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
Lufthansa Selects Alcohol-Free Gewürztraminer Made with Solos Technology for Premium Allegris Business Class Experience11.11.2026 12:55:00 EET | Press release
Lufthansa has selected BREAKAWAY Gewürztraminer, an alcohol-free wine from German winery Bergdolt-Reif & Nett, for its Allegris Business Class. Made using Solos technology, the wine was chosen following a blind tasting and is scheduled to be served from November 2026 to January 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261111810839/en/ BREAKAWAY Gewürztraminer by Bergdolt-Reif & Nett, made with Solos technology. The selection marks a milestone for both partners, bringing their expertise to Lufthansa's premium passengers. Where winemaking meets innovation BREAKAWAY Gewürztraminer is made from a late-harvest wine, chosen for its distinctive aromatic character. Bergdolt-Reif & Nett, a fifth-generation family winery in Germany's Palatinate region, has developed alcohol-free wines since 2022. "That the wine impressed in a blind tasting is the most important point for me," says Christian Nett, winemaker and Managing Dir
Quectel Expands 5G Antenna Portfolio With Ten Versatile Combo Solutions, From Compact 2-In-1 to Rugged 9-In-1 Designs11.11.2026 11:00:00 EET | Press release
Quectel Wireless Solutions, a global IoT solutions provider, today announces ten external combo antennas that combine 5G with GNSS, Wi-Fi or both in a single housing. Instead of specifying, fitting and testing a separate antenna for each radio, device makers can choose one unit matched to the size, technology mix and operating environment of their deployment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261111461614/en/ Quectel expands 5G antenna portfolio with ten versatile combo solutions, from compact 2-in-1 to rugged 9-in-1 designs Across the family, each antenna combines multiple omnidirectional elements with high isolation between them to limit self-interference. Most models cover 5G from 600MHz to 6000MHz and remain backward compatible with 4G, 3G, 2G, LTE Cat-M and NB-IoT networks. All support screw mounting, some also adhesive mounting, and housings are built for outdoor use with ratings from IP65 up to IP69K. “Ev
Quectel SP900BF-AP Smart Module Sets the Pace for Edge AI with 100 TOPS of Computing Power11.11.2026 11:00:00 EET | Press release
Quectel Wireless Solutions, a global end-to-end IoT solutions provider, today announced the SP900BF-AP, a smart module that lets robots, inspection systems and edge gateways run large AI models on the device itself. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261111252890/en/ Quectel SP900BF-AP smart module sets the pace for Edge AI with 100 TOPS of computing power Built on the Qualcomm Dragonwing™ IQ-9075 Processor and delivering up to 100 TOPS of on-device AI compute, the module enables industrial OEMs to integrate advanced AI directly into their products, reducing latency, bandwidth costs and data privacy risks associated with cloud-based processing. By processing data locally, manufacturers can support real-time robotics, automated inspection and other demanding industrial applications while retaining greater control over sensitive production data. Long-term hardware availability also helps meet the extended product l
Lattice and NXP Deliver Flexible, Secure Computing Solution for the Industrial Edge10.11.2026 23:00:00 EET | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable and platform firmware leader, today announced the Lattice NXP PCIe® Companion solution, jointly enabled and promoted with NXP® Semiconductors. Pairing NXP’s i.MX 95 applications processor with Lattice Nexus™-based FPGAs over PCIe, the solution addresses the real-time connectivity, deterministic I/O, and security challenges in industrial automation, robotics, and intelligent edge applications. The joint solution is available in Lattice CertusPro™-NX or Lattice Certus™-NX configurations as companion chips to NXP i.MX 95 SoC compute processors, deepening a long-standing collaboration between Lattice and NXP spanning industrial, data center, and networking applications. The Lattice FPGA adds low latency, deterministic I/O alongside the NXP applications processor, delivering combined capabilities across real-time processing, AI, and custom I/O to help customers modernize aging designs for new interface standards. It supports e
FDA Approves PIMJETMI ® (pimicotinib) for Patients with Tenosynovial Giant Cell Tumor10.11.2026 20:14:00 EET | Press release
Merck, a leading science and technology company, announced today that the U.S. Food and Drug Administration (FDA) has approved PIMJETMI® (pimicotinib), a once-daily oral colony stimulating factor-1 receptor (CSF-1R) inhibitor, as a systemic treatment for adults with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection may cause worsening functional limitation or severe morbidity. “People living with TGCT have long faced difficult treatment decisions as they navigate a disease that can significantly affect their daily lives including their mobility,” said Danny Bar-Zohar, CEO Healthcare and Member of the Executive Board for the Healthcare business of Merck. “Translating scientific innovation into clinically meaningful advances for people living with rare tumors is a strategic imperative for our company, as we continue our commitment to addressing significant unmet needs. With the approval of PIMJETMI in the U.S., we strengthen our leadership position and growing
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