US-based immuno-oncology specialist TapImmune has launched a phase 2 trial investigating the use of one of its immunotherapy candidates in platinum-resistant ovarian cancer. 

The company’s TPIV 200 treatment – a T-cell therapy targeting the folate receptor alpha protein – will be tested in an 80-patient, double-blind, placebo-controlled study to investigate its effectiveness in conjunction with standard of care chemotherapy.

TPIV 200 works by activating two proteins on the surface of immune system T-cells – CD4 and CD8. Both proteins are responsible for producing an effective immune response against foreign bodies.

In a phase 1 trial, the vaccine was shown to be safe and well-tolerated with 16 out of 16 patients producing robust immune responses against all five peptides found in the therapy for over six moths post-treatment.

The trial has Fast Track designation from the US Food and Drug Administration (FDA) and the drug has orphan drug status for its use in ovarian cancer.

“The opening of this study represents the fulfillment of a major 2016 milestone,” said Dr. John Bonfiglio, President and COO of TapImmune. “We now have three clinical studies utilizing TPIV 200 with approvals to enroll patients. A fourth study in triple-negative breast cancer sponsored by the Mayo clinic with a $13.3 million grant from the Department of Defense is scheduled to begin shortly. We believe the depth of these clinical programs will give us an excellent understanding of how this exciting T-cell therapy can potentially be used in the treatment of both triple-negative breast and ovarian cancers.”