TPIV200 is an investigative cancer vaccine, a type of immunotherapy being developed by TapImmune for the treatment of ovarian and breast cancer.

Immunotherapies are treatments that stimulate the body’s own immune system to fight cancer. Cancer vaccines are a type of immunotherapy made from a weakened form of the disease from which they want to protect the body. When injected, these vaccines make the immune system produce antibodies and start an immune response against cancer cells.

How TPIV200 works

TPIV200 is a cancer vaccine that targets a protein called the folate receptor alpha (FRα), which is present in large amounts in several cancers cells (particularly ovarian cancer cells) and is absent in healthy cells.

When TPIV200 is injected under the skin of patients it binds to FRα present on the surface of cancer cells, inducing T-cells from the immune system to start an immune response against cancer.

TPIV200 is designed to activate specific types of T-cells called CD4+ (or “helper”) and CD8+ (or “killer”) T-cells.

TPIV200 in clinical trials

The TPIV200 vaccine is being developed through a close collaboration between TapImmune and the Mayo Clinic.

Results from an initial Phase 1 study in patients with breast and ovarian cancer showed that TPIV200 was safe and well tolerated, and produced a strong immune response in 95 percent of patients analyzed. The response continued for six months or longer after the end of the study in all patients under observation. These results were published in the Journal of Clinical Oncology.

Findings from this study led the U.S. Food and Drug Administration (FDA) to grant orphan drug status to TPIV200 as a therapy for patients with ovarian cancer.

TapImmune is now assessing TPIV200, both alone and in combination with other therapies, in three Phase 2 clinical trials.

The first study (NCT02593227) is evaluating the safety, optimal dose, and optimal schedule of TPIV200 in breast cancer patients. During the trial, which is currently recruiting participants in 12 centers across the U.S, the patient’s immune response and survival for three years will be monitored.

In a press release, the company announced that an interim analysis of this study, performed when 25 percent of the total planned number of patients were included, confirmed the safety profile of TPIV200.

The second study (NCT02764333) is evaluating TPIV200 in combination with Astra Zeneca’s immune checkpoint inhibitor Imfinzi (durvalumab) in patients with ovarian cancer that became resistant to chemotherapy. This study started in May 2016 and is being conducted by Memorial Sloan Kettering Cancer Center, where it is currently recruiting participants.

The third study (NCT02978222) started early in 2017, also in the U.S., and is investigating TPIV200 in patients with advanced ovarian cancer.


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