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
Hexagon Semi’s HX77 AR Display Processor Achieves Ultra-Low Power Consumption with VeriSilicon’s Nano IP Portfolio10.3.2026 02:00:00 EET | Press release
VeriSilicon (688521.SH) today announced that Hefei Hexagon Semiconductor (Hexagon Semi), an image processing SoC provider, has adopted VeriSilicon’s proven IP portfolio in its high-performance HX77 series image processing SoC. The adopted IPs include the GCNanoUltraV 2.5D Graphics Processing Unit (GPU) IP, DW100 DeWarp Processing IP, and DC9200Nano Display Processing IP. The SoC has successfully taped out, achieving a first-pass silicon success. The HX77 series is a highly integrated, low-power image processing SoC based on RISC-V architecture, integrating comprehensive video input/output interfaces, image processing, and system control capabilities. By leveraging an innovative heterogeneous computing architecture and sophisticated power management technology, HX77 has successfully achieved a technological breakthrough that enables 2K@60fps output with mere milliwatt-level power consumption. HX77 has also realized the 3DoF hover feature on end devices through spatial computing. In addi
Operio Group Named Distributor for Schaefer Technologies in the United Kingdom and European Union9.3.2026 23:00:00 EET | Press release
Operio Group has signed a distribution agreement with Schaefer Technologies, a manufacturer of semi-automatic encapsulation equipment. Operio Group, a holding company building a global group of brands serving the solid dose manufacturing industry, will be the official distributor of Schaefer Technologies’ products in the United Kingdom and the European Union. Schaefer Technologies develops semi-automatic capsule filling systems, including equipment that produces banded capsules for liquid and pellet formulations used by nutraceutical and pharmaceutical manufacturers. Leadership from both companies worked together to establish the agreement, including Kevin Schaefer, CEO of Schaefer Technologies Inc., and Alastair Sanderson, Chief Business Development Officer at Operio Group. “Schaefer Technologies is looking forward to our new relationship with Operio Group,” said Schaefer. “Their understanding of the pharmaceutical equipment market makes them a strong partner as we combine our experti
Kinaxis Goes All-In on Innovation at Upcoming Kinexions in Las Vegas9.3.2026 20:00:00 EET | Press release
Registration is officially open for Kinexions North America, the premier global supply chain orchestration conference hosted by Kinaxis® Inc. (TSX: KXS). Taking place June 1–3 in Las Vegas, Nevada, the event brings together supply chain leaders, innovators and practitioners from around the world to explore how organizations can leverage AI-driven strategies and technologies to connect data, people and decisions. After a year defined by market volatility, geopolitical risk and disruption, this year’s conference will focus on how intelligent supply chain orchestration enables organizations to move beyond reactive planning to building true enterprise adaptability. The program promises to be the most immersive and future-forward Kinexions yet, with renowned author, entrepreneur and innovation expert, Peter Hinssen confirmed as a featured keynote address. “Kinexions has always been the place where the best in supply chain come together to calibrate and share ideas, rethink what’s possible a
Radial Selects Riskified to Power Payment Fraud and Refund/Return Protection for Merchant Client Portfolio9.3.2026 16:00:00 EET | Press release
Riskified (NYSE: RSKD), a leader in ecommerce fraud and risk intelligence, today announced a strategic partnership with Radial, a leading 3PL set to become Paxon later this year. Radial will integrate with Riskified’s AI-powered platform to help its merchants approve more legitimate orders and reduce losses from payment fraud, including many merchants that use Shopify as their ecommerce platform. Radial supports many of the world’s most recognized retail brands with a global ecommerce fulfillment network of more than 20 centers across North America, helping merchants deliver orders quickly and cost effectively. By bringing Riskified’s AI-powered fraud decisioning into its commerce ecosystem, Radial gives merchants the surgical ability to calibrate the checkout experience according to risk—without slowing fulfillment. This also supports brands seeking to expand into new markets. Riskified empowers Radial's customers with accurate, real-time fraud decisions at checkout, approving or decl
Andersen to Announce Fourth-Quarter and Full-Year 2025 Financial Results9.3.2026 16:00:00 EET | Press release
Andersen Group Inc. (NYSE: ANDG) (“Andersen”), a leading provider of independent tax, valuation and financial advisory services to individuals and family offices, businesses and funds in the United States, will announce its financial results for the full year and fourth quarter 2025 after the market closes on Tuesday, March 17, 2026. Andersen CEO and Chairman, Mark L. Vorsatz, and Andersen Chief Financial Officer, Neal Livingston, will host a conference call to discuss Andersen’s financial results on Tuesday, March 17, 2026 at 5PM ET. Participants can join the webcast at https://event.choruscall.com/mediaframe/webcast.html?webcastid=J3Hvslre. The webcast replay link will be archived on Andersen’s Investor Relations website at investor.andersen.com within a few hours of the event and will remain on the website for six months. About Andersen Andersen is a leading provider of independent tax, valuation and financial advisory services to individuals, family offices, businesses and alternat
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