Summary of AnaptysBio Investor Event on ANB033 Company Overview - **Company**: AnaptysBio (NasdaqGS:ANAB) - **Focus**: Development of ANB033, a CD123 antagonist for autoimmune and inflammatory diseases, particularly celiac disease and eosinophilic esophagitis (EoE) [2][3][61] Key Points on ANB033 and Its Development - **Separation of Operations**: In 2026, AnaptysBio plans to separate its biopharma operations from its royalty assets to create two independent publicly traded companies [2] - **Clinical Trials**: - A Phase 1b trial for celiac disease has been initiated, with plans for a second indication trial in 2026 [3][26] - The trial design includes two cohorts: one for patients with minimal mucosal damage and another for those with significant damage [55][56] Mechanism of Action - **Targeting CD123**: ANB033 is designed to inhibit IL-15 and IL-2 signaling pathways, which are crucial in the activation and proliferation of pathogenic immune cells [4][12][20] - **Therapeutic Potential**: The drug has broad therapeutic potential across various areas, including gastrointestinal and dermatological diseases [5][26] Market Opportunity - **Celiac Disease**: - Approximately 2 million celiac patients in the U.S., with a projected 250,000 diagnosed non-responsive patients by early 2030s [8][61] - The market for celiac disease treatments is estimated to exceed $4 billion, with no approved therapies currently available [8][62] - **EoE Market**: - EoE is characterized by inflammation of the esophagus, with limited treatment options available [63] - Dupilumab, the only approved therapy, is expected to generate $2 billion in sales by 2025, indicating a significant market opportunity for ANB033 [63] Clinical Data and Safety Profile - **Phase 1a Trial Results**: - ANB033 demonstrated a favorable safety profile with no severe adverse events reported [36] - The drug maintained full receptor occupancy for over 30 days, with a dose-response observed on relevant pharmacodynamic biomarkers [36] - **Impact on Immune Cells**: - ANB033 significantly reduced CD123 expressing CD8 T cells and NK cells without compromising overall immune competency [37][39] Unmet Medical Need - **Celiac Disease Treatment**: Current treatment options are limited to a gluten-free diet, which is often poorly tolerated [41][62] - **Patient Population**: Many patients continue to suffer from symptoms such as anemia and fatigue despite adherence to a gluten-free diet [41][62] Future Directions - **Additional Indications**: AnaptysBio is exploring other potential indications for ANB033, including EoE, with plans to advance one additional proof of concept trial in 2026 [26][61] - **Regulatory Engagement**: The FDA has shown enthusiasm for new treatments for celiac disease, emphasizing the need for therapies that can prevent symptoms and improve histological injury [51] Conclusion - **Strategic Positioning**: AnaptysBio is well-positioned to address significant unmet needs in the treatment of celiac disease and EoE with ANB033, leveraging its unique mechanism of action and favorable safety profile to capture a substantial market opportunity [62][63]