Ctim-17. additional results from a phase 1b study of igv-001 in patients with newly diagnosed glioblastoma

Abstract Imvax has developed the Goldspire™ platform to create IGV-001, an autologous biologic-device combination product for the treatment of newly diagnosed glioblastoma (ndGBM). IGV-001 consists of autologous GBM tumor cells and an antisense oligonucleotide against IGF-1R mRNA (IMV-001), irradiated and administered via biodiffusion chambers implanted in the abdomen. Together, these components stimulate immunogenic cell death and antigen release. IGV-001 was well tolerated and multiple efficacy signals were observed in a Phase 1b study in patients with ndGBM (Andrews et al., 2021), including significant improvements in progression-free survival (PFS), radiographic evidence of tumor response, and changes in immune response biomarkers. A Phase 2b randomized, multicenter, double-blind, placebo-controlled study has been initiated to assess the safety and efficacy of IGV-001 in patients with ndGBM (NCT04485949). Here we report additional data from the Phase 1b study. We identified two different outcome groups in the ITT population with 14 (42.4%) patients with good outcome (OS ≥ 22.0 months) and 19 (57.6%) with poor outcome (OS < 22.0 months). We also observed a significant correlation between PFS and OS in the ITT population. Five of 33 patients (15.2%) had an OS of at least 60 months. The safety of the biodiffusion chamber implantation and explantation procedures is further supported by data from four patients that were reimplanted upon progression in the Phase 1b study. The neutrophil:lymphocyte (N:L) ratio emerged as a potential marker of good response that will be explored further in the ongoing Phase 2b study. Overall, these data support the ongoing Phase 2b randomized study designed to assess the efficacy and safety of IGV-001 in patients with ndGBM.