PHILADELPHIA, PA — Imvax, Inc. has announced the completion of enrollment in its Phase 2b clinical trial of IGV-001, a novel treatment for newly diagnosed glioblastoma (ndGBM). The trial, which is randomized, multicenter, double-blind, and placebo-controlled, aims to evaluate Progression Free Survival (PFS) as its primary endpoint. Top-line data is expected by mid-2025.
IGV-001 is created from Imvax’s Goldspire™ immuno-oncology platform. This technology uses a patient’s own tumor cells to trigger a robust and lasting immune response against tumors.
In a separate announcement, the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IGV-001 for treating ndGBM. This decision is based on promising Phase 1b data, highlighting the therapy’s potential in addressing this aggressive and often fatal condition.
Imvax also revealed the successful closing of a $35 million financing round, with half of the funds coming from new investors. Over the past 15 months, the company has raised a total of $57 million to support the ongoing Phase 2b trial.
“We are very pleased to announce full enrollment of the trial in less than 14 months,” said John P. Furey, Chief Executive Officer of Imvax. “This rapid enrollment reflects the clinical interest in our therapy and the efficient execution of our approach to treating GBM patients. We are grateful to the investigators, patients, and their families for their commitment and look forward to seeing the top-line data next year.”
Furey also expressed gratitude for the FDA’s Fast Track designation. “The last significant advancement in the standard of care for GBM was nearly 20 years ago, and it only improved PFS by about eight weeks. This underscores the need for continued innovation. We believe IGV-001 has the potential to offer meaningful clinical benefits for patients with this deadly disease.”
On the recent funding, Furey added, “We are grateful for the support of both existing and new investors. Their belief in the promise of IGV-001 and their commitment to patients facing a GBM diagnosis are invaluable. We now have sufficient resources to complete the trial and carry us beyond the reporting of top-line results in mid-2025.”
Imvax’s advancements signal a promising future for glioblastoma treatment, offering hope to patients and their families while pushing the boundaries of cancer therapy.
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