Triple-negative breast cancer means that the three most common types of receptors known to fuel most breast cancer growth — the estrogen, progesterone, and HER-2/neu receptors — are not present on the tumor cells. This makes therapies targeting these molecules ineffective. Estrogen and progesterone are hormones, and HER-2 a protein.
How TPIV 200 works
TPIV 200 is composed of five peptide antigens, or molecules that can trigger an immune response. It is derived from a cell surface molecule called folate receptor alpha, or FRa, that is found in high levels on tumor cells.
Ninety percent of ovarian cancer cells and 80 percent of triple-negative breast cancer cells produce too much FRa, whose overproduction is associated with cancer recurrence.
TPIV 200 prompts killer T-cells to go after tumor cells with high levels of FRa.
TPIV 200 in clinical trials
A Phase 1 clinical trial (NCT01606241) evaluated TPIV 200’s safety and ability to trigger an immune response in patients with ovarian and triple negative breast cancer. Sixteen of the 22 patients mounted a robust immune response, which persisted after the vaccine therapy was completed, the trial showed.
The study also demonstrated that the therapy was safe and that patients tolerated it well. Tapimmune presented the results at the American Society of Clinical Oncology’s annual meeting in 2015 and published them in the Journal of Clinical Oncology
A Phase 2 trial (NCT02764333) is assessing the safety and effectiveness of a TPIV 200 combo’s ability to counter ovarian cancer. The study involves a combination of TPIV 200 and AstraZeneca’s cancer immuno-therapy Imfinzi (durvalumab) in 40 patients whose cancer progressed after they received platinum-based chemotherapy.
The combo proved safe in the first four U.S. patients, allowing researchers to accelerate trial enrollment.
Tapimmune is also conducting a multicenter placebo-controlled Phase 2 trial (NCT02978222) of TPIV 200 as a maintenance therapy for ovarian cancer that has the potential to become platinum-chemo-resistant. The objective is to lower the risk of the cancer returning.
Patients are receiving either TPIV 200 and the immune system stimulant Leukine (GM-CSF) or Leukine alone. Tapimmune study is recruiting participants for the trial in the state of Tennessee.
The company is testing TPIV 200 as a treatment for triple negative breast cancer in a Phase 2 trial (NCT02593227). The study is aimed at determining the safety, optimal vaccine dose, and treatment regimen that can maximize the immune response that TPIV 200 triggers in patients who are in the maintenance phase of their therapy. Those involved in the study must have had breast cancer surgery and chemotherapy, radiation, or both.
Tapimmune has enrolled 40 of the 80 patients it sought for the trial, and is continuing to recruit in 10 U.S. states. It hopes to wrap up enrollment by the end of 2017.
Orphan drug designation helps companies develop treatments for rare diseases by giving them incentives. These benefits include tax credits, exemption from FDA fees, assistance with clinical trial design, and potential market exclusivity for up to seven years if a drug is approved.
Fast track designation accelerates the FDA’s review of therapies for serious conditions with unmet medical needs.
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