Vor Bio Announces Late-Breaking Oral Presentation of China Phase 3 IgA Nephropathy Clinical Study at American Society of Nephrology’s Kidney Week 2025

Rhea-AI Summary

Vor Bio (Nasdaq: VOR) said clinical data from Stage A of a China Phase 3 study of telitacicept in adults with IgA nephropathy (IgAN) will be a late-breaking oral presentation at ASN Kidney Week 2025 on Nov 8, 2025 at 10:45 AM CT.

Topline results reported a 55% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) at 39 weeks versus placebo (p<0.0001) and a favorable safety profile. RemeGen has submitted a BLA to China’s CDE/NMPA for IgAN; approval would be telitacicept’s fifth indication in China.

Positive

• UPCR -55% at 39 weeks versus placebo (p<0.0001)
• Favorable safety profile reported in Stage A
• BLA submitted to China CDE/NMPA for IgAN (potential fifth indication)

Negative

• None.

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

FAQ

When will Vor Bio (VOR) present telitacicept Phase 3 Stage A data at ASN Kidney Week 2025?

Vor Bio will present on November 8, 2025 from 10:45–11:00 AM CT as a late-breaking oral presentation.

What was the primary efficacy result for telitacicept in the China Phase 3 Stage A reported by VOR?

Telitacicept achieved a 55% reduction in 24-hour UPCR at 39 weeks versus placebo (p<0.0001).

Does the Vor Bio telitacicept study report any safety concerns in Stage A?

Stage A data reported a favorable safety profile for telitacicept.

Has RemeGen filed regulatory paperwork for telitacicept in China for IgAN?

Yes, RemeGen submitted a BLA to China’s CDE/NMPA for IgAN; approval would be the fifth China indication for telitacicept.

What endpoint was used to measure telitacicept efficacy in VOR’s announced Phase 3 data?

Efficacy was measured by change in 24-hour urine protein-to-creatinine ratio (UPCR), a recognized regulatory marker in IgAN.