In the search for a cure for breast cancer, a major breakthrough has finally come.
This month, Anixa Biosciences, Inc., a biotechnology company working with the Cleveland Clinic, announced that its breast cancer vaccine has finished the first phase of clinical trials. The vaccine will now progress to the next phases of development, and if everything goes well, doctors may soon be able to prevent cancerous tumors from developing.
“The vaccine is designed to mobilize the patient’s immune system to find, recognize, and destroy breast cancer cells for primary prevention,” Amit Kumar, Ph.D, CEO of Anixa Biosciences, Inc., told Vogue. “If a patient is vaccinated and [their] immune system is trained to destroy the cancer cells when the cancer appears, the vaccinated immune system will destroy the cells before they can grow into a cell tumor.”
According to the Cleveland Clinic, the vaccine consists of three shots given two weeks apart. It targets a specific milk protein called alpha-lactalbumin, which is usually present only during breastfeeding and not in normal breast tissue afterward. However, researchers have discovered that this protein appears in about 70% of cases of triple-negative breast cancer (TNBC).
Dr. Rima Patel, an oncologist and assistant professor at Mount Sinai, hopes that the vaccine can help the immune system recognize this protein as dangerous and attack it before it can lead to cancer.
“It is designed to alert the immune system to attack a breast tumor, before it can develop or recur, and prevent it from growing,” Dr. Patel explains in a recent interview. “It has been studied in an early phase one clinical trial in 35 women who had a history of early-stage TNBC and are at high risk of recurrence, and in patients without a history of cancer but are at high risk of developing breast cancer due to a genetic predisposition or other factors. The study thus far showed that the vaccine is overall well tolerated and resulted in an immune response in most patients.”

Kumar points out that although research in mice suggests the vaccine is effective and shows promise for humans, it activates the immune system against alpha-lactalbumin and prevents breast tumors in mice. However, it is crucial to conduct tests with larger populations and control groups in the next phases to confirm its effectiveness and safety.
According to the American Cancer Society, triple-negative breast cancer (TNBC) is one of the most aggressive types of invasive breast cancer. It grows quickly and is more likely to spread by the time it is found, affecting about 14 out of every 100,000 women in the U.S. Additionally, they note that TNBC has a high chance of returning even after treatment, resulting in a five-year survival rate of around 77%, which is lower than that of other breast cancer types.
Currently, the vaccine is designed to prevent and treat TNBC, representing a significant headway in the battle against one of the most common cancers in women.
“This vaccine represents an exciting advancement and is unique in its aim to prevent TNBC, which can be more difficult to treat due to a lack of targeted treatments,” explains Patel. “We are extremely excited,” Kumar added. “If the data continues to be good, this vaccine would be game-changing.”