TapImmune has started enrolling patients in a Phase ll clinical trial of TPIV200 vaccine to treat women with triple-negative breast cancer (TNBC) and who have completed first-line surgery, radiotherapy/chemotherapy.
The randomised, multi-centre, double-blinded, placebo-controlled trial will include 280 patients.
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Sponsored by Mayo Clinic, the trial has received $13.3m in grant from the US Department of Defence (DoD).
TapImmune president and CEO Peter Hoang said: “We believe TPIV200 and our other vaccine candidates have an important role to play within the current immuno-oncology ecosystem by potentially bridging a critical gap not currently addressed by other immunotherapies, which have shown promise in only a small number of patients.
“Unlike current approaches, TapImmune’s vaccines are designed to produce broad-based, durable T-cell responses in the vast majority of patients, which we believe are essential for improving clinical outcomes and ensuring potential regulatory and commercial success.”
Mayo Clinic Florida-based campus’ Department of Immunology professor Keith Knutson and Division of Hematology and Oncology Medicine professor Edith Perez will lead the trial.
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By GlobalDataIn addition, TapImmune and its clinical partners are examining TPIV200 in various ongoing Phase ll trials to treat ovarian and breast cancer.
A four-arm, randomised dosing trial in TNBC recently completed patient enrolment.
The trial is expected to help determine the optimal TPIV200 vaccine dose and regimen to maximise patients’ anti-tumour immune responses. Interim immunogenicity results from this trial are scheduled to be achieved by the first half of next year.
