FDA Lifts Partial Hold On Alpine Immune's Davoceticept Combo Trial In Advanced Cancer

  • The FDA has removed the partial clinical hold placed on Alpine Immune Sciences Inc's ALPN NEON-2 trial of davoceticept (ALPN-202) in advanced malignancies.
  • Davoceticept is a first-in-class conditional CD28 costimulator and a dual checkpoint inhibitor.
  • The partial clinical hold was prompted by Alpine's report of patient death in the NEON-2 trial. 
  • The trial is evaluating davoceticept combined with Merck & Co Inc's MRK Keytruda (pembrolizumab).
  • Related: Alpine Immune's Davoceticept Monotherapy Reduces Tumors In Early Stage Study
  • The FDA removed the hold after a review of the company's Complete Response, which included a comprehensive review of the davoceticept safety database and a revised investigator brochure and study protocol. 
  • The ongoing NEON-1 study of davoceticept as monotherapy was not subject to the hold.
  • Price Action: ALPN shares are up 2.53% at $8.51 during the premarket session on the last check Tuesday.
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