US-based immuno-oncology company TapImmune has initiated its Phase II trial of cancer vaccine TPIV 200 to treat triple negative breast cancer by dosing the first patient.
Around 80 patients will be included in the randomised, open label Phase II trial, which will be conducted across eight sites.
Tapimmune chairman and CEO Dr Glynn Wilson said: "The clinical strategy for TPIV 200 is designed to examine the potential for this exciting T-cell vaccine in as many clinical settings as possible using the most cost-effective pathways.
"We are excited by the potential for this drug candidate and believe positive data from the Phase I study will be reflected in the results of our ongoing Phase II clinical investigations."
The initial Phase I trial demonstrated TPIV 200 vaccine’s safety and tolerability, while generating a long-lasting folate receptor alpha-specific T-cell response for most patients.
Triple-negative breast cancer does not express the genes for estrogen receptor (ER), progesterone receptor (PR) or Her2/neu, making it a difficult to treat disease.
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The TPIV 200 is a multi-epitope folate receptor peptide vaccine, which fights breast and ovarian cancer.
The product is composed of five peptide antigens freeze dried in a single vial, ready for injection after reconstitution and addition of granulocyte-macrophage colony-stimulating factor (GM-CSF).
Currently, TPIV 200 is being evaluated in two other Phase II trials at the Mayo Clinic and at Memorial Sloan Kettering.