Swiss Biotech’s Immunotherapy for Brain Cancer gets Orphan Drug Designation
The FDA will give special treatment to Vaximm’s oral T cell immunotherapy for glioma, which is particularly difficult to treat.
Vaximm focuses on the development of oral T cell immunotherapies for cancers. The FDA and European Commission have given Vaximm’s glioma candidate, VXM01, orphan designation, which aims to advance promising treatments for rare diseases. The designation will provide Vaximm with access to centralized marketing authorization in the EU, up to 10 years of market protection and fee reductions for regulatory activities. It will qualify for similar benefits in the US market.
VXM01 is an attenuated bacterial vaccine that has been modified to express vascular endothelial growth factor receptor-2 (VEGFR2), which stimulates cytotoxic (killer) T cells. These destroy cells in the vasculature feeding the tumor, allowing greater infiltration of immune cells. VEGFR2 is overexpressed in several forms of cancer, and VXMO1 is now being studied for the treatment of colorectal cancer and glioblastoma too.
Vaccines to stimulate a T cell response are a popular approach to treating a variety of cancers, with Scancell and PCI biotech hoping to take advantage of this. In the brain cancer field, Vaximm joins Oryx, a German biotech, which has developed an oncolytic virus that has passed Phase I/IIa.
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