The study will evaluate the safety and efficacy of IGV-001 in around 100 participants with newly diagnosed glioblastoma. Credit: Lightspring / Shutterstock.

Imvax has concluded the enrolment of participants in the Phase IIb clinical trial of IGV-001 to treat patients with newly diagnosed glioblastoma (GB).

An autologous biologic-device combination product, IGV-001, utilises the patient’s tumour cells to trigger a comprehensive and long-lasting immune response against cancer.

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The multi-centre, randomised, double-blind, placebo-controlled study will evaluate the safety and efficacy of IGV-001 in around 100 participants.

Participants were assigned to a 2:1 ratio across 20 sites in the US.

Following surgical resection, patients in the trial’s IGV-001 arm received biodiffusion chambers implanted with a mix of personalised whole tumour-derived cells and an antisense oligonucleotide (IMV-001).

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Those in the placebo arm received chambers with an inactive solution.

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Progression-free survival (PFS) is the trial’s primary endpoint while overall survival (OS) and safety will be assessed as key secondary endpoints.

Top-line data from the trial is anticipated to be released by mid-2025.

In a separate development, the US Food and Drug Administration (FDA) granted fast-track designation to IGV-001 to treat ndGBM.

The decision is influenced by promising Phase Ib data that suggested significant therapeutic potential for this condition.

Imvax also secured approximately $35m in a funding round, and half of the investment came from new investors.

To support the completion of the Phase IIb trial of IGV-001, the company secured $57m over the past 15 months.

Imvax CEO John Furey said: We are also delighted that the FDA has granted fast track designation to IGV-001.

“The last significant advancement in the standard of care for GBM – about an eight-week improvement in PFS – was nearly 20 years ago, highlighting the need for continued innovation and treatment options. We believe IGV-001 may offer meaningful clinical benefit for patients diagnosed with this deadly disease.”