Core Insights - Vor Bio announced clinical data from Stage A of a Phase 3 study in China for telitacicept, targeting IgA nephropathy (IgAN), to be presented at ASN Kidney Week 2025 [1][2] - Telitacicept achieved a primary endpoint with a 55% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) at 39 weeks compared to placebo, indicating significant efficacy [2] - RemeGen has submitted a Biologics License Application (BLA) for telitacicept in IgAN to the NMPA in China, which would mark its fifth approved indication in the country [3] Company Overview - Vor Bio is a clinical-stage biotechnology company focused on advancing telitacicept, a dual-target fusion protein, for treating autoimmune diseases [4] - Telitacicept selectively inhibits BLyS (BAFF) and APRIL, two cytokines essential for B cell survival, thereby reducing autoreactive B cells and autoantibody production [5] - The drug is already approved in China for systemic lupus erythematosus, rheumatoid arthritis, and generalized myasthenia gravis, with ongoing global Phase 3 trials for further approvals [6] Industry Context - IgA nephropathy is a leading cause of chronic kidney disease and end-stage renal disease, with up to 40% of patients progressing to ESRD within 20 years of diagnosis, highlighting the need for effective therapies [7] - Current treatments primarily slow disease progression without addressing the underlying immunopathology, indicating a significant unmet medical need [7] - The overproduction of galactose-deficient IgA1 is recognized as a central driver of IgAN, with BAFF and APRIL promoting its production [8]
Vor Bio Announces Late-Breaking Oral Presentation of China Phase 3 IgA Nephropathy Clinical Study at American Society of Nephrology's Kidney Week 2025