An experimental breast cancer vaccine showing promise in early trials raises the prospect of eliminating one of the world’s biggest killers.
So far, 15 women with an aggressive form of breast cancer have received the vaccine and have been in remission for up to five years – despite being at high risk of recurrence.
Among them is mother-of-two Jennifer Davis, a 46-year-old nurse from Lisbon, Ohio, who underwent dozens of brutal rounds of chemotherapy, radiation therapy and double mastectomy prior to her enrollment in the study.
She told that she feels better now than ever, both physically and mentally. “I can’t even imagine it. I have high hopes for everyone. “I have two daughters, I have a mother,” she added.
“I want everyone I know to have it.” I want everyone to be able to have it. If this can prevent this, it will be great.’ The new vaccine trains the body to attack a protein that is produced in pregnant and breastfeeding women but is often a precursor to cancer.
So far, it’s only been tested for triple-negative cancer, which is highly treatable if caught early. The problem is that it spreads quickly and silently to other parts of the body, and only 12 percent of patients live past the age of five.
However, there is hope that the vaccine will soon be given to healthy people years in advance to prevent them from ever developing breast cancer, making the vaccine the first of its kind.
dr Amit Kumar, CEO of Anixa Biosciences, the company developing the vaccine, told : “We could eradicate breast cancer as a disease like we eradicated polio and smallpox.”
Mrs. Davis with her daughter during her chemotherapy. She told : “I want everyone I know to get it.” [the vaccine]. I want everyone to be able to get it. If this can prevent [triple-negative breast cancer]It will be great’
Ms Davis told : “I want everyone I know to get it.” [the vaccine]. I want everyone to be able to get it. If this can prevent [triple-negative breast cancer]It will be great.’
The vaccine targets a protein called α-lactalbumin, which is only present in the body when a woman is breastfeeding or during the development of breast cancer. The vaccine trains the immune system to destroy cells that make this protein. This means that when cancer cells develop, the immune system destroys them and they never have a chance to grow into a tumor
Ms. Davis receives the third and final dose of breast cancer vaccine from Research Nurse Coordinator Donna Lach
He added, “We believe that within five years it will come to market for people like Jenni who have breast cancer and are afraid of it coming back.”
“A few years later it should be available to all women, including women who have never had breast cancer.” It’s very exciting.’
The new shot is being tested by researchers at the Cleveland Clinic in Ohio, who are more cautious but still extremely optimistic about the results.
Statistically, 40 percent of the women in the study should have their cancer return within five years, but so far none have.
dr Thaddeus Stappenbeck, Chair of Inflammation and Immunity at the Cleveland Clinic, told that the study data so far is “very encouraging”.
He said the seven-year timeline to treat all forms of breast cancer is “possible,” adding, “If all goes well and there’s a clear signal of effectiveness in the short term…that would be amazing.”
The injection is the result of more than 20 years of progress by the late Dr. Tuohy, a leading breast cancer scientist at the Cleveland Clinic Research Institute.
The vaccine – which comprises three doses two weeks apart – targets a lactation protein, α-lactalbumin, which is absent from normal, aging tissues after lactation but is present in most triple-negative breast cancers.
If breast cancer develops, the vaccine aims to trigger the immune system to attack the tumor and stop it from growing.
dr Kumar said: “If the immune system is trained properly through vaccination, when these cancer cells arise, they will be destroyed by the immune system and they will never have a chance to grow into a tumor.”
Other proteins are involved in causing more common breast cancers and other forms of the disease.
dr Stappenbeck said: “It is possible to change the protein target of the vaccine to treat other forms of cancer, as long as the protein is no longer expressed in normal healthy tissues but is expressed in the tumour.”
He said the clinic is already making progress in developing an ovarian cancer vaccine using this approach.
Ms. Davis was the first woman in the study to receive the vaccine. When she got the vaccine, she had been cancer-free for three years.
Triple-negative breast cancer accounts for about 10-15 percent of breast cancers, but is one of the most difficult to treat.
The National Cancer Institute’s (NCI) Surveillance, Epidemiology, and End Results (SEER) program shows that 13 out of every 100,000 women in the United States have triple-negative breast cancer.
The graph above shows the female breast cancer case rate per 100,000 people compared to the death rate represented by the red squares. As death rates have fallen, case numbers are still rising
The disease is called triple negative because the cancer cells do not have estrogen or progesterone receptors, nor produce the protein called HER2, or no protein at all.
This means that triple-negative breast cancer has fewer treatment options than other types of breast cancer because the cancer cells don’t have the receptors or proteins to allow hormone therapy or targeted HER2 drugs to work.
About 40 percent of people with stages 1 to 3 triple-negative breast cancer will have the disease again after treatment, usually within five years of diagnosis.
How the vaccine works
During breastfeeding, the body produces a protein called α-lactalbuminm.
Normally, as women age and stop breastfeeding, the body stops producing protein.
α-Lactalbumin is present in more than 70 percent of triple-negative breast cancers.
The vaccine activates the immune system to destroy cancer cells that produce this protein.
T cells are activated and expanded, allowing the body to attack α-lactalbumin.
When breast cancer cells that produce α-lactalbumin emerge, immune cells destroy the cells before they grow into a mature tumor.
Source: Cleveland Clinic
To be included in the study, the 15 women had to be tumor-free but at high risk of recurrence.
To date, none of them have had their cancers come back, and some, like Ms. Davis, have been in remission for nearly five years. It’s the insight that gives doctors quiet confidence that they can beat the disease.
In February 2018, Ms. Davis first discovered a lump in her breast.
She underwent a mammogram, which came up as an alert, followed by an ultrasound and a biopsy, which found no evidence of cancer.
But she continued to feel the knot growing. She said, “I knew something was wrong.”
Ms Davis had the lump biopsied again in September. This time it was revealed that she had triple negative breast cancer.
She said, “They didn’t want to miss it, but they missed it.”
Ms. Davis began chemotherapy and a double mastectomy, followed by 26 rounds of radiation. She had stage 2 triple negative breast cancer, meaning the cancer hadn’t spread to other parts of her body yet.
But the treatment had serious side effects. She lost seven pounds in three days and her fingernails and toenails fell off.
Ms. Davis went into remission in 2018. She got a second opinion at the Cleveland Clinic and began treatment there.
She learned about the vaccine, but it wasn’t in the human phase yet.
Ms Davis participated in the clinical trial and was the first person to receive three doses of the breakthrough vaccine in October and November 2021.
She said, “It was meant to be.” I had weeks to get it [the vaccine] because no more than three years may have elapsed after the first day of chemotherapy.’
Ms Davis told : “It’s literally like getting the flu shot.” “Apart from lumps at the injection site, there weren’t any side effects.”
She said: “Anyone who has had a life-threatening illness is always afraid that the illness will come back and that can affect you in terms of fatigue and your overall physical and mental health.”
“But after I got the vaccine that’s how I felt, even though I didn’t know if I had built up an immune response, only in my heart.” If you look at the data, those things just went away.
“I don’t think about a repeat every day like I used to.” I don’t think oh my god I have a headache today. do i have a brain tumor Now I just think you have a headache. “Have an aspirin and you’ll be fine.”
Jennifer Davis’ daughter Abby and son Austin support their mother before treatment (left). Austin and wife Davis during their treatment (right)
Ms. Davis (second from right) with her close family before her breast cancer treatment. She said she wanted her two daughters to get the vaccine
The vaccine uses a traditional method of administration.
dr Stappenbeck explained, “It’s a simple vaccine.” They make the protein, mix it with something called an adjuvant that stimulates the immune system, and inject it.
“It essentially behaves like a foreign protein, and your immune system recognizes this, processes it, and then, when it sees it, is primed to activate your immune system cells to attack it.”
He said, “It’s a protein vaccine.” This is a very old-fashioned technique. They make the protein in the lab, clean it, and then mix it with the vaccine. There are many very successful vaccines that use this technology.
“This is a protein that’s normally made in breast milk.” It doesn’t enter the bloodstream in large amounts.
“The protein in the vaccine is the same protein that’s made in breast milk.” But now it’s in a place where it shouldn’t be.’
Because the immune system has never seen this protein in the bloodstream, it essentially sees it as foreign and mounts an immune response to it, said Dr. Stappenbeck.
He added: “The immune response is against the protein, and so cells that make the protein and have the protein on their surface or attached to the tumor activate T cells that come in and eventually attack the tumor cells that are moving are in it.’ make the protein.’
It’s essentially like a measles vaccine, said Dr. Stappenbeck, but instead of attacking a pathogen, it is a protein.
dr Kumar said: “The ideal situation would be that we would vaccinate women after they have decided not to have children anymore.”
“Usually most women are by 40.” [are done]or some women will decide at an earlier age that they can finish raising children and get vaccinated earlier.”
The next test for the vaccine is a Phase 1b trial funded by the US Department of Defense.
The team will recruit a dozen women who have never had triple-negative breast cancer but are at very high risk due to genetic factors.
To reduce the risk of breast cancer, women are given a voluntary prophylactic mastectomy—the surgical removal of both breasts, even if they are perfectly healthy at the time.
The researchers will vaccinate the women before their surgeries.
dr Kumar said: “After the surgeries, we will have a huge amount of resected breast tissue to see if the immune cells we generated from the vaccination are monitoring the breast tissue like we saw in the animal studies.”
The researchers expect this phase to be completed by the end of the year.
But the vaccine will have other hurdles to overcome.
Researchers will recruit several hundred women and seek to enroll women from diverse ethnic backgrounds in the Phase 2 element of the study.
You will also look at safety and assess some additional indicators of effectiveness.
Phase 3 will be the large, multi-center, multinational study that will test thousands of women “to make sure we haven’t missed anything in certain types of women for safety reasons,” said Dr. kumar
Amit Kumar, CEO of Anixa Biosciences (left), the company developing the vaccine. He said, “It would be fantastic to give it to practically every woman in the world who is concerned about breast cancer.” Thaddeus Stappenbeck (right), Chair of Inflammation and Immunity at the Cleveland Clinic, told , “This is essentially like a measles vaccine.” Instead of being a pathogen, it’s a protein.
The study is a double-blind, placebo-controlled experiment in which neither the women in the study nor the doctors administering the vaccine know which women are receiving the placebo control and which are receiving the vaccine.
dr Kumar said: “Then we will monitor how many women in the placebo group get cancer and how many women in the vaccinated group get cancer.”
“We hope and expect that no or a very small number of women in the cancer group will develop cancer in the vaccine group and a larger number in the placebo group.”
He added, “We did the exact same experiment in mice.” We took mice that had been genetically engineered to develop breast cancer.
“These are mice that will automatically get breast cancer after birth if you just leave them alone.” Half of these mice were vaccinated and half had a control.”
In all animal studies, Dr. Kumar that about a thousand mice were vaccinated.
He said, “We found that 100 percent of the vaccinated mice remained cancer-free, while all of the mice that received the control group developed cancer.”
“It’s a kind of experiment that you don’t see in biology because you rarely get a 100 percent response in biology.” “We’d like to see a 100 percent response in humans, too.”
dr Kumar pointed out that because the mice are in the same type of cage and fed the same diet, fewer variables will affect the mice, whereas the females are all different.
He said: “But even if we get 80, 90 percent [in future human trials]”It’s still spectacular.”
dr Kumar has high hopes for the future. He said: “Let’s say we go through all the clinical trials; everything looks great. One day it would be fantastic to give it to practically every woman in the world who is afraid of breast cancer.
“Assuming we have approvals in the US, Europe and various other jurisdictions, potentially every woman in the world would be a candidate.”