While Imvax’s autologous immunotherapy IGV-001 missed the primary endpoint of progression-free survival in a Phase IIb trial, the company will request a meeting with the FDA to discuss next steps for “synergistic” treatment.
Despite missing the primary endpoint in a mid-stage trial, Imvax plans to take its investigational glioblastoma immunotherapy, IGV-001, to the FDA.
The Philadelphia-based biotech tested the biologic-device combo in a Phase IIb trial in 99 patients with newly diagnosed glioblastoma. In the trial arm, patients saw a median overall survival rate of 20.3 months, a six-month improvement over the placebo cohort. IGV-001 nevertheless missed the study’s primary endpoint of improving progression-free survival.
That isn’t stopping Imvax, however. The company has informed the FDA that it intends to submit a meeting request to discuss the regulatory pathway for IGV-001, according to an announcement on Tuesday.
“Paucity of treatment options is a factor” in discussions with the FDA, John Furey, executive chair of Imvax’s Board of Directors, told BioSpace prior to the announcement.
Newly diagnosed glioblastomas affect about 14,000 patients per year in the U.S., making it the most common malignant glioma in the country, according to Furey. The standard of care for 20 years has been a craniotomy, Furey said, along with the anti-cancer molecule temozolomide and radiation, with 80% of patients going this route. There have been no improvements in survival in that time, he added.
Despite the endpoint miss, Imvax is banking on the overall survival improvement, as well as the novelty of its technology, to carry IGV-001 over the regulatory finish line. IGV-001 is derived from the company’s Goldspire platform, which uses tissue removed from patients after craniotomy to create a personalized immunotherapy in the form of an antisense oligonucleotide, given back to the patient within 24 hours of the procedure.
That approach is necessary, Furey said, because glioblastoma is such a genetically heterogeneous disease that off-the-shelf, single antigen therapies will fail. Imvax hopes that IGV-001 will slip into the current standard-of-care routine, rather than replace it, especially because it takes advantage of the opening of the blood-brain barrier after craniotomy.
“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.”
