On November 20, 2023 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, reported details of its two poster presentations at the 2023 Society for NeuroOncology (SNO) 28th Annual Meeting, which was held in Vancouver, British Columbia, Canada, from November 15-19, 2023 (Press release, Imvax, NOV 20, 2023, View Source;utm_medium=rss&utm_campaign=imvax-presents-new-data-at-2023-sno-annual-meeting-supporting-its-lead-program-igv-001-in-newly-diagnosed-glioblastoma [SID1234637836]).
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At the meeting, Imvax presented new data from its Phase 1b study of IGV-001 in patients with newly diagnosed glioblastoma (ndGBM) and Ian Y. Lee, M.D., Neurosurgeon, Henry Ford Health System, presented information relating to the company’s ongoing randomized, multicenter, double-blind, placebo-controlled Phase 2b clinical trial of IGV-001 in patients with ndGBM.
"These presentations highlight the importance of the Phase 1b results to the IGV-001 program and reflect the rigor of the design of the ongoing Phase 2b trial," said David W. Andrews, M.D., Chief Medical Officer of Imvax. "I’m pleased to report that the Phase 2b study is enrolling well, and we expect to complete enrollment in the first half of 2024."
The first poster presentation, entitled "Additional results from a Phase 1b study of IGV-001 in patients with newly diagnosed glioblastoma", highlights a statistically significant correlation in Imvax’s Phase 1b study of IGV-001 between progression free survival (PFS) and overall survival (OS) in the intent-to-treat (ITT) study population, suggesting the use of median PFS as an end point in future ndGBM clinical trials. Additional data presented highlighted a significant decrease in the average neutrophil-to-lymphocyte (NLR) ratio at various study points. The NLR may be a potential marker of good outcomes, which will be further explored as part of Imvax’s ongoing Phase 2b study in ndGBM patients.
The second poster presentation, entitled "A randomized, multicenter, double-blind, Phase 2b study of IGV-001, an autologous cell immunotherapy with antisense oligo IMV-001 targeting IGF-1R, vs placebo, in newly diagnosed glioblastoma patients", described the ongoing Phase 2b trial (NCT04485949) including study objectives, design, endpoints, locations, and key inclusion and exclusion criteria.
About IGV-001
IGV-001 is an autologous biologic-device combination product derived from Imvax’s proprietary Goldspire immuno-oncology platform for solid tumors, which involves a unique approach to inducing a broad and durable immune response against tumors. Phase 1 studies showed that IGV-001 was safe and well tolerated, and a Phase 1b ndGBM study also yielded several efficacy signals, including significant improvements in PFS, OS, radiographic evidence of tumor response, and multiple biomarker changes that supported the presence of an immune response (Andrews DW, et al., Clin Cancer Res. 2021;27(7):1912-1922). In ten Stupp-eligible ndGBM patients in the highest dose cohort treated with IGV-001, median PFS was 17.1 months, compared with 6.5 months in historical standard-of-care (SOC) treatment, and median OS was 38.2 months, compared with 16.2 months in historical SOC.