Imvax Pursues FDA Review for IGV-001 Despite Phase IIb Miss

Imvax is preparing to engage the FDA on IGV-001, its drug-device combination for newly diagnosed glioblastoma, despite the Phase IIb trial missing its primary endpoint of improving progression-free survival. The company is focusing on overall survival (OS), where IGV-001 achieved a median OS of 20.3 months, a 6.3-month improvement over placebo. No serious treatment-emergent adverse events were reported, confirming a favorable safety profile.

The therapy delivers personalized, tumor-derived antisense oligonucleotides following craniotomy, targeting a disease with significant unmet need, where only 5% of patients survive beyond five years. IGV-001 has received fast track and orphan drug designations, and Imvax raised $29 million in January 2025, totaling $86 million in 21 months to support development.

In the competitive glioblastoma space, Kazia’s paxalisib showed a 3.8-month OS improvement, while AstraZeneca’s AZD1390 is being tested in the GBM AGILE trial, highlighting ongoing efforts to advance new treatment options.

08-12-2025