The Vaccine Story
This is an exclusive interview with Dr. Vincent Tuohy at the Lerner Research Institute at the Cleveland Clinic to discussing the launch of the Phase I Trial for Triple Negative Breast Cancer, the most lethal form of the disease for which there is no adjuvant therapy. You will also hear from five women, Judy Fitzgerald. Toni Turchi, Dr. Marjorie Moyar, Laura Frank and Leigh Anne Best whose philanthropic work helped raise awareness and funds to bring this breast cancer vaccine to the clinic. Click on the picture above to listen to the story. Thanks to a lobby effort and support from Congresswoman Debbie-Wasserman Shultz, in 2019 Dr. Tuohy was awarded a six million dollar grant from the Department of Defense Breast Cancer Research Fund to develop the human vaccine and plan and intiate the Phase I Clinical Trial in women. Sadly, Dr. Tuohy passed away on January 18, 2023 but at the time of his passing, Dr. Tuohy was aware that the vaccine was creating an immune response in the women in the trial.
Phase I Breast Cancer Vaccine Poster at
San Antonio International Breast Cancer
Conference Lay Abtract Trail Results
The trial was based on Dr. Tuohy's “Retired Protein Hypothesis,” Dr. Tuohy proposed that as we age, we stop producing certain proteins that are no longer needed, such as the pigment in our hair, and the lactation protein in this vaccine called alpha-lactalbumin (aLA). This protein is normally only expressed in breast tissue during lactation. It also re-emerges in certain breast tumors, especially triple-negative breast cancer (TNBC), which we know is the most aggressive and lethal form of the disease and is among the most difficult to treat.
Laboratory studies with mice showed that vaccination against alpha-lactalbumin could delay the growth of established breast cancers and altogether prevent the production of breast cancers in some mice who had a high risk of developing breast cancer. Studies indicate that about 70% of triple-negative breast cancer (negative for estrogen-receptor, progesterone receptor, and HER2) express alpha-lactalbumin.
The goals of our Phase I clinical trial were to determine:
1. Whether we could safely deliver the alpha-lactalbumin vaccine to women who had completed treatment for operable triple negative breast cancer or who were at high risk to develop breast cancer due to genetic factors.
2. Whether vaccination could produce an immune response to alpha-lactalbumin.
What We Showed:
We studied 35 women, 26 who had completed standard therapy for high-risk triple-negative breast cancer (TNBC), 4 who carried a BRCA gene putting them at risk for breast cancer and electing to undergo preventive bilateral breast cancer, and 5 women who received pre-operative chemotherapy and pembrolizumab immunotherapy and who continued to receive pembrolizumab post-operatively during the vaccination period.
Adverse events at Dose Level 1 were generally mild and consisted primarily of lumps, itching, tenderness, or redness at the injection sites. Higher doses produced small ulcers or skin breakdown that appeared at the injection sites. These lesions healed over time, but we felt that skin breakdown would not be acceptable to healthy patients trying to prevent breast cancer. Therefore, we concluded that Dose Level 1, which produced an immune response in most patients, would be best. No other adverse events related to the vaccine were observed.
Overall, about three-quarters (74%) of patients developed the intended immune response which was determined by the number of T cells reacting specifically to alpha-lactalbumin. The T cell response was measured by the production of the inflammatory markers interferon-gamma (IFNγ) and interleukin-17 (IL-17).
Our poster illustrates that we met the major goals for the alpha-lactalbumin vaccine in Phase I by demonstrating that the vaccine was well tolerated, and effective in producing the intended immune response at Dose Level 1.
What We Did Not Show:
A Phase I trial such as this is designed only to establish the safety and optimal dose of the drug. Efficacy, or whether or not the vaccine can prevent TNBC or the recurrence of TNBC will be tested in Phase II.
The Future:
Future Phase II and Phase III studies are planned to determine if the aLA vaccine actually prevents or delays breast cancer recurrence or development. We will address further questions such as:
· Whether booster shots are needed.
· Whether some people respond better to the vaccine than others.
· Why, and when, and how this vaccine is best given.
This trial would not have been possible without the support of Congresswoman Debbie Wasserman Shultz. As depicted in the above video, the Congresswoman first brought Dr. Tuohy before Congress in 2010 to seek funding for the trial. As the result of the lobby efforts of Judy Fitzgerald, Toni Turchi and Marjorie Moyer, the Congresswoman submitted the report language they requested to the house budget, and it passed. It was modified and changed by the Senate, but the resulting funds became the NCI Prevent Program. This made the funds available for the Phase 1 trial which concluded in 2025 as depicted in the poster that was presented at the San Antonio International Breast Cancer Conference. Phase II will be conducted by Anixa BioScience and just recently the official transfer of the IND (Investigational New Drug) to Anixa Bioscience who along with Dr. Touhy and the Cleveland Clinic holds the patent for the vaccine. Dr. Tuohy's ovarian cancer vaccine received an award in 2019 from NCI to reproduce his studies and create the humanized form of the vaccine. The COVID pandemic and budget cuts have stalled the ovarian vaccine.
