CLEVELAND, Ohio — Researchers think the early results from a trial vaccine could be a breakthrough in the fight against an aggressive and deadly form of breast cancer.
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This month, Cleveland Clinic and Anixa Biosciences released positive new data from the first phase in the trial of an unnamed vaccine for triple-negative breast cancer.
According to the Centers for Disease Control, one in eight women will be affected by breast cancer in their lifetime. The Cleveland Clinic says about 15% of those cases are triple-negative breast cancer, which spreads more quickly and can be more difficult to treat than other types of cancer.
Jenni Davis recalled the feeling of dread when she was diagnosed with the disease.
“You shift how you live when you think about those things,” Davis said.
The mother of three visited her doctor after discovering a lump in her left breast. Within weeks of the diagnosis, she began chemotherapy, the first of 26 rounds of radiation and a double mastectomy.
“[There was] not a lot of time to process what was happening,” Davis said. “I have children and my mom and husband and stepdad, everybody. It was difficult.”
A team at the Cleveland Clinic successfully treated the Lisbon, Ohio native. But Davis said the progress was tempered by the thought of the cancer returning.
“It was in the front of my mind every day, every single day,” she said.
Triple-negative breast cancer (TNBC) survivors face a more than 40% chance of the disease coming back. The second occurrence is often more aggressive and difficult to treat. Davis said the statistics made it an easy decision to take part in a vaccine trial for the disease.
“I am beyond grateful that I got to be a part of this trial and I'm excited for where it's heading,” she said.
Davis was the first human participant in the study of an unnamed vaccine developed with decades of research at the Cleveland Clinic.
Sixteen patients participated in the first phase of the trial. The women, all TNBC survivors with a high risk of developing the cancer again, received three vaccinations given once every two weeks.
Researchers say the early results are encouraging.
“I’m making some very bold statements based on the results of 16 women, but the data is incredibly promising and we hope as we go forward that we will have as good or better results in larger numbers of women,” said Dr. Amit Kumar, the CEO and chairman of Anixa Biosciences.
The biotechnology company is manufacturing the vaccine in collaboration with the Cleveland Clinic. Results released by Anixa in early December show all of the trial participants experienced some immune response from the vaccine. 75% of the women had especially robust cancer-fighting immune responses.
Dr. Kumar is hopeful expanded study of the vaccine will corroborate the early findings. He believes the research and methods used for the TNBC vaccine could help advance the prevention of other diseases.
“It may take a few decades, but one day we may have vaccines for multiple types of cancers,” he said.
Trial participants, including Davis, report little to no side effects from the vaccine. Davis said it’s eased her mind and helped her focus on her family and life, rather than a potential future cancer battle.
“I look forward to everyone being able to get it, I look forward to my girls being able to get it one day,” she said. “It’s just something I am so thankful for.”
Anixa and the Cleveland Clinic are scaling up the first phase of the vaccine trial to include more participants. A second phase set to begin in mid to late 2024 will include a controlled group receiving the standard of care to compare to the group receiving the vaccine.
