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
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.
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”.
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.
- 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.
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
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
EngageSmart Announces Pricing of Initial Public Offering23.9.2021 02:48:00 CEST | Press release
EngageSmart, Inc., a leading provider of vertically-tailored customer engagement software and integrated payments solutions, today announced the pricing of its initial public offering of 14,550,000 shares of its common stock at a price of $26.00 per share. Of the offered shares, 13,000,000 shares are being offered by EngageSmart and 1,550,000 shares are being offered by certain of EngageSmart’s existing stockholders. In addition, the underwriters will have a 30-day option to purchase from EngageSmart and the selling stockholders up to an additional 2,182,500 shares of their common stock at the initial public offering price, less underwriting discounts and commissions. EngageSmart will not receive any proceeds from the sale of shares of common stock by the selling stockholders. The shares are expected to begin trading on the New York Stock Exchange on Thursday, September 23, 2021, under the ticker symbol “ESMT.” The offering is expected to close on September 27, 2021, subject to customa
InvestaX Gets Closer to Tokenizing the World with MAS Fintech Sandbox23.9.2021 02:00:00 CEST | Press release
InvestaX (IC SG Pte Ltd) launches exchange in the Monetary Authority of Singapore (MAS) sandbox, providing key infrastructure for bringing liquidity to digital securities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210922005600/en/ Next Generation Digital Assets (Photo: Business Wire) InvestaX is a Singapore-headquartered, MAS-licensed* online investment and trading platform for Digital Securities (DSO) and Security Tokens (STO) of global private markets deals, focusing on exciting growth industries including crypto, gaming, blockchain, digital assets, venture, private equity and real estate. InvestaX, announces entry in the sandbox for its exchange, and now provides a one-stop shop solution for the issuance and trading of digital securities, for global products and global investors. Targeting the $8T USD tokenization of the private markets, InvestaX is built with open infrastructure for scalability and interoperability,
AWS to Open Data Centers in New Zealand23.9.2021 00:52:00 CEST | Press release
Today, Amazon Web Services (AWS), an Amazon.com, Inc. company (NASDAQ: AMZN), announced plans to open an infrastructure region in Aotearoa New Zealand in 2024. The new AWS Asia Pacific (Auckland) Region will consist of three Availability Zones (AZs) and join the existing 81 Availability Zones across 25 geographic AWS Regions at launch. The Region will be owned and operated by a local AWS entity in New Zealand. Globally, AWS has announced plans for 24 more Availability Zones and eight more AWS Regions in Australia, India, Indonesia, Israel, Spain, Switzerland, the United Arab Emirates, and the new AWS Region in New Zealand. The new AWS Asia Pacific (Auckland) Region will enable even more developers, startups, and enterprises as well as government, education, and nonprofit organizations to run their applications and serve end users from data centers located in New Zealand, ensuring that customers who want to keep their data in New Zealand are able to do so. AWS also released an economic
Procore to Acquire Levelset to Simplify Lien Management Workflows for Construction22.9.2021 22:05:00 CEST | Press release
Procore Technologies, Inc., (NYSE: PCOR), a leading provider of construction management software, has signed a definitive agreement to acquire Levelset. This acquisition will add lien rights management to the Procore platform, enabling Procore to manage complex compliance workflows and improve the payment process in construction. It also presents future growth opportunities for Procore, including capitalizing on the companies’ complementary data assets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210922005931/en/ Burdensome compliance workflows contribute to the construction industry’s median of 90 days sales outstanding and 74 days payable outstanding, the slowest of all industries surveyed across the globe. (Graphic: Business Wire) Procore Founder and CEO Tooey Courtemanche said, “Construction work is hard enough — getting paid shouldn’t be. Levelset helps the construction industry get paid faster, and their offering wi
Leaders in Cloud Adoption Approach Cloud Differently and Achieve 10x Greater ROI, Says Research by Wipro FullStride Cloud Services22.9.2021 18:24:00 CEST | Press release
Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today released a report indicating that leaders in cloud adoption approach their cloud journey differently than beginners, enabling them to achieve a 10x greater annualized return on investment. Wipro’s report, “Making Business Thrive: A Cloud Leader Roadmap for Achieving 10x ROI,” outlines these best practices for enterprises beginning their cloud journey or seeking to accelerate their results. The report also identifies dozens of key cloud-adoption metrics for multiple industries and countries. Wipro FullStride Cloud Services developed the report based on a survey of 1,300 global C-level executives and key decision-makers from 11 industries and six countries (see “Methodology” below). Wipro considered leaders to be the top 19% of respondents based on cloud maturity, while beginners represented the lowest 32%; this was not based on revenue. Thi
Nathan's Famous Continues International Expansion with European Push to Offer Hot Dogs in France22.9.2021 17:57:00 CEST | Press release
Nathan's Famous, Inc., the American tradition serving New York favorites for more than 100 years, announces a new collaboration with Tommy's Diner, a 50's throwback American diner based in France, to offer its hot dogs in all locations across the country, making it the first time Nathan's Famous is served in France. This relationship continues Nathan's Famous growth in Europe and beyond. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210922005823/en/ Nathan's Famous Menu. (Photo: Business Wire) "Nathan's Famous is known the world over, which is why we've had such great success in recent years growing in the Middle East, Asia, and Great Britain," states James Walker, Senior Vice President, Restaurants. "This new relationship with Tommy's is a big step for us as we look to see that growth spread throughout Europe, and we're excited that they are our first French outpost and will be one of the first internationally to have our
IHMA Opens Microbiology Reference Laboratory in Shanghai, China to Further Support Global Anti-Infective Product Discovery and Development22.9.2021 16:30:00 CEST | Press release
IHMA has opened a microbiology reference laboratory in Shanghai, China in February of 2021. This facility will join IHMA locations in the USA, Switzerland and India to allow the company to provide more robust global support for anti-infective product discovery and development. The China facility will provide microbiology testing to support profiling of new antimicrobial products, antimicrobial resistance surveillance, molecular characterization of resistant organisms, and serve as a central laboratory for clinical trials conducted in China. “We have been working for almost 30 years to maximize our in vitro support for clients who are developing anti-infective products globally. Our facility in China will greatly enhance that effort and support clients wishing to conduct studies in this important market,” said Jack L. Johnson, President/CEO of IHMA. About IHMA: As the leading global microbiology service provider to the biopharmaceutical industry, IHMA utilizes its extensive laboratory a