Kyowa Kirin Co., Ltd. to Present Atopic Dermatitis Clinical Data from Khk4083/Amg 451 Phase 2 Study At the European Academy of Dermatology and Venereology 30Th Congress
September 13, 2021 at 09:00 am EDT
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Kyowa Kirin Co., Ltd. announced detailed data from a Phase 2 study of KHK4083/AMG 451 will be highlighted in late-breaking oral presentation at the European Academy of Dermatology and Venereology 30th Virtual Congress to be held September 29 – October 2, 2021. KHK4083/AMG 451 is a potential first-in-class anti-OX40 fully human monoclonal antibody in development for the treatment of atopic dermatitis, with potential in other autoimmune diseases. Efficacy and safety results of KHK4083/AMG 451 (anti-OX40 mAb) in subjects with moderate to severe atopic dermatitis: a phase 2, multicentre, randomized, double-blind, parallel-group, placebo-controlled study
KHK4083/AMG 451 is an anti-OX40 fully human monoclonal antibody engineered with Kyowa Kirin’s patented POTELLIGENT® defucosylation technology to enhance its antibody-dependent cellular cytotoxicity (ADCC) activity. The initial KHK4083/AMG 451 antibody was discovered in collaboration between Kyowa Kirin US Research and La Jolla Institute for Immunology. KHK4083/AMG 451 targets and inhibits the activity of the OX40 receptor expressed on the surface of effector T-cells, and has been shown to deplete activated OX40+ T-cells by ADCC. It has been reported that effector T cells expressing OX40 are present in the lesions of patients with atopic dermatitis and are critical in their development. Kyowa Kirin antibodies powered by POTELLIGENT technology with ADCC activity are currently marketed in several other therapeutic areas, including Oncology and Asthma. This potent antibody-enhancement platform is also licensed to numerous third parties throughout the biopharmaceutical industry. On June 1, 2021, Kyowa Kirin entered into an agreement with Amgen (NASDAQ: AMGN) to jointly develop and commercialize KHK4083/AMG 451. Under the terms of the agreement, Amgen will lead the development, manufacturing, and commercialization for KHK4083/AMG 451 for all markets globally, except Japan, where Kyowa Kirin will retain all rights. If approved, the companies will co-commercialize the asset in the United States and Kyowa Kirin has opt-in rights to co-promote in certain other markets including Europe and Asia. A Phase 2, multicenter, randomized, double-blind, and placebo-controlled clinical study (NCT03703102) was conducted in the U.S., Japan, Canada, and Germany to investigate the efficacy and safety of KHK4083/AMG 451. The study included 274 patients with moderate-to-severe atopic dermatitis, who were not adequately controlled with topical agents.
Kyowa Kirin Co., Ltd. specializes in the development, manufacturing and marketing of pharmaceutical and biochemical products. Net sales break down by source of revenue as follows:
- sales of pharmaceutical products (92.6%): prescription products for anemia, cancers, immune and nephrology diseases treatment;
- sales of licenses (7.4%).
At the end of 2021, the group had 3 production sites located in Japan (2) and China.
Net sales break down geographically as follows: Japan (60.9%), Asia (9%), Americas (16.3%) and Europe (13.8%).
Kyowa Kirin Co., Ltd. to Present Atopic Dermatitis Clinical Data from Khk4083/Amg 451 Phase 2 Study At the European Academy of Dermatology and Venereology 30Th Congress