Vor Bio Announces Late-Breaking Poster Presentation of Phase 3 Primary Sjögren’s Disease Clinical Study at ACR Convergence 2025

Rhea-AI Summary

Vor Bio (NASDAQ:VOR) announced that clinical data from their Phase 3 study of telitacicept in primary Sjögren's disease will be presented at ACR Convergence 2025 (October 24-29, 2025) in Chicago. The study, conducted in collaboration with RemeGen Co., Ltd, will be featured as a late-breaking poster presentation.

Notably, RemeGen has already submitted a Biologics License Application (BLA) to China's National Medical Products Administration for telitacicept in primary Sjögren's disease. If approved, this will mark telitacicept's fourth approved indication in China.

BOSTON, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that clinical data from the Phase 3 study in China evaluating telitacicept in adults with primary Sjögren’s disease, a study sponsored by Vor’s collaborator RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), will be presented as a late-breaking poster presentation at ACR Convergence 2025, being held October 24-29, 2025, at McCormick Place in Chicago, Illinois.

Late-Breaking Presentation Details

Abstract Title: Efficacy and Safety of Telitacicept in Patients with Sjögren's Disease: Results from a Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Study

Session: Late-Breaking Posters

Date & Time: Tuesday, October 28^th, 10:30 AM – 12:30 PM CT

In early September, RemeGen announced the acceptance by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China of its Biologics License Application (BLA) for primary Sjögren’s disease, which will become telitacicept’s fourth 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 Sjögren’s Disease (formerly known as Sjögren’s Syndrome)
Sjögren’s disease is a chronic autoimmune condition in which overactive B cells drive inflammation, damaging moisture-producing glands and, in many cases, other organs. Hallmark symptoms include dry eyes and dry mouth, alongside fatigue, pain, and systemic complications affecting the skin, lungs, kidneys, and nervous system. About one-third of patients develop significant extraglandular involvement, and the disease carries an elevated lymphoma risk, often leading to substantial impairment in daily life.

One of the most common rheumatic autoimmune diseases, Sjögren’s remains underdiagnosed, with roughly half of cases unrecognized and women comprising the vast majority of patients. Despite its prevalence and burden, no systemic disease-modifying therapies exist; current care focuses on symptom management with incomplete relief.

Media & Investor Contacts:
Carl Mauch
cmauch@vorbio.com

Sarah Spencer
investors@vorbio.com

FAQ

When will Vor Bio present their Phase 3 telitacicept data at ACR Convergence 2025?

The late-breaking poster presentation will be held on Tuesday, October 28th, from 10:30 AM to 12:30 PM CT at McCormick Place in Chicago.

What is the status of telitacicept's regulatory approval for Sjögren's disease in China?

RemeGen has submitted a Biologics License Application (BLA) to China's NMPA, which has been accepted for review. If approved, it will be telitacicept's fourth approved indication in China.

What type of clinical trial was conducted for VOR's telitacicept in Sjögren's disease?

The study was a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating telitacicept in adults with primary Sjögren's disease.

Who is Vor Bio's collaboration partner for telitacicept in China?

Vor Bio's collaboration partner is RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), which sponsored the Phase 3 study in China.