Swiss / German biotech company VAXIMM has successfully treated the first patient in its Phase I clinical trial of VXM01 to address recurrence of glioblastoma (brain tumour).
VXM01 is an oral T-cell immunotherapy targeting tumour-specific vasculature and certain immune-suppressive cells.
It features a live attenuated, safe, orally-available, bacterial vaccine strain, which is modified to carry vascular endothelium growth factor receptor-2 (VEGFR2) as the target gene.
Heidelberg University Hospital neurology department chairman Andreas Unterberg said: “I am pleased that the first patient in this study has undergone a successful reoperation.
“Given the deadly nature of glioblastoma, we are in urgent need of treatments that will help prevent the recurrence of disease.
“Vaccination with the oral immunotherapy VXM01 has the potential to be a potent tool in helping to slow or stop the recurrence of the cancer, and I look forward to seeing the results from this study.”
VXM01 stimulates the patient’s immune system to trigger VEGFR2-specific, cytotoxic T-cells (so-called killer cells) which actively destroy cells in the tumour vasculature allowing the passage of the immune cells into the tumour.
The trial will involve patients who experienced a recurrence of disease following a prior treatment such as radiochemotherapy with temozolomide, and who can undergo routine reoperation with a safe option for delaying surgery for four to five weeks.
During the trial, patients will be orally administered with four doses of VXM01 four to five weeks before surgery and two safety magnetic resonance images at three and one week before a reoperation.
After the surgery, they may be administered with VXM01 every four weeks up to week 48.
The trial is primarily focused in determining the safety and tolerability of VXM01 while assessing its pharmacodynamic provide and clinical response.
It will also particularly focus on determining the VXM01-related cytotoxic T-cell response, measuring immune cell infiltration and detecting changes in the vascularisation and the PD-1 / PD-L1 status of the tumour.
Image: MRI scan displaying glioblastoma. Photo: courtesy of Christaras A via Wikipedia.