Imvax is preparing for discussions with US regulators about the next steps for IGV-001 in newly diagnosed glioblastoma (ndGBM) despite mixed outcomes from its Phase IIb trial.
During the mid-stage study (NCT04485949), the drug-device combination failed to meet its primary endpoint – offering no significant improvement to progression-free survival (PFS) over standard of care (SoC) chemoradiation alone.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Patients treated with IGV-001 in the study experienced a median overall survival of 20.3 months, representing a 6.3-month (45%) improvement over the 14.0 months seen in the placebo group. The median follow-up across the study population was 22 months.
There were no serious treatment-emergent adverse events (TEAEs) reported throughout the study, and IGV-001’s safety profile remained consistent with findings from a previous Phase Ib study.
In January 2025, Imvax secured $29m from investors to support the Phase IIb trial, bringing the company’s total funds over a 21-month period to $86m.
Despite IGV-001’s primary endpoint miss, Imvax said it aims to submit a meeting request to the US Food and Drug Administration (FDA), to facilitate discussions on a regulatory pathway for IGV-001. The FDA previously granted the therapy fast track and orphan drug designations as a glioblastoma treatment.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataAddressing the glioblastoma treatment gap
Currently, glioblastoma is an indication fraught with unmet medical needs, with around 5% of diagnosed patients surviving more than five years.
Alongside the highly aggressive nature of this cancer, no new treatment options have reached the market since the approval of temozolomide in 2005, which is currently the SoC alongside radiotherapy.
According to Imvax, IGV-001 could change this paradigm by delivering personalised, tumour-derived antisense oligonucleotides to the brain following craniotomy.
A 2025 paper published in Frontiers in Oncology highlighted the complexity of the IGV-001 protocol procedure, noting it involves a “multi-step process requiring mobilisation of multiple services within the cancer centre of a tertiary care hospital”.
Across the glioblastoma research space, Kazia Therapeutics’ paxalisib posted a Phase II/III win in the indication, offering a 3.8-month OS improvement over SoC – prompting the company to seek the drug’s FDA approval.
AstraZeneca is also aiming for a share of the market, signing a deal with the Global Coalition for Adaptive Research (CGAR), which will evaluate its biologic compound, AZD1390, in the Phase II/III GBM AGILE trial.
In oncology, Diakonos Oncology secured $20m in private funding in June 2025, which will see the biotech expedite the Phase II trial on its dendritic cell therapy, dubodencel. The study initiated dosing in July 2025.
