Imvax has announced plans to advance its investigational glioblastoma immunotherapy, IGV-001, toward regulatory review by the U.S. Food and Drug Administration (FDA), despite not meeting the primary endpoint in a Phase IIb clinical trial.
The Philadelphia-based company evaluated IGV-001—a biologic-device combination—in 99 patients newly diagnosed with glioblastoma. The treatment group experienced a median overall survival of 20.3 months, which is six months longer than the placebo group. However, IGV-001 did not achieve the study’s main goal of improving progression-free survival.
John Furey, executive chair of Imvax’s Board of Directors, said the company has notified the FDA about its intention to request a meeting regarding IGV-001’s regulatory pathway. He explained that limited treatment options play a role in discussions with regulators: “Paucity of treatment options is a factor” in discussions with the FDA.
According to Furey, approximately 14,000 people in the United States are diagnosed with glioblastoma each year, making it the most common malignant glioma nationally. For two decades, standard care has included craniotomy surgery along with temozolomide and radiation therapy; about 80% of patients follow this approach. There have been no improvements in patient survival during that period.
Imvax aims to rely on the observed increase in overall survival and its novel technology as it seeks approval for IGV-001. The therapy uses tissue collected from patients during craniotomy to create a personalized antisense oligonucleotide immunotherapy administered within 24 hours post-surgery.
Furey stated that this method is necessary because glioblastoma is highly genetically diverse and less likely to respond to generic treatments: off-the-shelf therapies targeting single antigens are expected to be ineffective. Imvax envisions integrating IGV-001 into existing care routines rather than replacing them—especially since it leverages temporary opening of the blood-brain barrier following surgery.
“What’s beautiful about this is that the blood-brain barrier is typically closed,” Furey said, but immediately following craniotomy, it’s open for a few weeks. Patients are usually in hospital for five days after craniotomy, during which time they can get IGV-001 treatment, then return in a few weeks for temozolomide and radiation. “This is totally synergistic with standard of care.”
