Anixa Biosciences has announced plans to initiate a Phase II clinical trial for its breast cancer vaccine in the neoadjuvant setting, meaning it will be administered prior to surgery. The trial aims to reduce tumor burden and prevent recurrence, potentially improving patient survival rates.
The prospective trial will evaluate the efficacy of the vaccine in combination with chemotherapy and Keytruda (pembrolizumab). This approach allows for the inclusion of a diverse patient population, covering various types of breast cancer.
The primary goals of the trial include assessing the immunological response elicited by the vaccine and comparing the clinical efficacy of standard care alone versus the combination of the vaccine and standard care. The study will also analyze breast cancer tissue to confirm the vaccine’s immunological mechanism of action.
Scheduled to commence in 2025, the trial is anticipated to span two to three years. This announcement follows the initiation of a Phase I trial at Cleveland Clinic, which was supported by a grant from the U.S. Department of Defense. Preliminary results from the Phase I trial indicated no safety concerns, with the majority of subjects demonstrating immune responses as defined by the study protocol.
"We are excited to unveil our Phase II study plan, bringing us one step closer to a potentially transformative therapy for breast cancer patients," said Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "While our Phase II trial focuses on the therapeutic market, with the data obtained in this trial, we expect to conduct additional, more informed studies for both recurrence prevention and primary prevention with partners in the future."
