What to Know About the Breast Cancer Vaccine

If you've ever loved someone who had breast cancer, or dealt with the disease yourself, it's hard not to ask yourself the same question: Why hasn't a cure been found?

Earliest description of breast cancer dates back to 3500 BC.and although many advances have been made in the field of detection (e.g. AI mammography), treatment and risk assessment, every eighth woman will still be diagnosed breast cancer in their lives. It also remains the second leading cause of cancer death among women. But could a potential breast cancer vaccine finally offer a glimmer of hope?

We spoke with Amit Kumar, Ph.D., CEO of Anixa Biosciences, a biotech company developing a vaccine to treat breast cancer. to it begins. If it sounds too good to be true, it's fair. But an early-stage vaccine holds some promise. So we've got the details on how it works and when it could potentially hit the market.

Experts featured in this article:

What a kumarPh.D., is Chairman and CEO of Anixa Biosciences.

So how will the breast cancer vaccine work?

The vaccine requires a series of three injections over one month. According to Dr. Kumar, it is designed to target cells that produce a specific antigen, in this case a lactation protein, which appears only twice in a woman's life: after childbirth (until the person stops breastfeeding) and when breast cancer occurs.

By targeting the cells that produce this antigen through vaccination, the body will be trained to mount an immune response to the cells bound to this protein. “If you have trained your immune system properly through vaccination, then when these cells start to appear, the immune system will destroy them and prevent these cells from appearing. [from becoming] tumor,” explains Dr. Kumar.

Because the vaccine targets a lactation protein, it limits who is eligible to take it. For example: “If you are 25 years old and you want to have children and you want breastfeed these childrenIf the person who receives the vaccine has a baby, they will not be able to breastfeed (but can still use donor milk or formula), Dr. Kumar tells POPSUGAR.

What stage is the vaccine currently at?

The vaccine has officially completed its phase 1 study, so it's early but promising. In the first phase, 35 participants received the vaccine, most of whom had triple-negative breast cancer. Why this form of cancer? “Because it has the most relapses, so they are testing to see if these women show an immune response,” says Dr. Kumar. “Triple negative is the deadliest form of breast cancer. It has the highest recurrence rate, and so when we do triple negative clinical trials, we will get data much sooner than other cancers that may not recur as often,” he says.

In the first stage, the main goal is twofold: to check that it is safe, that patients have no side effects and that there is an antigen-specific immune response, Dr. Kumar tells PS. The only side effect found was irritation at the injection sites. “There are no other side effects, no myalgias, no pain, no nausea, no laboratory abnormalities, no organ problems, etc.,” says Dr. Kumar. In terms of immune response, most participants demonstrated this. “But we believe that an immune response, even a modest one, can successfully prevent cancer,” he says.

From there, the research team will collect data and prepare a report that will be sent to the FDA, as well as another report to the Department of Defense, which funded the study.

What obstacles lie ahead?

There are several hurdles the team must overcome before such a vaccine reaches the market. First, the pool of participants needs to become much larger, both in number and demographics. “The next pool should be around 800-1,000 people,” says Dr Kumar. This study will last three to five years, he adds.

It will also have to become more diverse. Few of the women in the study identified as non-white, which comes as a surprise given the racial disparities that exist in Breast cancer mortality among black women. But Dr. Kumar hopes the demographic will expand as the trial site expands. “The trial is currently only happening at one location, the Cleveland Clinic, and so the people who are getting this vaccine in the first initial phase are Cleveland Clinic patients.

Eventually, when we get to the next phase, we'll be doing trials at multiple sites in Cleveland, New York, the southern US, everywhere—and hopefully we'll be able to target or recruit women of different ethnicities in those locations,” says Dr. Kumar. The second phase of the study is expected to take at least two to three years, and the third phase three to four years.

Once the vaccine is approved by the FDA for patients with triple-negative breast cancer, the team will conduct what it calls “transitional studies” to ensure safety and effectiveness results in people with other types of breast cancer and in those who have never had breast cancer.

In other words: the road ahead is long. But it remains exciting. “We are committed to providing this care to all women, targeting all types of breast cancer,” says Dr. Kumar. “If we can do this, it will not only change the way we look at breast cancer, but it will change the way we look at cancer itself. Because if we can do the same with breast cancer, why can’t we do the same with all cancers?”

Alexis Jones (she/her) is the head of health and fitness at Popsugar, overseeing coverage on the website, social media and newsletters. With more than seven years of editorial experience, Alexis has developed a passion and knowledge in the areas of mental health, women's health and fitness, racial and ethnic health disparities, and chronic disease. Before joining PS, she was a senior editor at Health magazine. Her other original articles can be found in the magazines Women's Health, Prevention, Marie Claire and others.