Adult T-Cell Leukemia-Lymphoma

TOKYO--( BUSINESS WIRE )--Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, President and Representative Director: Daikichiro Kobayashi), a leading Japanese pharmaceutical company specializing in infectious diseases, vaccines, and hematology, announced today that it has established a new office in the Boston area, USA, and is initiating venture investments in the life science and healthcare fields. Through its investment activities, Meiji Seika Pharma aims to discover and develop cutting-edge therapies and contribute to solving unmet medical needs of patients worldwide, reflecting the company’s unwavering commitment to innovation and global health. Meiji Seika Pharma was founded in 1916, started pharmaceutical business in 1946, and has grown to be a leading Japanese pharmaceutical company. The company has been at the forefront of research and development of therapeutics and vaccines for infectious diseases. In December 2023, Meiji Seika Pharma obtained the world’s first marketing approval for a self-amplifying mRNA vaccine against COVID-19 (Kostaive ® ). In addition to its focus on infectious diseases area, Meiji Seika Pharma is dedicated to drug discovery and development in hematology and oncology. The company has developed and launched a selective ROCK2 inhibitor (belumosudil mesilate) for the treatment of chronic GVHD, and an HDAC inhibitor (tucidinostat) for ATLL and PTCL in Japan. As a fully integrated pharmaceutical company, it has over 5,500 employees worldwide. Meiji Seika Pharma will expand its presence in the Boston area by opening a new office and explore venture investments at the center of innovation. Located at CIC Cambridge (One Broadway, Cambridge, MA 02142), the new office will act as a strategic hub, fostering investment opportunities that align with the Meiji Seika Pharma’s current vision for growth and innovation. Meiji Seika Pharma will initiate investments in startups and venture capital firms that focus on drug discovery and innovative platform technology. The office is organized as part of Meiji Pharma USA Inc., a subsidiary of Meiji Seika Pharma. “We are pleased to deepen our expertise in infectious diseases area as well as other focus areas,” said Mr. Daikichiro Kobayashi, President and Representative Director of Meiji Seika Pharma. “Our Boston office will facilitate collaboration with pioneering bioventures and startups, furthering our mission to develop innovative solutions such as groundbreaking therapeutics and beyond the pills.” Meiji Seika Pharma’s challenges into these innovative approaches show its commitment to addressing critical health challenges and improving patient outcomes on a global scale. By leveraging the Boston area’s dynamic ecosystem, the company aims to accelerate its research and development efforts and bring breakthrough therapies to global market.

GALASHIELS, Scotland & MARLOW, England--( BUSINESS WIRE )--Kyowa Kirin International (KKI), a wholly owned subsidiary of Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin) and a Japan-based global specialty pharmaceutical company, announced today the signing of a Promotion and Distribution Agreement with NewBridge Pharmaceuticals for the distribution of its existing rare disease portfolio across the Middle East and North Africa (MENA). Under the terms of the agreement, NewBridge will commercialise CRYSVITA ® (burosumab) for the treatment of X-Linked Hypophosphataemia (XLH) and Tumour-Induced Osteomalacia (TIO), as well as POTELIGEO ® (mogamulizumab) for two subtypes of cutaneous T-cell lymphoma (CTCL), a rare non-Hodgkin’s lymphoma. As part of the agreement, NewBridge will exclusively distribute the two products across MENA countries of Algeria, Iraq, Libya and Jordan. KKI and NewBridge also hope to collaboratively address a number of challenges facing the rare disease community in the region by supporting disease awareness, improving time to diagnosis, and improving access to innovative treatments indicated for rare and orphan diseases. Jeremy Morgan, President of KKI, commented: “At Kyowa Kirin our purpose is to deliver life-changing medicines and make people smile. We are pleased to be entering into this agreement with NewBridge Pharmaceuticals who have a clear mission to transform the lives of MENA patients and their families. With a commitment to delivering life changing value for people impacted by under-diagnosed and under-served diseases, this agreement is key to ensuring patients living with XLH, TIO and CTCL are able to access the medicines they need, and is another positive step on our journey.” "Given the high prevalence of rare diseases in the MENA region, I am personally inspired and proud that we at NewBridge are building on our existing partnership with Kyowa Kirin with the addition of their rare disease products to our region,” added Joe Henein, President & CEO of NewBridge Pharmaceuticals. “This collaboration totally aligns with our mission to provide access to new therapies for patients, aiming to alleviate their suffering and enhancing their quality of life." About CRYSVITA (burosumab) CRYSVITA (burosumab) is a recombinant human monoclonal antibody (mAb) that binds to the protein fibroblast growth factor 23 (FGF23). This has the impact of inhibiting the action of FGF23, allowing phosphate regulation in the body to be restored. 1 About POTELIGEO (mogamulizumab) Mogamulizumab is a first-in-class humanised mAb directed against CC chemokine receptor 4 (CCR4), a protein consistently expressed in both mycosis fungoides and Sézary syndrome 2–4 once mogamulizumab binds to CCR4, it increases attraction of immune cells from the immune system to destroy the cancerous cells. 5 About Kyowa Kirin Kyowa Kirin aims to discover novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients affected by severe and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across our four regions—Japan, Asia Pacific, North America, and EMEA/International. You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com About NewBridge Pharmaceuticals NewBridge Pharmaceuticals is a regional specialty company with a comprehensive pharmaceutical platform of services and expertise, established to bridge the access gap and partner with global pharma and biotech companies to in-license and commercialise innovative therapeutics that address unmet medical needs into the Middle East and North Africa (MENA) regions. For more information, please visit www.nbpharma.com References 1 Electronic Medicines Compendium. Crysvita 10 mg solution for injection. Available from: https://www.medicines.org.uk/emc/product/9779/smpc#gref . Last accessed: November 2023. 2 Ferenczi K, et al. Increased CCR4 expression in cutaneous T cell lymphoma. J Invest Dermatol. 2002;119:1405–10. 3 Yoshie O, et al. Frequent Expression of CCR4 in Adult T-Cell Leukemia and Human T-cell Leukemia Virus Type 1-transformed T cells. Blood. 2002;99(5):1505–11. 4 Ishida T, et al. Clinical Significance of CCR4 Expression in Adult T-cell Leukemia/Lymphoma: Its Close Association With Skin Involvement and Unfavorable Outcome. Clin Cancer Res. 2003;9:3625–34. 5 Duvic M, et al. Mogamulizumab for the treatment of cutaneous T-cell lymphoma: recent advances and clinical potential. Ther Adv Hematol. 2016;7(3):171–174. KKI/INT/KKI/0959 Date of preparation: July 2024

Initiation of cell therapy research and development program for adult T-Cell leukemia / lymphoma (ATLL) TOKYO, July 11, 2024 /PRNewswire/ -- The National Cancer Center (Tokyo, Japan) and The University of Pennsylvania (Philadelphia, PA, USA) have licensed patent rights directed to a chimeric antigen receptor T cell therapy that targets the chemokine receptor CCR4 (CCR4 CAR-T cell therapy) to ARC Therapies Inc. (CEO: Rami Suzuki, Headquarters: Shinjuku-ku, Tokyo), a startup originating from the National Cancer Center. This agreement marks the commencement of ARC Therapies, Inc.'s research and development of a cell therapy targeting T-cell cancers, including adult T-cell leukemia/lymphoma (ATLL), which is prevalent in Japan. Furthermore, the potential application of CCR4 CAR-T cell therapy to solid cancers will also be pursued. The National Cancer Center, established in 1962, is a leading cancer institute in Japan. The University of Pennsylvania pioneered the foundational research and co-development activities that led to the first CAR-T cell approved by the FDA in 2017 and continues to be a leader in CAR-T cell research, including next-generation therapies. ARC Therapies Inc., established in May 2022, is a National Cancer Center Japan-certified startup that promotes the research and clinical development of new cell therapies using cutting-edge research. Hiroyuki Mano, Director of the National Cancer Center Research Institute, commented: "At the National Cancer Center, we are consistently promoting a comprehensive approach from understanding the mechanisms of carcinogenesis to the development of treatment and diagnostic methods for various cancers. We are pleased that one of the outcomes of our international collaborative research, the CCR4 CAR-T cell therapy, has led to a licensing arrangement for the development of potential new treatments by a startup originating from the National Cancer Center. We expect this arrangement to accelerate the practical application of new T-cell therapies originating from the National Cancer Center." Rami Suzuki, CEO of ARC Therapies Inc., commented: "We are committed to the research and development of the CCR4 CAR-T cell therapy licensed from the National Cancer Center and the University of Pennsylvania. The potential long-lasting efficacy of chimeric antigen receptor T cell therapy is well-known, and we hope that our efforts will provide valuable treatment options for cancer patients." Glossary: *1 CCR4: CCR4 is a chemokine receptor primarily expressed on lymphocytes that migrate to the skin. It is found on the surface of cells in Adult T-Cell Leukemia/Lymphoma (ATLL), Peripheral T-Cell Lymphoma (PTCL), and Cutaneous T-Cell Lymphoma (CTCL). The anti-CCR4 antibody "mogamulizumab" is approved as a therapeutic drug for the aforementioned three types of cancer. Additionally, CCR4 is expressed on regulatory T cells surrounding tumors, indicating potential for solid cancer treatment through regulatory T cell removal therapy. *2 CCR4 CAR-T cell therapy: Recombinant T cells will be created by introducing a gene that combines an antibody (single chain) that binds specifically to CCR4 with an intracellular signal transduction domain into leukocytes collected from the patient. When injected into the patient, it is hoped that these cells will migrate and accumulate in tumor tissues expressing CCR4, become activated, and attack the cancer. *3 Adult T-Cell Leukemia/Lymphoma (ATLL): ATLL is a T-cell lymphomas/ lymphoid malignancies (neoplasms) that develops in patients infected with Human T-Cell Leukemia Virus Type 1 (HTLV-1). HTLV-1 infection is observed in specific regions of Japan, making ATLL a characteristic tumor of Japan. The government is focusing on countermeasures as a national issue. Although anti-CCR4 antibody treatment has been successful for blood-type ATLL, recurrence remains a problem, and there is currently no effective treatment for lymphoma-type ATLL. University of Pennsylvania Financial Disclosure: Penn may receive forward-looking financial consideration related to the licensing of certain Penn intellectual property to ARC Therapies, Inc. Enquiries On Research Keisuke Watanabe, MD PhD Senior Staff Scientist at the National Cancer Center Research Institute E-mail: [email protected] Media Inquiries Office of Public Relations, Strategic Planning Bureau, National Cancer Center (Tsukiji Campus) E-mail： [email protected] ARC Therapies Inc. Rami Suzuki CEO of ARC Therapies Inc. E-mail： [email protected] SOURCE ARC Therapies Inc.