15 November 2017 - - US-based immuno-oncology company TapImmune Inc. (NASDAQ: TPIV) has completed patient enrollment in a randomized Phase 2 clinical study of its novel T-cell vaccine candidate TPIV200 for treating triple-negative breast cancer (TNBC), the company said.
The comprehensive four-arm study is designed to help determine the optimal vaccine dose and regimen to maximize the immune response generated against the vaccine's molecular target, folate receptor-alpha (FRa), a cancer cell biomarker that is highly correlated with disease recurrence.
TapImmune and its clinical partners are evaluating TPIV200 in multiple ongoing Phase 2 trials for treating ovarian and breast cancers, including a 280-patient efficacy trial sponsored by the Mayo Clinic that is randomized, double-blind, and placebo-controlled to evaluate disease-free survival in women with advanced TNBC.
TPIV200 is a peptide-based cancer vaccine that has been shown to induce "memory" T-cell immune responses directed against folate receptor alpha, a molecule that is overexpressed on the surface of the vast majority of TNBC cancer cells and is associated with cancer recurrence.
As an off-the-shelf vaccine consisting of several FRa peptides, TPIV200 is able to stimulate both "helper" T cells and "killer" T cells to target tumor cells, and the vaccine peptides are predicted to cover greater than 85% of human genotypes worldwide.
The randomized, multi-center study enrolled over 80 women with stage I (T1c)-III TNBC who have completed initial surgery and radiation/chemotherapy, and who have not yet had a cancer recurrence.
The four-arm study randomized patients to receive six monthly injections with a high dose or a low dose of TPIV 200, with or without a single treatment of cyclophosphamide prior to vaccination. Patients will continue to receive a booster vaccine every six months while they remain progression-free.
The primary endpoint of the Phase 2 study is the immune response against the vaccine target, folate receptor-alpha, as measured by the presence of anti-FRa T cells.
TapImmune develops immunotherapies for cancer, with multiple Phase 2 and Phase 1b/2 clinical studies currently ongoing for the treatment of ovarian and breast cancer.
The company's peptide- or nucleic acid-based immunotherapeutic products comprise multiple naturally processed epitopes designed to comprehensively stimulate a patient's killer T cells and helper T cells, and to restore or further augment antigen presentation by using proprietary nucleic acid-based expression systems.