Kyowa Hakko - KYKOY STOCK NEWS

MEI Pharma announced promising data from the zandelisib clinical development program presented at the 2022 European Hematology Association Hybrid Congress. The Phase 2 TIDAL study reported a 70.3% objective response rate and a 35.2% complete response rate in patients with relapsed or refractory follicular lymphoma. Notably, 87.5% of responses occurred within the first two therapy cycles. Adverse events led to a 9.9% discontinuation rate, primarily consisting of Grade 3 AEs. The study aims to continue assessing zandelisib's safety and efficacy as enrollment progresses in additional cohorts.

MEI Pharma and Kyowa Kirin presented data from the ongoing Phase 2 TIDAL study on zandelisib at the ASCO 2022 Annual Meeting. The study showed a 70.3% objective response rate and a 35.2% complete response rate among patients with relapsed or refractory follicular lymphoma. Notably, 87.5% of responses occurred within the first two cycles of therapy. Safety data indicated that 9.9% of patients discontinued for drug-related adverse events, with 83% reporting Grade 3 adverse events primarily in initial treatment cycles. The results support the continued development of zandelisib, particularly in the Phase 3 COASTAL study.

MEI Pharma, Inc. (NASDAQ: MEIP) and Kyowa Kirin Co., Ltd. announced the presentation of Phase 2 TIDAL study data on zandelisib at the ASCO 2022 Annual Meeting, scheduled for June 3-7, 2022. The study evaluates the efficacy and safety of zandelisib, a PI3Kδ inhibitor for treating B-cell malignancies. The abstract ID is 7511, with a poster discussion led by Dr. Andrew David Zelenetz on June 4. MEI Pharma focuses on developing innovative cancer therapies, aiming for FDA approvals for its clinical-stage assets.

LUCA Science and Kyowa Kirin have announced a research collaboration to develop innovative treatments for mitochondrial diseases using LUCA's proprietary mitochondrial therapy platform. Mitochondrial diseases, affecting organs with high energy needs, currently have no definitive cures, only symptomatic treatments. This partnership aims to leverage Kyowa Kirin's drug discovery expertise with LUCA's technology to address the unmet medical needs in mitochondrial therapeutics, as highlighted by both companies’ executives.

MEI Pharma (NASDAQ: MEIP) and Kyowa Kirin (Tokyo: 4151) announced that two abstracts regarding zandelisib, a PI3Kδ inhibitor for B-cell malignancies, will be presented at the European Hematology Association (EHA) 2022 Hybrid Congress from June 9-17, 2022. Oral presentation on June 11 will focus on the efficacy and safety of zandelisib in relapsed or refractory follicular lymphoma, while a poster on June 10 will discuss results from a multi-arm Phase 1b study. These presentations may support future FDA marketing approvals.

La Jolla Institute for Immunology and Kyowa Kirin, Inc. have renewed their collaboration through a three-year agreement, enhancing their longstanding partnership. The new funding will increase annual support for research projects, emphasizing human translational potential and faculty recruitment. Kyowa Kirin will have first rights to negotiate licenses for discoveries resulting from the funded projects. This collaboration aims to fuse Kyowa Kirin's drug development capabilities with LJI's immunology expertise to accelerate the introduction of new therapies.

Cumberland Pharmaceuticals (NASDAQ: CPIX) has acquired SANCUSO^® (granisetron transdermal patch) from Kyowa Kirin for $13.5 million, with additional milestone payments and royalties up to 10% on U.S. net sales. SANCUSO is the only FDA-approved patch for preventing chemotherapy-induced nausea and vomiting, with U.S. sales exceeding $14 million in 2020. This acquisition allows Cumberland to enhance its oncology portfolio, addressing the needs of the approximately 500,000 Americans undergoing chemotherapy each year.

Amgen and Kyowa Kirin announced positive Phase 2 study results of AMG 451/KHK4083 for treating moderate-to-severe atopic dermatitis, presented at EADV 2021. The study, involving 274 patients, met its primary endpoint with significant improvements in Eczema Area and Severity Index (EASI) scores across all treatment groups compared to placebo. Key secondary endpoints also showed positive outcomes. Adverse events were generally mild. Future Phase 3 trials are anticipated to further validate these promising findings, with potential implications for over 30 million affected individuals.

Kyowa Kirin and Amgen announced positive results from a Phase 2 study of KHK4083/AMG 451 for moderate-to-severe atopic dermatitis, presented at the EADV Congress on Oct. 2, 2021. The study met its primary objective, demonstrating statistically significant improvements in Eczema Area and Severity Index (EASI) scores at 16 weeks across all treatment groups compared to placebo. Patients continued to show efficacy improvements beyond 16 weeks, with common adverse events being mild to moderate. Phase 3 trials are expected to begin in the first half of 2022.