Zenas BioPharma

The company is a clinical-stage biotechnology organization focused on developing new therapies for multiple sclerosis (MS) and other autoimmune disorders. Incorporated in Delaware, it is committed to becoming a leader in the development and commercialization of transformative immunology-based treatments for patients in need.

The company’s lead immunology and inflammation (I&I) product candidate, obexelimab, is a bifunctional monoclonal antibody designed to target both CD19 and Fcγ receptor IIb (FcγRIIb), which are widely present across the B cell lineage. Obexelimab aims to inhibit the activity of cells involved in many autoimmune diseases without depleting them.

The company is developing obexelimab as a potential I&I treatment platform for several autoimmune diseases, each representing significant commercial opportunities. The first four indications include immunoglobulin G4-related disease (IgG4-RD), through an ongoing Phase 3 registration-directed trial; multiple sclerosis (MS) and systemic lupus erythematosus (SLE), through planned Phase 2, double-blind, randomized, placebo-controlled trials set to begin in Q3 2024; and warm autoimmune hemolytic anemia (wAIHA), through an ongoing Phase 2/3 trial currently in its Phase 2 open-label stage.

The company estimates that the commercial potential across these four indications is approximately $50 billion in the U.S. alone. IgG4-RD is a chronic fibro-inflammatory condition affecting various organ systems, including the pancreas, biliary tract, salivary and lacrimal glands, lungs, and kidneys. Recognized as a distinct condition only since 2003, IgG4-RD affects approximately 20,000 patients in the U.S., with similar prevalence rates globally.

MS is the most common immune-mediated, chronic inflammatory demyelinating disease of the central nervous system, affecting over two million people worldwide, including approximately one million in the U.S. The company estimates a diagnosed prevalence of around 650,000 MS patients in the U.S.

Systemic lupus erythematosus (SLE), the most common form of lupus, is a complex chronic autoimmune disease characterized by unpredictable flares in the joints, skin, kidneys, and other vital organs, leading to progressive organ damage. According to the Lupus Foundation of America, at least 1.5 million Americans are affected by lupus, with more than 16,000 new cases reported annually. Worldwide, approximately five million people suffer from some form of lupus, with 70% of those having SLE. The company estimates that approximately 245,000 people in the U.S. are diagnosed with lupus, of which about 172,000 have SLE.