The first-ever recipient of a new breast cancer vaccine has been revealed to the public.
Ohio’s Jennifer Davis received the groundbreaking vaccine developed by Cleveland Clinic in October 2021.
She had previously battled triple-negative breast cancer and went into remission in 2018. She was chosen for the trial because there was a good chance that the cancer would return.
The shot she received is among hundreds of experimental cancer vaccines and drugs in early trials.
A cancer vaccine made by Moderna for patients recovering from advanced melanoma was given “breakthrough therapy” status by health chiefs last month, paving the way for accelerated approval.
Jennifer was diagnosed with triple-negative breast cancer during a typical workday in 2018
Ms. Davis receives the third dose of the breast cancer vaccine from research nurse coordinator Donna Lach
Ms. Davis, a nurse from Lisbon, Ohio, about 60 miles northwest of Pittsburgh, discovered a lump in her breast in February 2018.
Her first biopsy — a test done on tissue removed from a living person to check for disease — at a local hospital found no evidence of cancer.
But the nodule grew over the next few months, and Ms. Davis underwent another biopsy after an ultrasound showed abnormalities.
A week later, she was diagnosed with triple-negative breast cancer and underwent several rounds of chemotherapy and radiation, plus a double mastectomy — the removal of both breasts.
Triple-negative breast cancer makes up about 10-15 percent of all breast cancers.
It is called triple-negative because the cancer cells do not have estrogen or progesterone receptors and do not or hardly make the protein HER2.
In about 40 percent of people with stage one to three triple-negative breast cancer, the disease will return after treatment.
About 91 percent of all women with the disease are alive five years after diagnosis. However, if the cancer has spread, the five-year survival rate is 12 percent.
In general, triple-negative breast cancer has a poorer survival and cause-specific survival than non-triple-negative breast cancer.
During follow-up appointments, she learned about the breast cancer vaccine clinical trial at the Cleveland Clinic.
The shot works by targeting a lactation protein called α-lactalbumin, which is no longer present after breastfeeding in noncancerous tissues, but is present in most triple-negative breast cancers. The protein plays a key role in milk production.
If breast cancer occurs, the vaccine activates the immune system to attack the tumor and prevent it from getting bigger.
Ms. Davis is part of phase 1a of the study, which involves patients who have completed treatment for triple-negative early-stage breast cancer within the past three years.
These people must be tumor free but have a high risk of recurrence to be admitted.
She has received three doses of the vaccine, one every two weeks apart. Her last injection was in November 2021 and she has had no major side effects.
She underwent several rounds of chemotherapy and radiation, plus a double mastectomy
Jennifer with her close-knit family prior to her breast cancer treatment
Dr. George Thomas Budd, breast oncologist and principal investigator of the breast cancer vaccine trial at the Cleveland Clinic, said: ‘Triple-negative breast cancer is the form of the disease for which we have the least effective treatments.
“In the long run, we hope that this could be a real preventative vaccine that would be administered to cancer-free individuals to prevent them from developing this very aggressive disease.”
Ms Davis said: ‘There’s no medication I take to make sure there’s no recurrence.
“With every ache and pain, your mind goes to the worst-case scenario. So I was very excited when I heard about the vaccine.’
In February 2023, Cleveland Clinic entered Phase 1b of the clinical trial.
This time it focuses on cancer-free individuals who are at high risk of developing breast cancer and who have undergone a prophylactic mastectomy to reduce their risk.
Ms. Davis, now 46, is celebrating her fifth year in remission.
One of the other cancer vaccines is Moderna’s for advanced melanoma.
It works by using mRNA technology that uses bits of genetic code from patients’ tumors to teach the body to fight the cancer.
The vaccine is given to people after surgery to prevent the tumor from coming back, and it’s tailor-made for each patient, meaning no two injections will be the same.
Merck and Moderna said they plan to start a phase three trial of the therapy this year, where it will be tested on potentially thousands of patients.
They will also “rapidly spread” to other cancers, including non-small cell lung cancer.
The federal government launched a major initiative last year to reduce cancer deaths called the Cancer Moonshot.
It follows increased investment in cancer screening, prevention and treatment in recent years.