Regeneron(US:REGN)2023-12-14 18:56Regeneron Pharmaceuticals Inc. ASH 2023 Investor Conference Call Summary Company Overview - Company: Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) - Event: American Society of Hematology 2023 Investor Conference Call - Date: December 14, 2023 Key Points Industry Focus - Regeneron is focusing on becoming a leader in oncology and hematology with a robust pipeline of investigational medicines, particularly in bispecific antibodies and monoclonal antibodies [4][5][6] Clinical Pipeline and Innovations - The company has 10 programs in clinical development within hematology, with one approved product [7][8] - Recent advancements include: - Linvoseltamab for multiple myeloma, showing a 71% objective response rate and 46% complete response rate in patients [15][16] - Odronextamab for lymphoma, with an 81% overall response rate in follicular lymphoma and 52% in diffuse large B-cell lymphoma [19][20] - A C5 program combining an antibody with siRNA, showing promising results in controlling hemolysis in PNH patients [26][27] Combination Therapies - A novel combination approach using Dupixent and linvoseltamab aims to potentially cure severe allergies by targeting IgE-producing plasma cells [10][11][12][58] - The combination is expected to eliminate IgE cells and prevent their reconstitution, addressing a significant unmet medical need in allergy treatment [13][58] Regulatory and Development Plans - Linvoseltamab is set for a BLA filing by the end of December 2023, with a MAA submission planned for the first half of 2024 [14][17] - Odronextamab has a PDUFA date of March 31, 2024, with ongoing studies in earlier lines of therapy [19][25] - The C5 program is advancing towards pivotal trials in Geographic Atrophy and other complement-mediated diseases [27][30] Safety and Efficacy - Linvoseltamab demonstrated a manageable safety profile, with 46% experiencing mild cytokine release syndrome (CRS) [16][22] - Odronextamab showed a generally manageable safety profile, with no Grade 4 or 5 CRS events reported [22][23] Future Directions - Regeneron is exploring Factor XI antibodies for coagulation disorders, with plans for rapid advancement into registration trials starting in 2024 or early 2025 [31][32] - The company is also pursuing CRISPR technology for gene editing, with promising preclinical data for treating conditions like Hemophilia B [35][36] Market Positioning - Regeneron aims to establish a strong presence in the hematology-oncology market with its innovative therapies, particularly in light of the increasing prevalence of allergic diseases and hematological conditions [25][58] Conclusion - Regeneron is making significant strides in developing innovative therapies across oncology and hematology, with a focus on combination therapies and advanced clinical programs that address unmet medical needs [38][41]