Obexelimab

FDA Approves First Targeted Therapy for IgG4-Related Disease: Amgen's UPLIZNA

10 days ago

• The FDA has approved Amgen's UPLIZNA (inebilizumab-cdon) as the first and only targeted treatment specifically for IgG4-related disease, following positive results from the Phase III MITIGATE trial. • The MITIGATE trial demonstrated an 87% reduction in disease flare risk compared to placebo, with the study enrolling 135 adults across 80 sites in 22 countries. • Multiple companies including Sanofi and Zenas BioPharma are advancing a robust pipeline of approximately 10 therapies for IgG4-related disease, potentially transforming treatment options for this rare inflammatory condition.

UPLIZNA Becomes First FDA-Approved Treatment for IgG4-Related Disease, Reducing Flare Risk by 87%

2 months ago

• The FDA has approved UPLIZNA (inebilizumab-cdon) as the first and only treatment for adults with IgG4-related disease, a chronic immune-mediated inflammatory condition that can cause permanent organ damage. • In the pivotal MITIGATE trial, UPLIZNA demonstrated an 87% reduction in flare risk compared to placebo and allowed nearly 60% of patients to achieve corticosteroid-free, flare-free complete remission. • The approval marks Amgen's expanding leadership in CD19-directed B-cell depletion therapies across multiple autoimmune diseases, including NMOSD, IgG4-RD, and potentially generalized myasthenia gravis.

Xenon Pharmaceuticals Advances Azetukalner Program for Epilepsy and MDD

6 months ago

• Xenon Pharmaceuticals is progressing its Phase 3 epilepsy program with azetukalner, anticipating topline data from the X-TOLE2 study in the second half of 2025. • The company plans to initiate the X-NOVA2 Phase 3 trial for azetukalner in major depressive disorder (MDD) by the end of the year, expanding its therapeutic focus. • Xenon is expanding its ion channel portfolio, with multiple candidates advancing towards IND filings in 2025, targeting Kv7, Nav1.7, and Nav1.1. • Long-term data from the X-TOLE open-label extension study of azetukalner in focal onset seizures will be presented at the American Epilepsy Society (AES) annual meeting.

Zenas BioPharma Completes Enrollment in Phase 3 IgG4-RD Trial of Obexelimab

6 months ago

• Zenas BioPharma has completed targeted enrollment for its Phase 3 INDIGO trial evaluating obexelimab in patients with Immunoglobulin G4-Related Disease (IgG4-RD). • The INDIGO trial is the largest clinical trial ever conducted for IgG4-RD, a chronic fibro-inflammatory disease affecting multiple organ systems. • Topline results from the Phase 3 INDIGO trial are expected to be reported by the end of 2025, marking a key milestone for Zenas BioPharma. • Obexelimab, a bifunctional monoclonal antibody, aims to inhibit B cell activity without depletion, offering a novel approach to treating IgG4-RD.

Bicara, Zenas, and MBX Bio Launch IPOs, Raising $703M for Clinical Trials

8 months ago

• Bicara Therapeutics raised $315 million to fund a pivotal trial of ficerafusp alfa for head and neck squamous cell carcinoma (HNSCC). • Zenas Biopharma secured $225 million to advance obexelimab, a bifunctional antibody, through Phase 3 trials for IgG4-related disease and Phase 2 trials for multiple sclerosis, lupus, and wAIHA. • MBX Biosciences garnered $163 million to support clinical trials of MBX 2109 for chronic hypoparathyroidism and MBX 1416 for post-bariatric hypoglycemia.

Obexelimab Shows Promise in Treating IgG4-Related Disease

2 years ago

A phase 2 pilot trial evaluating obexelimab, a novel monoclonal antibody, demonstrated significant clinical improvement in patients with IgG4-related disease, suggesting its potential as a treatment option without the need for prolonged B-cell depletion.