Kyowa Hakko - KYKOY STOCK NEWS

Kyowa Kirin announced new data demonstrating the long-term benefits of CRYSVITA (burosumab) for adults with X-linked hypophosphataemia (XLH) after 96 weeks of therapy. The study, a randomized, double-blind, placebo-controlled phase 3 trial, showed significant improvements in pain, stiffness, fatigue, and physical function. Patients exhibited increased serum phosphorus levels and enhanced mobility as measured through PROs and the 6-minute walk test.

These results underscore Kyowa Kirin's commitment to addressing the needs of XLH patients.

Kyowa Kirin launched initiatives to enhance understanding of mycosis fungoides (MF) and Sézary syndrome (SS), both subtypes of cutaneous T-cell lymphoma (CTCL), focusing on the role of POTELIGEO (mogamulizumab-kpkc). The omni-channel campaign, Treat the Blood. Treat the Skin., aims to educate physicians on the significance of blood involvement in treatment decisions, with patient testimonials shared through various media. The launch aligns with Blood Cancer Awareness Month, emphasizing the importance of routine blood testing for improving patient outcomes in MF and SS.

Kyowa Kirin Co., Ltd. announced detailed data from a Phase 2 study of KHK4083/AMG 451, a potential first-in-class anti-OX40 monoclonal antibody for treating atopic dermatitis. The findings will be highlighted at the EADV Congress from September 29 to October 2, 2021. The study involved 274 patients, assessing its efficacy and safety through the Eczema Area and Severity Index (EASI) over 16 weeks. KHK4083/AMG 451 leverages advanced POTELLIGENT technology to enhance immune responses and is a collaborative development with Amgen, which will lead global commercialization outside of Japan.

Amgen (NASDAQ: AMGN) announced new data from its inflammation pipeline will be presented at the EADV 30th Congress from Sept. 29 to Oct. 2, 2021. Key highlights include late-breaking results from a Phase 2 study of AMG 451/KHK4083, a potential treatment for moderate-to-severe atopic dermatitis, and new data from the Phase 3 ADVANCE trial on Otezla's efficacy for plaque psoriasis. Amgen aims to share insights into innovative treatments for patients with severe skin conditions, reflecting its commitment to dermatologic diseases advancement.

Kyowa Kirin announced that it will present detailed data from the Phase 2 study of KHK4083/AMG 451, an anti-OX40 monoclonal antibody, at the European Academy of Dermatology and Venereology Congress from September 29 to October 2, 2021. This treatment targets moderate to severe atopic dermatitis, with implications for other autoimmune diseases. The study involved 274 patients and focused on the efficacy and safety of KHK4083/AMG 451, which utilizes Kyowa Kirin's advanced POTELLIGENT technology to enhance antibody activity. The presentation is scheduled for October 2, 2021.

MEI Pharma and Kyowa Kirin announced the dosing of the first patient in the Phase 3 COASTAL study, evaluating zandelisib, a selective PI3Kδ inhibitor, alongside rituximab for relapsed or refractory follicular and marginal zone lymphomas. This study aims to enroll 534 patients and will compare zandelisib plus rituximab to standard chemotherapy. The primary endpoint is progression-free survival, with the results intended to support marketing applications for zandelisib in the U.S. and globally.

On July 22, 2021, Kyowa Kirin announced promising results from the MAVORIC trial for POTELIGEO (mogamulizumab-kpkc) in treating mycosis fungoides (MF) and Sézary syndrome (SS). The study revealed significantly improved outcomes for patients with higher blood involvement, with progression-free survival of 7.7 months for mogamulizumab versus 3.1 months for vorinostat (P<0.0001). The overall response rate was 28.0% for mogamulizumab compared to 4.8% for vorinostat. This analysis underscores the importance of monitoring blood involvement to optimize treatment strategies.

MEI Pharma and Kyowa Kirin have initiated the second arm of the global Phase 2 TIDAL study, dosing the first patient with relapsed or refractory marginal zone lymphoma. This arm evaluates zandelisib, a PI3K delta inhibitor, alongside a previous arm focusing on follicular lymphoma. Both arms aim for separate FDA accelerated approval applications. The study will assess objective response rates and tolerability of zandelisib. This collaboration between the companies highlights their commitment to advancing therapeutic options for patients with B-cell malignancies.

Amgen and Kyowa Kirin have announced a global collaboration to jointly develop KHK4083, a potential first-in-class treatment for moderate-to-severe atopic dermatitis. Amgen will lead the development and commercialization worldwide, except in Japan, where Kyowa Kirin retains rights. The agreement includes a $400 million upfront payment from Amgen and additional milestone payments up to $850 million. KHK4083 has shown promising Phase 2 results, significantly improving symptoms in patients. The partnership builds on a long history of collaboration, leveraging Amgen's expertise and Kyowa Kirin's innovative technology.