At age 41, Jennifer Davis began fighting the deadliest type of breast cancer: triple negative.
The married mother of three and nurse went through a double mastectomy, chemotherapy, and radiation, but knew the risk of her cancer returning.
"Triple negative has a high recurrence rate," Jennifer said in an interview with 3News back in April 2023. "Prognosis is not the greatest if it does recur, so I desperately wanted something, to be part of something that would put my mind at ease."
That chance came in fall 2021, when she became the first recipient of the experimental breast cancer vaccine at Cleveland Clinic. Ten years before Jennifer's first dose, auto repair shop owners Leigh Anne Best of Mighty Auto Pro and Laura Frank of Auto Repair Technology started Brakes for Breasts to fund the breast cancer vaccine research.
An October campaign provides free brake pads, with 10% of the bill for labor and other additional costs going to the fund. What started at five shops in Ohio spread to hundreds of other independent auto shops across the country.
"Oh my goodness, since 2011, those little 10s and 20s have added up to a little over $1.8 million," Leigh Anne said, "and we definitely will without doubt cross the $2 million mark this year."
Each year, they made check presentations to the Breast Cancer vaccine fund at Cleveland Clinic, but two years ago, they finally met Jennifer.
"She was the person that we were working for all these years," Laura told us, "and to have this person be real, I don’t know that I thought I would ever live to see the real person."
"It was a natural connection it was like we had been friends forever," Leigh Anne remembered.
And like friends, they stayed in touch. As the first recipient, Jennifer received the lowest dose of the vaccine. Her participation measured safety, dosage, and immune response.
"The vaccine has now taught my body to recognize cancer cells," Jennifer said last year when she learned she did have an immune response to the vaccine.
"We are getting an immune response in the majority of patients," Dr. G. Thomas Budd, an oncologist at the Cleveland Clinic Cancer Institute and the trial’s lead investigator, noted. "It's not 100%; nothing is 100%."
While Jennifer always knew risk of recurrence remained, the results gave her hope. She stopped thinking about the end of her life and started living the days she had left.
Then, on Jan. 31 of this year, those close to her started receiving devastating phone calls.
"I get a call from Jenni and she just said, 'Leigh Anne, it’s back. The cancer’s back,'" Best recalled, fighting back tears.
Jennifer worried about her kids and family, but she had a very important message for her friends.
"She said, 'I had the lowest dose. Do not let this stop your efforts. There are so many women out there that we need to save," Leigh Anne said. "Even in that dark moment, she was all about, 'You guys just keep up the good work. Let's see what we can do to move forward and get this vaccine out there.'"
Laura knew Jennifer would want people to understand that it took 20 years just to get the vaccine into human trials. She was the very first step, and the research must continue just so others would have a chance.
While Jennifer had renewed hope, she always knew this phase of the clinical trial was just the very beginning.
"I think she was meant to receive that first dose," Laura said, "because she was so strong, she was so positive and she so much believed that that there was something else out there."
Jennifer Davis died on April 13, 2024. Brakes for Breasts presented more than $200,000 to the vaccine research fund on the day she was laid to rest.
So far, 27 women received the breast cancer vaccine, and the clinical trial is getting ready to begin its second phase. Results are promising, but years of more research is required.
Still, had it not been for women like Jennifer, hope would take much longer.
"Thanks to very brave women who went on this trial as well as other trials that allow treatments to be developed for the benefit of others in future generations," Budd said.
Anixa Biosciences Inc., a biotechnology company focused on the treatment and prevention of cancer, now owns the vaccine. This week, they announced the plan for a phase 2 study to evaluate the efficacy of the vaccine administered in the neoadjuvant (before surgery) setting, in combination with chemotherapy and Keytruda (pembrolizumab).
The goal of neoadjuvant therapy is to reduce tumor burden and prevent tumor recurrence, with the intent to improve survival. This clinical trial approach allows Anixa to enroll a broader range of patients, encompassing multiple types of breast cancer.
The key objectives of the trial include evaluating the immunological response to the vaccine and comparing clinical efficacy of standard of care therapy alone with the vaccine plus standard of care therapy. A key component of this trial will be the evaluation of breast cancer tissue and the validation of the immunological mechanism of action of the vaccine.
The trial is expected to start in 2025, and should last two to three years.
Initial phase 1 data was presented at the San Antonio Breast Cancer Symposium last December. The data showed no safety concerns, with protocol-defined immune responses observed in a majority of patients.
Additional data from the phase 1 trial will be presented at the Society for Immunotherapy of Cancer's annual meeting in early November. The phase 1 trial was conducted in collaboration with Cleveland Clinic and is funded by a grant from the U.S. Department of Defense. Anixa is the exclusive worldwide licensee of the novel breast cancer vaccine technology developed at Cleveland Clinic.