NEW YORK – Imvax said Tuesday that it has raised $35 million through a financing round, which it will put toward a Phase IIb clinical trial of its autologous cell therapy, IGV-001, that is underway in glioblastoma patients.
The treatment, which relies on a platform called Goldspire, involves surgically resecting a patient's tumor, packaging the tissue from the tumor into dime-sized diffusion chambers, irradiating those chambers, and then implanting them surgically into the muscles of a patient's abdomen along with an antisense oligonucleotide. Two days later, the chambers are removed from the abdomen, and six weeks later, patients receive adjuvant radiation and temozolomide followed by maintenance temozolomide.
By implanting tissue from patients' brain tumor into their abdomen, Imvax hopes to train their lymphocytes to recognize the tumor cells in the brain, which might not be otherwise possible due to the blood-brain barrier.
In the Phase IIb trial, which is enrolling roughly 100 patients with newly diagnosed, grade III or grade IV glioblastoma, Philadelphia-based Imvax is pitting the autologous regimen against a control arm in which patients receive chambers containing a placebo followed by the same adjuvant and maintenance regimen.
The company's primary aim in this study is to assess patients' progression-free survival. Secondary endpoints in the trial are safety and overall survival.
Including the successful $35 million financing round, Imvax has raised $57 million during the past 15 months. The firm said on Tuesday that half of the recently raised capital comes from new investors and that it expects the money will fund operations beyond an expected Phase IIb data readout in mid-2025.
Imvax also announced on Tuesday that it has completed patient enrollment in this Phase IIb trial, and that the US Food and Drug Administration has granted fast-track designation to IGV-001. The designation, which allows for expedited regulatory review and more frequent interactions with the FDA, is based on data from the firm's Phase Ib trial, showing the regimen was safe and tolerable and had encouraging early efficacy.