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.
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.
In 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.