At R&D Day, Alpine Immune Highlights Updates On Autoimmune, Immuno-Oncology Programs

  • Alpine Immune Sciences Inc ALPN announced clinical updates from ALPN-303 and davoceticept programs. Key highlights from the announcement include:
  • ALPN-303
    • Well tolerated in healthy adults when administered intravenously or subcutaneously at doses up to 960 mg.
    • Pharmacodynamic analyses further support the feasibility of convenient subcutaneous therapeutic dosing every four weeks.
    • Initial data from the basket studies in renal, hematologic, and dermatologic autoimmune diseases are expected in 2H of 2023.
    • The company plans to conduct a phase 2 proof-of-concept study in systemic lupus erythematosus.
  • Also Read: FDA Lifts Partial Hold On Alpine Immune's Davoceticept Combo Trial In Advanced Cancer.
  • Davoceticept (ALPN-202)
    • Preliminary analyses of the NEON-2 trial of davoceticept plus pembrolizumab show a 37.8% reduction in prostate-specific antigen in castrate-resistant prostate cancer and a 25.5% reduction in tumor volume in poorly differentiated renal cell carcinoma (RCC). 
    • A third subject, with clear cell RCC, including prior primary resistance to nivolumab, achieved a durable confirmed partial response (-30%).
    • Across the NEON-1 davoceticept monotherapy and NEON-2 studies, 2/5 (40%) and 3/5 (60%) of subjects have achieved a confirmed partial response or stable disease, respectively.
  • Price Action: ALPN shares closed lower by 1.21% at $8.16 on Monday.
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