Visterra Inc., a subsidiary of Otsuka Pharmaceutical Co. Ltd., reported positive top-line data from the ongoing Visionary phase III study of sibeprenlimab, an anti-APRIL monoclonal antibody for immunoglobulin A nephropathy (IgAN).
Clarity Pharmaceuticals Ltd. will begin early next year its pivotal phase III trial for its copper-based radiopharmaceutical, 64Cu-SAR-bisPSMA, for diagnosing prostate cancer in patients with biochemical recurrence following positive U.S. FDA feedback.
Gene and cell therapies will drive innovation for the next 10 years, Claus Zieler, the chief commercial officer at Astellas Pharma Inc., said in the newest episode of the BioWorld Insider podcast. Developers are on the cusp of breakthroughs because a gene can now be replaced “and that means we can potentially cure a disease rather than intervening in a disease.”
Innocare Pharma Ltd.’s tyrosine kinase 2 (TYK2) inhibitor, ICP-488, met the primary endpoint in a phase II trial in Chinese patients with moderate to severe plaque psoriasis, and the results clear the way to accelerate clinical development in psoriasis and other autoimmune diseases.
Gene and cell therapies will drive innovation for the next 10 years, Claus Zieler, the chief commercial officer at Astellas Pharma Inc., said in the newest episode of the BioWorld Insider podcast. Developers are on the cusp of breakthroughs because a gene can now be replaced “and that means we can potentially cure a disease rather than intervening in a disease.”
In August 2024, BioWorld tracked 92 clinical trial updates, a decrease from the 121 reported in July. The month included nine successful phase III trials, three with mixed outcomes and three failures.
South San Francisco-based Kezar Life Sciences Inc. voluntarily stopped its phase IIb Palizade trial of zetomipzomib in active lupus nephritis, following four fatal, or grade 5, serious adverse events of patients enrolled in the Philippines and Argentina.
Innovent Biologics Inc. unveiled for the first time safety and efficacy data of IBI-354, an HER2 monoclonal antibody-camptothecin derivative conjugate that shows promising efficacy signals across a range of advanced solid tumors, during the European Society of Medical Oncology (ESMO) 2024 Congress. An HER2-targeted antibody-drug conjugate developed using Innovent's topoisomerase inhibitor NT3 platform, IBI-354 combines a hydrophilic linker design with a hydrophobic payload to enhance the bystander effect, targeting adjacent antigen-low or negative tumor cells.
Ascletis Pharma Inc. is entering the obesity space, announcing it has begun two phase I trials for ASC-30, a small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist that can be dosed once monthly subcutaneously and once daily orally for treating obesity.
As Novo Nordisk A/S and Eli Lilly and Co. go head-to-head in the U.S. and Chinese glucagon-like peptide-1 receptor agonists (GLP-1RA) market for diabetes and obesity, Novo Nordisk is in innovator gear once more with leading studies of GLP-1s in Alzheimer’s disease.
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