CAMBRIDGE, Mass., Oct. 17, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that clinical data from Stage A of a Phase 3 study in China sponsored by Vor Bio’s collaborator RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), which evaluated telitacicept in adults with IgA neuropathy (IgAN), will be presented as a late-breaking oral presentation at American Society of Nephrology’s (ASN) Kidney Week 2025 being held Nov 5-9, 2025, in Houston, Texas.
Late-Breaking Oral Presentation Details
Abstract Title: Efficacy and Safety of Telitacicept in Patients with lgA Nephropathy: Results from Stage A of a Phase 3 Clinical Study
Session: Hight-Impact Clinical Trials - 2
Date & Time: November 8, 2025 from 10:45-11:00am CT
In August, Vor Bio announced topline results from the RemeGen-sponsored study, reporting that telitacicept achieved the primary endpoint of reducing proteinuria demonstrating a 55% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) at 39 weeks compared with placebo (p<0.0001). UPCR is an objective and globally recognized regulatory marker of disease activity in IgAN. Telitacicept demonstrated a favorable safety profile. The full results of Part A of the study will be shared at ASN.
RemeGen has submitted a Biologics License Application (BLA) to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China for IgAN, which if approved would become telitacicept’s fifth approved indication in China.
About Vor Bio
Vor Bio is a clinical-stage biotechnology company transforming the treatment of autoimmune diseases. The Company is focused on rapidly advancing telitacicept, a novel dual-target fusion protein, through Phase 3 clinical development and commercialization to address serious autoantibody-driven conditions worldwide. For more information visit www.vorbio.com.
About Telitacicept
Telitacicept is a novel, investigational recombinant fusion protein designed to treat autoimmune diseases by selectively inhibiting BLyS (BAFF) and APRIL - two cytokines essential to B cell and plasma cell survival. This dual-target mechanism reduces autoreactive B cells and autoantibody production, key drivers of autoimmune pathology. In a Phase 3 clinical trial in generalized myasthenia gravis in China, telitacicept demonstrated a placebo adjusted 4.83-point improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living scale) at 24 weeks, the primary endpoint of the trial.
Telitacicept is approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG). A global Phase 3 clinical trial in gMG is currently underway across the United States, Europe, South America, and Asia-Pacific to support potential approval in the United States, Europe, and Japan.
About IgAN Nephropathy
IgA nephropathy (IgAN) is one of the most common primary glomerular diseases worldwide and a leading cause of chronic kidney disease (CKD) and end-stage renal disease (ESRD). It is characterized by IgA-containing immune complex deposition in the kidney, leading to inflammation, proteinuria, hypertension, and progressive loss of renal function. Up to 40% of patients progress to ESRD within 20 years of diagnosis, underscoring the significant unmet need for effective therapies. Current treatment approaches, including optimized blood pressure control, renin-angiotensin system blockade, and SGLT2 inhibitors, primarily slow disease progression but do not address the underlying immunopathology.
The prevailing scientific consensus is that overproduction of galactose-deficient IgA1 (Gd-IgA1) is a central driver of IgAN. BAFF and APRIL, two cytokines critical to B-cell survival and function, promote the production of Gd-IgA1 and its pathogenic antibodies.
Media & Investor Contacts:
Carl Mauch
cmauch@vorbio.com
Sarah Spencer
investors@vorbio.com
