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
Aidoptation Receives Approval for First Fully Autonomous Driving Tests on Highways in the European Union9.7.2026 09:32:00 EEST | Press release
Aidoptation BV, the autonomous vehicle technology company headquartered at DronePort in Sint-Truiden, has received official approval from the Federal Public Service Mobility (FOD) and Transport and the Flemish Agency for Roads and Traffic (AWV) to conduct fully autonomous driving tests on public highways. The permit covers 100 km on the E313 and E314 highways in the province of Limburg, and marks the first time a Level 4 fully autonomous driving system will be tested at highway speeds on public roads in the European Union. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708112110/en/ Our car driving on the highway (in manual mode). Within the global automotive industry, Level 4 is defined as autonomous driving capable of performing all driving tasks and monitoring the environment without any human intervention. This level of autonomy is distinct from the Advanced Driver Assistance Systems (ADAS) that have been tested by se
FIFA World Cup™ Fans Embrace Referee View as Lenovo AI Brings Viewers Closer to the Pitch9.7.2026 07:00:00 EEST | Press release
New international research from Lenovo reveals that technological advancements are fundamentally changing how fans experience the FIFA World Cup 2026™, making viewers feel closer to the action than ever before. According to a survey of football fans across Australia, Canada, India, U.K., U.S., 87% say technology is improving their viewing experience, and 84% report the close-to-action camera perspectives help them feel like they're right there on the pitch. Accelerating this unprecedented view of the game is Referee View, powered by Lenovo AI that gives viewers a first-person look at the match from the referee’s point of view. The research further found: Over three-quarters (76%) of FIFA World Cup™ viewers have seen or heard about Referee View, and 91% say the close-to-action perspective is appealing. 88% say that smooth, stable footage is an important part of viewing sports footage, and nearly all fans (98%) say clear picture quality has been important when watching this FIFA World Cu
Empire State Building Observation Deck Launches Exclusive Soccer Jersey Ticket Offer for Sports Fans in July9.7.2026 01:37:00 EEST | Press release
The Empire State Building Observation Deck (ESBOD) today announced a new, exclusive ticket offer for soccer fans who don their favorite team’s duds at the “World’s Most Famous Building” in anticipation of the tournament final. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708711923/en/ Empire State Building Observation Deck Launches Exclusive Soccer Jersey Ticket Offer for Sports Fans in July Guests who plan to wear their soccer jersey to the Empire State Building Observation Deck can purchase tickets online for 15 percent off to enjoy the immersive museum experience and New York City’s best views from the 86th and 102nd Floor Observation Decks. The limited-time offer is available only to guests who wear their soccer jersey on the day of their visit from now through July 31. “Whether they rep their favorite country’s jersey or the shirt from their hometown heroes, guests can celebrate their teams with prime views of the
New Esri Press Book Shows That GIS Can Transform the Entire Campus, Starting at the Classroom9.7.2026 00:33:00 EEST | Press release
Esri has released The Spatial Edge: The Strategic Advantage of GIS Skills Across Higher Education, a practical and accessible guide that demonstrates how geographic information system (GIS) technology can unify campuses academically and operationally. While GIS is often associated with disciplines such as geography, planning, and environmental studies, The Spatial Edge expands that view through real-world case examples. The book shows how spatial thinking can connect departments; strengthen decision-making; and help institutions address complex challenges across teaching, research, and campus operations. Designed for administrators, educators, and campus leaders, the guide highlights GIS being used across higher education to: Enhance teaching and student engagement Advance interdisciplinary research Improve campus planning and operations Strengthen community partnerships Prepare graduates with in-demand geospatial skills From the classroom to facilities management, The Spatial Edge ill
Jefferies Financial Group Inc. Announces Pricing of €850,000,000 4.500% Senior Notes Due 20338.7.2026 23:16:00 EEST | Press release
Jefferies Financial Group Inc. (NYSE: JEF) (“JFG”, “we” or “our”) today announced the pricing of its public offering of €850,000,000 aggregate principal amount of 4.500% Senior Notes due 2033 (the “Notes”) with an effective yield of 4.544%, maturing, July 15, 2033. The offering is expected to settle on July 15, 2026, subject to the satisfaction of customary closing conditions. Application is expected to be made for the Notes to be admitted to the Official List of the Irish Stock Exchange plc, trading as Euronext Dublin, and admitted to trading on the Global Exchange Market of Euronext Dublin; any listing is subject to approval by Euronext Dublin. JFG intends to use the net proceeds of the offering for general corporate purposes. Jefferies International Limited served as sole global co-ordinator and joint active book-runner for the offering of the Notes, Banco Santander, S.A., Citigroup Global Markets Limited, Natixis, SMBC Bank International plc and Société Générale served as joint act
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