On January 29, 2025 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, reported the closing of a $29 million financing round from existing investors (Press release, Imvax, JAN 29, 2025, View Source;utm_medium=rss&utm_campaign=imvax-announces-completion-of-29-million-financing-and-confirms-timing-for-topline-results-of-phase-2b-trial-of-igv-001-in-newly-diagnosed-glioblastoma [SID1234649925]). Over the past 21 months, the Company has raised $86 million to support the completion of its randomized, multicenter, double-blind, placebo-controlled Phase 2b trial of IGV-001 in patients with newly diagnosed glioblastoma (ndGBM). IGV-001 is derived from Imvax’s proprietary Goldspire immuno-oncology platform, which is designed to use a patient’s own tumor cells to induce a broad and durable immune response against tumors. The primary endpoint of the Phase 2b trial is progression free survival (PFS).
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"We are grateful for the support of our existing investors in this latest fundraising, which reflects their continued belief in the promise of IGV-001 for the thousands of patients facing a GBM diagnosis each year," said John P. Furey, Chief Executive Officer. "The financing provides us with operating flexibility well beyond the readout of the top-line results of our Phase 2b trial, which we remain on track to report in mid-2025."
About the Phase 2b Trial of IGV-001
The Phase 2b clinical trial is a randomized, multicenter, double-blind, placebo-controlled study (NCT04485949) designed to assess the safety and efficacy of IGV-001, an autologous biologic-device combination product, in ndGBM patients. The trial enrolled approximately 100 participants in a 2:1 randomization across 20 sites in the United States. Approximately 48 hours after surgical resection, participants in the IGV-001 arm were implanted with biodiffusion chambers containing a combination of personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001); in the placebo arm, the chambers contained an inactive solution only. In both arms, the biodiffusion chambers were explanted approximately 48 hours later, and after six weeks all patients were treated with standard of care (adjuvant radiotherapy and temozolomide followed by maintenance temozolomide). The primary endpoint of the trial is PFS, and key secondary endpoints include overall survival (OS) and safety.
About IGV-001 and Glioblastoma
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.
Glioblastoma is both the most common and most aggressive brain cancer and has resisted significant advances in treatment for decades. Approximately 14,000 people are diagnosed with glioblastoma each year in the United States and their average life expectancy 12 to 15 months. Just over 7 percent of patients survive five years after diagnosis.