Anixa Biosciences announced a strategic plan for a Phase II study of its breast cancer vaccine in September 2024. The proposed trial follows a Phase I trial at Cleveland Clinic with grant funding from the United States Department of Defence. The trial will evaluate the efficacy of the vaccine administered in combination with chemotherapy and Keytruda in the neoadjuvant setting. This means that it can enrol a broader range of patients across multiple types of breast cancer.
A unique target
Researchers at Cleveland Clinic identified a protein called alpha-lactalbumin, present only in healthy breast tissue engaged in lactating; it becomes “retired” when the person stops nursing their child and does not exist in any other cell in the body. However, it does appear in “many types” of breast cancer, including the “aggressive and deadly” Triple Negative Breast Cancer (TNBC). By developing vaccines that target alpha-lactalbumin, Anixa hopes that the immune system can destroy cancer cells and prevent tumours from forming.
Moving forward
The Phase I clinical trial in the breast cancer vaccine has produced “positive” clinical data, so a cancer vaccine discovery programme has commenced in collaboration with Cleveland Clinic. This will explore additional cancer vaccine opportunities for “intractable” cancers such as high incidence malignancies in lung, colon, and prostate.
The Phase II trial will evaluate the efficacy of a combination of the vaccine, chemotherapy, and Keytruda in a neoadjuvant setting, seeking to reduce tumour burden and prevent recurrence, with “intent to improve survival”. Trial objectives 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. It is expected to begin in 2025 and will last between two and three years.
The trial will enable Anixa to engage more patients with various types of breast cancer. This has potential to address the increasing therapeutic market for breast cancer as prevalence and screening increases drive demand for treatment. The development path for breast cancer treatment is expected to be shorter than primary prevention.
Accelerated treatment
Dr Amit Kumar, Chair and CEO of Anixa Biosciences is excited to unveil the plan, “bringing us one step closer to a potentially transformative therapy for breast cancer patients”.
“By targeting treatment rather than prevention, we can reach a broader patient population and potentially expedite the process of regulatory approval and partnerships. This trial marks a key milestone in advancing our mission to fight cancer through innovative therapies.”
As the Phase II trial will focus on the therapeutic market, data will be used for other studies for “both recurrence prevention and primary prevention with partners in the future”.
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