Anixa Biosciences, Inc. announced yesterday the initiation of a Phase 1b trial for its preventative breast cancer vaccine at the Cleveland Clinic.
This novel study, funded by a grant from the U.S. Department of Defense, has begun recruitment of healthy, cancer-free participants at high risk for developing breast cancer who have decided to undergo a voluntary bilateral mastectomy to lower their risk.
The new study is estimated to be completed by the end of 2023.
Typically, those women carry mutations in the BRCA1 or related genes and are at risk of developing triple-negative breast cancer or have a high familial risk for any form of breast cancer.
During the course of the study, participants will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response.
Anixa's breast cancer vaccine, currently in Phase 1 trials, takes advantage of endogenously produced proteins that function at certain times in life but then become "retired" and disappear from the body.
The Phase 1a study includes patients who have completed treatment for early-stage, triple-negative breast cancer within the past three years and are tumor-free but at high risk for recurrence.
One such protein is a breast-specific lactation protein, α-lactalbumin, which is no longer found post-lactation in normal, aging tissues but is present in most triple-negative breast cancers.
Activating the immune system against this "retired" protein provides preemptive immune protection against emerging breast tumors that express α-lactalbumin.
The vaccine also contains an adjuvant that activates an innate immune response, which allows the immune system to mount a response against emerging tumors to prevent them from growing.
"We are excited to commence the second stage of the Phase 1 trials for our breast cancer vaccine," stated Dr. Amit Kumar, Chairman, and CEO of Anixa, in a press release on October 26, 2022.
"While the Phase 1a trial is ongoing, the results have given us the confidence to move into this next study earlier than planned." Dr. Kumar added,
"This vaccine has the potential to prevent the development of triple-negative breast cancer, the most lethal form of breast cancer, and we look forward to advancing this promising technology through further clinical development."
This vaccine technology was invented by Dr. Vincent Tuohy, which Cleveland Clinic exclusively licensed to Anixa Biosciences.