California-based biotechnology company Anixa Biosciences Inc (NASDAQ: ANIX) announced on Tuesday its plan for a Phase 2 study of its breast cancer vaccine.
The Phase 1 trial is being carried out at Cleveland Clinic, funded by a grant from the US Department of Defense.
Anixa's planned Phase 2 trial is intended to assess the efficacy of the vaccine administered in the neoadjuvant (before surgery) setting, along with chemotherapy and Keytruda (pembrolizumab). Neoadjuvant therapy aims to reduce tumour burden and prevent tumour recurrence with the aim of improving survival. Key objectives of the trial include evaluating the immunological response to the vaccine and comparing clinical efficacy of standard of care therapy alone with the vaccine plus standard of care therapy. A key component of this trial will be the evaluation of breast cancer tissue and the validation of the immunological mechanism of action of the vaccine.
Expected to start in 2025, the trial is projected to last around two to three years.
Anixa is the exclusive global licensee of the novel breast cancer vaccine technology developed at Cleveland Clinic.
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