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Anixa Biosciences CEO Dr. Amit Kumar told FOX Business that the company is working on a “game-changing vaccine” that could prevent the recurrence of the most aggressive form of breast cancer.

It’s already being tested on women who were diagnosed with triple-negative breast cancer. Kumar believes that the potentially life-saving vaccine could hit the market within the next five years. 

The vaccine was developed at Cleveland Clinic by the late Dr. Vincent Tuohy — who died earlier this year. Before his death, Tuohy and his team worked on the development of this vaccine for two decades, Kumar said.

“Various other types of cancer vaccines have been attempted and nothing has been successful,” Kumar told FOX Business. “The reason we believe that they failed is because of the mechanism of action that’s been utilized to try and destroy cancer cells.” 

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For the first time, Kumar believes the team may have made a breakthrough with a vaccine — administered in a series of three shots — that might be able to help more than just breast cancer patients. Eventually, he believes this vaccine could have the power to eliminate various forms of cancer.

After years of animal testing, the team received approval from the Food and Drug Administration (FDA) to begin human testing in 2021. In October 2021, Jennifer Davis was the first woman to undergo the series of shots.  

“A lot of people, physicians, doctors, scientists, nurses, people like myself and others are going to be working on this before this vaccine is approved,” Kumar said. “But the people who should really get the credit are people like Jenny and all the patients who let us as scientists try the vaccine out.” 

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The mother of three was first diagnosed with triple-negative breast cancer in the fall of 2018. She was only 41 years old. 

It was a harrowing reality and within a few weeks, she was assigned a team of doctors and nurses at Cleveland Clinic and started an aggressive chemotherapy treatment. She underwent four rounds of a “brutal chemotherapy drug” and was supposed to endure 12 more rounds of another chemotherapy drug afterward. 

However, she was forced to stop the second treatment short after suffering from neuropathy, a condition that left her unable to even button her own shirt. If she kept doing the chemotherapy, she could have ended up in a wheelchair for the rest of her life, Davis’ doctor warned. 

“In my mind, I thought the chemotherapy was what was going to save my life. So it was very difficult for me to finally stop,” she said. 

In 2019, she underwent a double mastectomy followed by 26 rounds of radiation.

Jennifer Davis

According to the American Society of Clinical Oncology, as many as 50% of patients diagnosed with early-stage triple-negative breast cancer experience a recurrence. 

“How triple-negative works is once you’re done with standard of care, then that’s it. There’s no pill or anything that I could take that would ensure that this would not come back,” Davis said.

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If it does come back, it tends to be much more aggressive and metastatic, meaning it’s moved to other parts of the body, Kumar added.

Davis was one of 16 people who were part of the trial, which is still ongoing. Data released last week revealed that all women had an immune response. 

“That means that that vaccine taught my body to identify these cancer cells and destroy them before they become a tumor,” Davis — sporting a tremendous smile — said. 

Dr. Amit Kumar

Kumar said the team of scientists plans to test a few more women as part of their phase one trial. Starting in 2024, they will initiate a double-blind study with hundreds of women, which will be split into two groups. Both groups will have the standard of care, but one group will get a series of placebo shots.

“The ratio of recurrences within those two groups will tell us how good this vaccine is, even if we can prevent half those recurrences. It’s still a game changer,” Kumar said.

Right now, the team is only testing the shots on women who have triple-negative breast cancer because of the high recurrence rate of the type of the disease. 

The goal, though, is to eventually test this vaccine on women with other types of breast cancer, Kumar said. Eventually, the team of scientists will test to see if this vaccine can address the prevention of cancer in women who’ve never had the disease. 

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Davis and Kumar, both of whom have daughters, have expressed how critical it is to have a vaccine like this for their children.

Kumar said that if the team is successful in this vaccine, “there’s no reason why we couldn’t develop similar vaccines for other types of cancers,” he said. 

Meanwhile, researchers from the University of Washington School of Medicine in Seattle published findings in the journal JAMA Oncology last year that said an experimental vaccine against breast cancer safely generated a strong immune response to a key tumor protein. The findings, published in November 2022, might be able to treat different types of breast cancer, according to the university. 

The “results should be considered preliminary, but the findings are promising enough that the vaccine will now be evaluated in a larger, randomized clinical trial,” lead author Dr. Mary “Nora” L. Disis, said in a statement when the findings were published. 

The vaccine has been licensed to Korean biopharmaceutical company Aston Sci. The company has initiated a randomized Phase II study in human growth receptor 2, or HER2, low breast cancer. The study is open and actively enrolling at multiple sites.

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