Imvax has received $29m in a financing round from current investors, aimed at advancing the Phase IIb trial of its autologous biologic-device combination product, IGV-001, in individuals with newly diagnosed glioblastoma (ndGBM).
This funding round brings the company's total fundraising over the previous 21 months to $86m.
The randomised, multi-centre, placebo-controlled, double-blind trial is structured to evaluate the efficacy and safety of the therapy.
Nearly 100 subjects were enrolled across 20 sites in the US, with the primary endpoint being progression-free survival (PFS).
Subjects in the IGV-001 arm received biodiffusion chambers containing personalised tumour cells combined with an antisense oligonucleotide while the placebo arm received chambers with an inactive solution 48 hours post-surgical resection.
Following the explantation of the chambers, all subjects underwent standard of care after six weeks. Key secondary endpoints of the trial include overall survival (OS) and safety.
Imvax CEO John Furey said: “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.
“The financing provides us with operating flexibility well beyond the readout of the top-line results of our Phase IIb trial, which we remain on track to report in mid-2025.”
Previous Phase I trials indicated that the therapy was safe and well tolerated. A Phase Ib study also suggested efficacy, with significant improvements in OS, PFS, radiographic evidence of tumour response, and biomarker changes indicative of an immune response.
In a high-dose cohort of ten Stupp-eligible ndGBM subjects treated with the therapy, the median PFS reached 17.1 months, surpassing the 6.5 months observed with historical standard-of-care treatments.
Considered the most aggressive and common form of brain cancer, approximately 14,000 people suffer from glioblastoma in the US each year.
In May 2024, the company concluded participant enrolment for the Phase IIb trial of IGV-001 to treat ndGBM.
