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June 22, 2024

IGV-001 Granted Fast Track Designation

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Imvax, Inc. announced the completion of enrollment in its randomized, multicenter, double-blind, placebo-controlled Phase 2b clinical 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) and top-line data is expected by mid-2025.

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Separately, Imvax announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IGV-001 for the treatment of ndGBM based on the company’s existing Phase 1b data supporting its therapeutic potential in this underserved and life-threatening condition.

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“We are very pleased to announce full enrollment of the trial in less than 14 months, which speaks to both the clinical interest in this potential therapy and the efficient execution of our novel approach to treating GBM patients,” said John P. Furey, Imvax's Chief Executive Officer. “We are grateful to the investigators, patients, and their families for their commitment to this study and look forward to seeing top-line data next year. 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 8-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.”


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