Imvax has reported positive results from an ongoing Phase Ib clinical trial evaluating the safety and efficacy of IGV-001 to treat newly diagnosed glioblastoma multiforme (GBM).
IGV-001 is a first-in-class autologous vaccine currently under development and is made from patients’ tumour cells and an antisense formulation.
The trial’s primary endpoint was safety and the secondary endpoint was tumour response, while its exploratory objectives included assessment of PFS, OS and immune markers.
Imvax co-founder, chief medical officer and interim CEO David Andrews said: “Our results clearly demonstrate that this new investigational vaccine shows promise when compared to standard of care therapy as currently practiced.
“The Imvax vaccine demonstrated striking tumour regression in over one-third of trial patients that was associated with clinical improvements. We initiated the Phase 1b trial in 2015 and are pleased to report that eleven patients who participated in the trial have returned to active, vigorous lives.”
During the treatment period, 15 of 33 patients (45.5%) experienced no growth in the tumour as of 1 March.
An improvement of 7.3 months in OS and 3.5 months in PFS against SOC treatment alone was also observed in the subject treated with the highest vaccine dose.
Previous clinical research showed that one treatment with IGV-001 is capable of triggering a multi-pronged immune response, including a short-term innate immune response followed by a longer-term adaptive immune activity.
The US Food and Drug Administration and the European Medicines Agency granted orphan drug designation to IGV-001 for the treatment of malignant glioma.