IGV-001

P2, N=93, Recruiting, Imvax | Phase classification: P2b --> P2

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.

These results support treatment with IGV-001 to induce clinically relevant ICD-driven anticancer immune responses in patients with GBM.

The lead product, IGV001, was evaluated in newly diagnosed glioblastoma (GBM) patients in a phase 1b study. Sequencing the T cell receptor Vβ CDR3 region in 8 clinical samples showed that clonal expansion in peripheral blood between 28d postIGV-001 and timepoints 90-150d positively correlated with OS (Spearman r=0.88, p<0.01). Key cytokines were found to be predictive of patient outcome via machine learning classification.

A classification model has been developed to predict long-term “good” vs. short-term “poor” outcomes of IGV-001-treated patients. In particular, we identified IL-8, IL-6 and IL-17A as key immune correlates of patient outcome as early as d14 post-treatment and sustained beyond standard of care treatment.

BDC containing saline or 1x106 IMV-001-treated tumor cells (hereon IOV-001 and IHV-001, respectively) were implanted in flanks of C57BL/6 mice and explanted 48 h later, as per glioblastoma clinical protocol. These data support the antitumor activity of this novel immunotherapeutic platform in multiple cancers beyond glioblastoma. Results suggest that efficacy is associated with a systemic immunological response, resulting in generation of Th1 antitumor cytotoxic T cells. Future studies are seeking to resolve the factors triggering good v. poor responses using phenotypic evaluation of T cell activation/exhaustion markers and Th1/Th2 cytokine production.

P2b, N=93, Not yet recruiting, Imvax | Trial primary completion date: Jun 2022 --> Jun 2023