Kyowa Kirin to Present Atopic Dermatitis Clinical Data from KHK4083/AMG 451 Phase 2 Study at The European Academy of Dermatology and Venereology 30th Congress
13.9.2021 16:00:00 EEST | Business Wire | Press release
Kyowa Kirin Co., Ltd. (TSE:4151, President and CEO: Masashi Miyamoto, “Kyowa Kirin”) , a global specialty pharmaceutical company creating innovative medical solutions utilizing the latest biotechnology, today 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.
Presentation Title:
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
Submission Topic: 5. Atopic Dermatitis/Eczema
Session date and time: Saturday 2 October 2021, 10.00 - 11.00(CEST)
Primary Author: Emma Guttman-Yassky, M.D./Ph.D., System Chair for the Department of Dermatology and Waldman Professor of Dermatology and Immunology, Icahn School of Medicine at Mount Sinai and Director of the Center for Excellence in Eczema, and the Laboratory of Inflammatory Skin Diseases at Mount Sinai.
The abstract will be available on the EADV Congress website.
The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.
About KHK4083/AMG 451
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.
An overview of the KHK4083/AMG 451 Phase 2 Study
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. The primary endpoint of the study was "percent change from baseline in Eczema Area and Severity Index (EASI) 1 at 16 weeks”.
About OX40
OX40 is a co-stimulatory molecule and a member of the tumor necrosis factor receptor (TNFR) superfamily. It has been reported that activated effector T cells express OX402,3 and are present in the lesions of patients with atopic dermatitis4. Professor Michael Croft, Ph.D., who is Director, Scientific Affairs, La Jolla Institute for Immunology helped identify that OX40 plays an important role in T cell proliferation, survival and formation of memory T cells5.
About Kyowa Kirin
Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company with a more than 70-year heritage, we apply cutting-edge science including expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions – Japan, Asia Pacific, North America and EMEA/International – we focus on our purpose, to make people smile, and are united by our shared values of commitment to life, teamwork/Wa, innovation, and integrity. You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com/.
Kyowa Kirin International is a subsidiary of Kyowa Kirin Co., Ltd.
References
- Hanifin JM.; Thurston M.; Omoto M.; Cherill R.; Tofte SJ.; Graeber M: The eczema area and severity index（EAS）: assessment of reliability in atopic dermatitis. EASI Evaluator Group: Exp Dermatol, 2001; 10: 11-18.
- Croft, M.; So, T.; Duan, W.; Soroosh, P.: The significance of OX40 and OX40L to T-cell biology and immune disease. Immunol: Rev. 2009, 229, 173–191.
- Croft, M. Control of Immunity by the TNFR-Related Molecule OX40 (CD134): Annu. Rev. Immunol. 2010, 28, 57–78.
- Masutaka F.; Mihoko F. OX40L–OX40 Signaling in Atopic Dermatitis: J. Clin. Med. 2021, 10, 2578
- Gramaglia I; Jember A; Pippig SD; Weinberg AD, Killeen N; Croft M: The OX40 Costimulatory Receptor Determines the Development of CD4 Memory by Regulating Primary Clonal Expansion: J Immunol 2000: 165 (6) 3043-50; DOI: 10.4049/jimmunol.165.6.3043
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210913005356/en/
Contact information
Hiroki Nakamura (Global, Japan), +81-3-5205-7205
Lauren Walrath (North America), +1-646-526-4454
Stacey Minton (EMEA), +44 (0) 7769 65607
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
RoslinCT Awarded £7.25 million Scottish Enterprise R&D Grant to Advance Digital Cell Therapy Manufacturing6.10.2026 09:00:00 EEST | Press release
RoslinCT, a leading global cell therapy Contract Development and Manufacturing Organization (CDMO), today announced it has been awarded a Research & Development grant from Scottish Enterprise to accelerate the digital transformation of its manufacturing operations in Scotland. The funding, supported by a Scottish Enterprise R&D grant of up to £7.25 million, forms part of RoslinCT's ambitious digital expansion plan, a multi-year initiative designed to enhance the company's integrated digital and AI capabilities and further strengthen Scotland's position as a global hub for advanced cell and gene therapy manufacturing. The programme will enable the development of a digitally integrated manufacturing environment, improving operational efficiency, data connectivity and manufacturing excellence across RoslinCT's operations. By creating a more connected and data-driven manufacturing environment, RoslinCT will be better positioned to support clients throughout the product lifecycle, helping b
30 Years of Restylane ® : Reshaping the Aesthetics Field Through Science-Led, Patient-Centric Innovation6.10.2026 08:00:00 EEST | Press release
Galderma (SIX: GALD), the pure-play dermatology category leader, celebrates 30 years since Restylane was launched in Europe as the first hyaluronic acid (HA) injectable.1 With HA closest to the skin’s own, Restylane is designed to deliver personalized, natural-looking outcomes that meet diverse patient needs across key areas of the face, décolletage, and hands.8,10,12,21-31 With three decades of innovation across technology, packaging, and treatment areas, Restylane remains at the forefront of innovation, evolving from its original NASHA®, technology into a comprehensive portfolio spanning three distinct technologies: NASHA HD™, NASHA®, and OBT™.1,8,21,22 Together, these technologies offer solutions ranging from firmer gels that provide contouring and structural support, to soft, flexible formulations that smooth facial lines and wrinkles for a more youthful look.8,12,21-31 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/202610
Posiflex Unveils AI-Powered SCO Series Kiosk to Accelerate the Future of Self-Service Retail6.10.2026 05:33:00 EEST | Press release
Posiflex Technology, Inc., a global leader in Point of Sale (POS) systems and Online-to-Offline (O2O) solutions, proudly introduces the SCO Series Self-Service Kiosks, an AI-powered platform designed to redefine self-service retail by offering flexible system configurations that support either precise weighing-scale transactions or RFID-enabled automated checkout. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261004628458/en/ Posiflex Unveils AI-Powered SCO Series Kiosk to Accelerate the Future of Self-Service Retail Built to address the evolving needs of both traditional fresh-goods environments and modern RFID-driven retail concepts, the SCO Series enables retailers to elevate operational accuracy, accelerate checkout processes, and future-proof store deployments through modular architecture, intelligent automation, and adaptable form factors engineered for next-generation retail. AI-Enabled Self-Checkout Solution for Wei
Cities Integrating AI Into Public Services With No Common Framework for Assessing Readiness, Oxford Insights Finds6.10.2026 05:00:00 EEST | Press release
Cities are integrating artificial intelligence into public services and operations with no shared framework for measuring or comparing how prepared they are to do so safely, effectively or accountably. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261005281462/en/ Cover of Oxford Insights' latest report on City AI Readiness. (Graphic: AETOSWire) Existing global indices compare countries on legislation, investment and research output, but the AI efforts happening at city level – the level of government where the technology most directly shapes daily life – are not systematically captured. To start closing that gap, Oxford Insights researchers studied AI readiness across six cities. They found that all share the same core priorities, from governance and funding to talent and infrastructure, but take distinct routes to AI readiness, shaped both by structural conditions and by deliberate strategic choices. The findings draw on
NEG Develops “BDX-3,” a New Starveil™ Ultra-thin Cover Glass for a Wider Range of Space Environments6.10.2026 04:00:00 EEST | Press release
Nippon Electric Glass Co., Ltd. (NEG) (TOKYO: 5214) has developed “BDX-3,” a new Starveil™ ultra-thin cover glass for space applications. BDX-3 is designed to reduce radiation-induced discoloration while providing greater ultraviolet (UV) shielding performance than BDX-2. While primarily intended for low Earth orbit (LEO), it can also be used in medium Earth orbit (MEO) and high Earth orbit, making it suitable for a wider range of space environments. Samples are now available for purchase, and NEG aims to achieve commercial adoption of BDX-3 in satellites and other spaceborne equipment. About BDX-3 Satellites and other equipment operating in space are exposed to intense UV radiation and other forms of radiation. Low Earth orbit is widely used for Earth observation and communications, medium Earth orbit for positioning systems, and high Earth orbit for communications and weather observation. Cover glass used in these environments must not only protect precision equipment from harsh cond
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom