AACR Congress 2022: A multicenter phase 1a/b study of NG-350A, a tumor-selective anti-CD40-antibody expressing adenoviral vector, and pembrolizumab in patients with metastatic or advanced epithelial tumors (FORTIFY)

NG‐350A is a novel transgene-armed vector that selectively replicates in tumor cells and expresses an agonistic anti-CD40 antibody
In a phase 1 trial, IV NG‐350A drove sustained and dose-dependent cytokine responses consistent with the activity of CD40 agonists, without evidence of CD40-mediated toxicity

  • These data provided initial evidence that NG-350A can drive local immunological tumor changes while avoiding systemic toxicity

Given the complementary MoA of NG-350A and pembrolizumab we designed a study to further assess the safety, tolerability and preliminary efficacy of combination therapy
The FORTIFY study will assess NG-350A plus pembrolizumab for advanced cancers that have previously been treated with an anti–PD-1/L1 agent

  • Co-primary objectives are to assess safety and tolerability and to determine a recommended dose
  • Anti-tumor activity and pharmacodynamic effects of NG-350A on tumor re-programming will be assessed

View AACR 2022 FORTIFY Poster Here