LOS ANGELES, Dec. 8 (Xinhua) -- Positive results from the Phase 1 clinical trial of a breast cancer vaccine were announced by Anixa Biosciences and Cleveland Clinic, with hopes of FDA approval to distribute the vaccine to the public after Phase 2 and 3 trials are complete.
In a poster session called "Phase I Trial of alpha-lactalbumin vaccine in high-risk operable triple-negative breast cancer (TNBC) and patients at high genetic risk for TNBC," the data were presented by George Thomas Budd, a staff physician in the Taussig Cancer Center at Cleveland Clinic and the principal investigator of the study, at the 2023 San Antonio Breast Cancer Symposium this week.
This vaccine is designed to direct the immune system to destroy TNBC cancer cells through a mechanism that has never previously been utilized for cancer vaccine development.
The target of the vaccine is a protein called alpha-lactalbumin, which is produced by a woman's breast cells during lactation.
However, alpha-lactalbumin is present in the tumor body of more than 70 percent of TNBC patients, so researchers designed the vaccine by instructing the immune system to attack the tumor and keep it from growing entirely.
The phase 1 clinical trial consisted of 16 patients diagnosed with TNBC. To each patient, three vaccinations were given once every two weeks. Molecular markers of immune responses from both T-cells and B-cells were measured to evaluate the vaccination effect.
Data from the 16 patients treated to date showed that most patients developed significant T-cell responses, with a measurable but lesser magnitude of response in the remaining patients.
Dr. Amit Kumar, CEO of Anixa Biosciences, stated: "The data from our Phase 1 trial to date has exceeded our expectations. We look forward to reviewing additional data as the trial continues to completion, and we are in the planning stages of the Phase 2/3 studies of this vaccine."
Budd from Cleveland Clinic said: "Our hope is that future studies will demonstrate that the antigen-specific T-cell responses we observed translate to the prevention of breast cancer recurrence." ■