CLEVELAND — It's been 18 months since Jennifer Davis became the first patient to receive the lowest dose of Cleveland Clinic’s experimental breast cancer vaccine. She got the vaccine nearly five years since she was diagnosed with triple negative breast cancer.
Tuesday, Cleveland Clinic presented early results of the trial, showing all fourteen patients had an immune response no matter what dose they received.
"Even though I receive the lowest dose, I still built a response, which to me means, you know, my body will be able to identify and basically kill those cancer cells," Jennifer said.
While promising, there's still a long way to go. The phase one trial determined safety, maximum dose and monitored immune response. Future phases will determine if the immune response is enough to prevent recurrence.
“What's next for the trial is they are now in enrolling women that are positive for the BRCA gene and that have elected to have a mastectomy. So, they're going to study that tissue to see, exactly how effective that would be. And then the hope is it'll be given first to women that have been diagnosed and treated with breast cancer. And then the next phase will be women with the gene,” Jennifer explained.
These early results give Jennifer the hope she's been waiting for and a little peace of mind. More importantly she has faith.
“This has been studied for 20 years, two decades, and in the lab, this is exactly what they saw, a 100% success rate, 100% had no recurrence. So, I really don't think that you can ignore those numbers. And, and we'll get there, you know, it's going to take a little bit of time, but eventually we're going to wipe this thing out,” she said.
Anixa Biosciences, Inc., a biotechnology company, is the exclusive worldwide licensee for the Cleveland Clinic breast cancer vaccine. In a news release, the company said:
"The data presented showed that in the vaccinated women who have been tested to date, various levels of antigen-specific T cell responses were observed at all dose levels. The presentation was made by G. Thomas Budd, M.D., of Cleveland Clinic's Taussig Cancer Institute and principal investigator of the study.
"The trial is funded by a grant from the U.S. Department of Defense to Cleveland Clinic.
"The Phase 1a study is designed to evaluate the safety of the vaccine, identify the Maximum Tolerated Dose (MTD), and monitor the immune response in vaccinated women. All participants in the Phase 1a study are women who have had triple negative breast cancer (TNBC) within the last three years and have been curatively treated having undergone standard of care. At the time of vaccination, these participants are tumor-free, as determined by standard diagnostic techniques, but are at high risk of recurrence.
"'We are testing this vaccine to determine if a vaccinated patient's immune system is trained to destroy cancer cells expressing α-lactalbumin, a protein found on TNBC cancer cells and not on normal cells. To evaluate the vaccination effect, immune mediated biomarkers of T cell activation and antibody production specific against α-lactalbumin are measured. We are heartened by the data, and look forward to additional studies,' stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences.
"'We are pleased that varying degrees of antigen-specific T cell responses were observed at all dose levels tested to date, however, the Phase 1 trial is not designed to determine whether the responses are sufficient to prevent recurrence or primary tumorogenesis,' said Dr. Budd. 'We expect successive studies to determine how effective the immune responses are in preventing cancer.'"
This is not the only breast cancer being researched. Click HERE to learn about others.