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Anixa Biosciences, Cleveland Clinic Studying if Vaccine Prevents Triple-Negative Breast Cancer Relapse

NEW YORK – Anixa Biosciences on Tuesday said it was working with Cleveland Clinic to study whether an investigational vaccine can prevent cancer from returning in patients who have been treated for early-stage triple-negative breast cancer.

Cleveland Clinic developed the vaccine, to which San Jose, California-based Anixa has worldwide exclusive rights. The vaccine is designed to activate the immune system against a-lactalbumin, a lactation protein that is not found post-lactation in normal breast tissue but is present in most triple-negative breast cancers. The vaccine also has an adjuvant that is intended to mount an innate immune response against emerging tumors and stop their growth.

The Phase I trial underway at the Cleveland Clinic has begun dosing patients with the vaccine. Researchers will enroll between 18 and 24 patients who have received treatment for early-stage disease in the last three years and are cancer free but still at high risk of relapse. Patients will receive three vaccinations, two weeks apart. The primary objective is to establish the maximum tolerated dose of the vaccine. Researchers will also monitor patients' immune response and side effects in the trial.

Anixa expects the study, which is funded by the US Department of Defense, to be completed in the third quarter of 2022. "Our vaccine has the potential to prevent the development of the most aggressive form of breast cancer — triple-negative breast cancer," Anixa President and CEO Amit Kumar said in a statement. "We look forward to the prospect of advancing this promising candidate throughout later-stage studies."

Between 12 percent and 15 percent of breast cancers are triple-negative, meaning they don't have estrogen or progesterone receptors and don't overexpress the HER2 protein. Triple-negative breast cancer patients have a higher mortality and recurrence rate compared to those with other breast cancer subtypes. Up to 80 percent of women with BRCA1 mutation-positive breast cancers are also triple-negative.

In addition to the study underway for triple-negative breast cancer, Anixa also has a vaccine trial in preclinical studies in ovarian cancer. The company ultimately has ambitions to explore the ability of the vaccine to prevent breast cancer in healthy individuals at high risk of breast cancer, either due to a strong family history of the disease or inherited pathogenic variants in genes such as BRCA1 or BRCA2, who have decided to undergo bilateral mastectomy to reduce their risk.