KN019 for a variety of indications including autoimmune diseases, kidney transplant rejection and oncology supportive care.


Currently, the phase I clinical trial for KN019 completed in China has exhibited favorable safety and Pharmacokinetics (PK) profiles in healthy subjects. The KN019-201 trial is a phase II clinical trial conducted in China to evaluate the efficacy and safety of KN019 in patients with active rheumatoid arthritis inadequately addressed by prior treatment of MTX. The trial is led by Professor Xiaofeng Zeng from Peking Union Medical College Hospital Rheumatology and immunology Department, with plans to be conducted in around 20 research centers and recruit 141 patients.


Professor Xiaofeng Zeng previously has participated multiple national or international multicenter clinical studies, with extensive experience in rheumatology and immunology. Professor Zeng said, “KN019 is a biosimilar to belatacept produced in China. Its phase I data has shown the similarity with the original drug. We hope that the phase II study could provide new treatment options for rheumatoid arthritis subjects.”


Dr Ting Xu, the Founder, Chairman & CEO, commented, "Rheumatoid arthritis (RA) is an autoimmune disease with progressive deformity and disability, which seriously affects the patients’ quality of life. Based on the good safety and PK profiles of KN019 in previous studies, we look forward to further development and verification of its value in RA patients and bringing benefits to patients. "



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.