Imvax reported positive results from an ongoing phase I clinical trial evaluating the safety and efficacy of IGV-001 in the treatment of newly diagnosed glioblastoma multiforme (GBM).
The IGV-001 is a first-class autologous vaccine currently under development and is made from patient tumor cells and an anti-smear formulation.
The primary endpoint of the study was safety and the secondary outcome was tumor response, while its exploratory objectives included assessment of PFS, OS and immunological markers.
Co-founder of Imvax, chief medical officer and interim CEO David Andrews said: "Our results clearly demonstrate that this new experimental vaccine is promising compared to the standard treatment currently practiced.
"The Imvax vaccine demonstrated marked tumor regression in more than a third of the study patients that was associated with clinical improvements."
"The Imvax vaccine demonstrated marked tumor regression in more than a third of the study patients that was associated with clinical improvements. We started the Phase 1b test in 2015 and are pleased to report that eleven patients who participated in the test returned to active and vigorous lives. "
During the treatment period, 15 of the 33 patients (45.5%) had no growth in the tumor as of March 1.
An improvement of 7.3 months in OS and 3.5 months in PFS versus SOC treatment alone was also observed in the individual treated with the highest dose of vaccine.
Previous clinical research has shown that a treatment with IGV-001 is capable of eliciting a multifaceted immune response, including an innate short-term immune response followed by long-term adaptive immune activity.
The US Food and Drug Administration and the European Medicines Agency have granted the designation of an orphan drug for IGV-001 for the treatment of malignant glioma.