What to Know About the Breast Cancer Vaccine

The earliest depiction of breast cancer dates back to 3500 BCE and while there have been plenty of advancements in detection (like AI mammography), treatment, and risk assessment — one in eight women will still be diagnosed with breast cancer in their lifetime. There is no cure for the condition and it remains the second leading cause of cancer death for women. That said, a potential vaccine offers up a glimpse of hope.

PS chatted with Amit Kumar, PhD, CEO of Anixa Biosciences, the biotechnology company developing a vaccine to cure breast cancer before it starts. It almost sounds too good to be true, right? Well, here’s what to know about the early-stage vaccine, including how it works and when it could potentially come to market.

So, How Would the Breast Cancer Vaccine Work?

The vaccine requires a series of three injections given over a one-month period. It is designed to target cells that produce a specific antigen, in this case, a lactation protein that is only appears twice in a woman’s lifetime: after childbirth (until the person stops breastfeeding) and when breast cancer arises, per Dr. Kumar.

In targeting the cells that produce this antigen via vaccination, the body will be trained to have an immune response toward the cells associated with this protein. “If you’ve properly trained your immune system by vaccination, then as those cells start arising, the immune system will destroy them and prevent those cells [from becoming] a tumor, ” Dr. Kumar explains.

Because the vaccine targets a lactation protein, it does limit those who would be eligible to take it. For example, “If you’re 25 years old and you want to have children and you want to breastfeed those children, then you wouldn’t be eligible for the vaccine,” Dr. Kumar says. To clarify, the vaccine does not impact your ability to have children, but it will impact your ability to breastfeed. If a person who’s gotten the vaccine does have a child, they wouldn’t be able breastfeed (but still could use donor milk or formula), Dr. Kumar tells PS.

What Stage Is the Vaccine in Currently?

Right now, the vaccine is in phase 1 clinical trials, meaning it’s still super early and the participant pool is very small. Right now it’s only being tested on women who have already had cancer, and more specifically triple-negative breast cancer. Why this form of cancer? Because it has the most recurrences and so they’re testing to see if these women are exhibiting an immune response, Dr. Kumar says. “Triple Negative is the most lethal form of breast cancer. It has the most recurrences, and so when we do clinical trials on triple negative, we will get data much sooner than other cancers that may not recur as frequently,” he tells PS.

In phase 1, they have tested on 25 patients, thus far. In this stage, “the primary focus is to verify that it’s safe and so far, the patients have had no adverse effects,” Dr. Kumar tells PS. The only side effect was an irritation at the sites of the injection. “There are no other side effects, no myalgias, no pain, no nausea, no abnormal lab values, no organ issues, and so forth,” Dr. Kumar says. In terms of an immune response, “75 percent of the women are having a really good, robust immune response,” Dr. Kumar says. “The other 25 are having a much more modest immune response, but we believe that the immune response, even a modest immune response, will will be successful in preventing cancer,” he tells PS.

What Hurdles Are Ahead?

There are a few pretty major hurdles that the team has to overcome before a vaccine like this comes to market. For starters, the participant pool would have to get much larger, in number and demographic. “The next pool should be roughly 800 to 1000,” Dr. Kumar says. That study will go on for three to five years, he adds.

It will also have to become way more diverse. “We have 25 women that are that have gotten the vaccine, and we’ve unfortunately not been able to recruit very diversified group of women,” Dr. Kumar says. Only three out of the 25 women are non-white — a surprise to us, considering the racial disparity that exists in breast cancer mortality among Black women. Dr. Kumar hopes that demographic will expand as the location of the trial expands. “Right now, the trial is only going on in one place, at the Cleveland Clinic, and so people who are getting this vaccine for this initial phase one are patients of the Cleveland Clinic. Eventually, when we go on to the next stage, we’ll be doing trials at multiple sites in Cleveland, New York, southern part of the US, all over the place — and hopefully we’ll be able to target or recruit women of different ethnic groups in those places,” Dr. Kumar says.

After the vaccine is approved by the FDA for those with triple negative breast cancer, the team will do what’s called “bridging studies” to provide safety and efficacy results in those with other types of breast cancer and those who have never had breast cancer.

In other words: the road ahead is a long one. But it remains an exciting. “The vision here is for us to provide this for all women, addressing all types of breast cancer,” Dr. Kumar says. “If we can do that, not only will it change the way breast cancer is viewed — but it’ll change the way cancer is viewed. Because if we can do that for breast cancer, why couldn’t we do that for all cancers?”

Alexis Jones is the senior health and fitness editor at PS. Her passions and areas of expertise include women’s health and fitness, mental health, racial and ethnic disparities in healthcare, and chronic conditions. Prior to joining PS, she was the senior editor at Health magazine. Her other bylines can be found at Women’s Health, Prevention, Marie Claire, and more.