KYOWA KIRIN CO., LTD.

AstraZeneca to Present Groundbreaking Respiratory Research at ATS 2025 Conference

9 days ago

• AstraZeneca will showcase over 75 abstracts at the American Thoracic Society International Conference, highlighting advancements in asthma and COPD treatments including Airsupra and Breztri. • The BATURA Phase IIIb trial demonstrates Airsupra's potential to transform asthma rescue treatment by reducing systemic corticosteroid exposure compared to albuterol alone. • New data shows prompt initiation of Breztri after COPD exacerbations reduces subsequent exacerbations and cardiopulmonary events, addressing COPD as the third leading cause of death globally.

Kura Oncology Initiates Phase 1 Trial Combining Ziftomenib with Imatinib for Advanced GIST Treatment

24 days ago

• Kura Oncology has dosed first patients in KOMET-015, a Phase 1 trial evaluating ziftomenib in combination with imatinib for advanced gastrointestinal stromal tumors (GIST) after imatinib failure. • Preclinical studies show the combination provides robust antitumor activity in both imatinib-sensitive and imatinib-resistant GIST models through a synthetic lethal mechanism targeting tumor vulnerabilities. • With approximately 60% of GIST patients developing imatinib resistance within two years, this novel menin inhibitor combination represents a potential breakthrough for the estimated 4,000-6,000 new GIST cases diagnosed annually in the U.S.

Kyowa Kirin and La Jolla Institute Extend 35-Year Research Alliance with Focus on Cell and Gene Therapies

2 months ago

• The 35-year partnership between Kyowa Kirin and La Jolla Institute for Immunology has been renewed for three more years, representing one of the longest-standing industry-academic collaborations in drug discovery. • The alliance has already produced significant advances in immunology research, including a promising immunotherapy for atopic dermatitis currently in Phase III clinical trials. • The renewed agreement will prioritize development of cell and gene therapies for diseases with limited treatment options, with preliminary clinical data for several compounds expected in 2025.

Kura Oncology's KO-2806 Shows Promise in Combination Therapy for Renal Cell Carcinoma

2 months ago

• Preclinical data for Kura Oncology's next-generation farnesyl transferase inhibitor KO-2806 in combination with cabozantinib has been selected for oral presentation at the 2025 AACR Annual Meeting. • The research demonstrates KO-2806's potential to enhance antitumor activity of tyrosine kinase inhibitors in clear cell renal cell carcinoma tumors that progress on anti-VEGFR agents. • Kura Oncology expects to present the first clinical data from its Phase 1 FIT-001 trial evaluating KO-2806 as monotherapy and in combination with cabozantinib for renal cell carcinoma in the second half of 2025.

Global Diabetic Retinopathy Clinical Trials Landscape Analysis Reveals Key Research Trends for 2024

4 months ago

• A comprehensive analysis of global diabetic retinopathy clinical trials has been released, offering insights into trial distribution across G7 and E7 countries and various research phases. • The report highlights significant trends in trial enrollment patterns over the past five years, providing valuable data for healthcare stakeholders and pharmaceutical companies. • The analysis covers detailed assessment of trial statuses, sponsor types, and endpoint evaluations, helping identify key opportunities and challenges in diabetic retinopathy research.

Amgen's MariTide Shows Promising Phase 2 Results in Obesity Treatment

6 months ago

• Amgen's MariTide (maridebart cafraglutide) demonstrated positive results in a Phase 2 study for obesity treatment over 52 weeks. • The study results and progress on the MariTide development program will be discussed in an upcoming webcast hosted by Amgen. • Amgen is leveraging advanced human genetics to develop innovative therapeutics for serious illnesses with high unmet medical needs.

Ziftomenib Shows Promise in AML: Kura Oncology and Kyowa Kirin Advance to Phase 3 Trials

6 months ago

• Kura Oncology and Kyowa Kirin's ziftomenib demonstrates statistically significant efficacy in Phase 2 trial for relapsed/refractory NPM1-mutant acute myeloid leukemia (AML). • The companies plan to submit a New Drug Application (NDA) to the FDA in the second quarter of 2025, seeking approval for ziftomenib in R/R NPM1-m AML. • Phase 3 trials are set to begin in the second half of 2025, evaluating ziftomenib in combination with intensive and non-intensive chemotherapy regimens for newly diagnosed AML. • FDA feedback supports potential accelerated approval pathways in both intensive and non-intensive treatment settings, based on MRD negative CR and CR endpoints.

Fasenra Receives FDA Approval for Eosinophilic Granulomatosis with Polyangiitis

8 months ago

• The FDA has approved AstraZeneca's Fasenra (benralizumab) for treating adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). • The approval was based on the Phase III MANDARA trial, which demonstrated non-inferiority to mepolizumab in achieving remission. • Fasenra showed a significant proportion of patients could taper off oral corticosteroids, offering a crucial benefit. • This approval marks Fasenra as only the second biologic approved for EGPA, providing a new treatment option for this rare disease.