Alpine Immune Sciences Stops Davoceticept Trials In Cancer Indications After Second Patient Death

  • Alpine Immune Sciences Inc ALPN has voluntarily terminated enrollment in both clinical studies involving davoceticept (ALPN-202), an investigational CD28 costimulator, and a dual checkpoint inhibitor.
  • The company has stopped enrollment in the NEON-1 study of davoceticept as monotherapy and the NEON-2 study of davoceticept in combination with pembrolizumab. 
  • Following these decisions, the company plans to focus its development resources primarily on ALPN-303 for multiple autoantibody-related inflammatory diseases and acazicolcept in development for systemic lupus erythematosus (SLE) in collaboration with AbbVie Inc ABBV.
  • The decision to terminate enrollment in the davoceticept studies was made after the company was notified of a second death in the NEON-2 study, attributed to cardiogenic shock. 
  • The participant, who had metastatic colorectal cancer previously treated with colectomy and multiple prior systemic chemotherapies, had received a single dose of davoceticept and pembrolizumab. 
  • NEON-2 had previously been subject to a partial clinical hold due to a death attributed to cardiogenic shock. 
  • The FDA removed the clinical in May after reviewing davoceticept's safety database, revised investigator brochure, and the study protocol.
  • The company is conducting an ongoing, comprehensive assessment of all NEON study participants.
  • Price Action: ALPN shares are down 7.93% at $5.28 on the last check Monday.
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