Researchers from Cleveland Clinic recently presented updated findings from a novel study of a vaccine aimed at preventing triple-negative breast cancer. The findings were presented at the Society for Immunotherapy of Cancer Annual Meeting.1
G. Thomas Budd, MD
According to researchers, including principal investigator of the phase I study, G. Thomas Budd, MD, of Cleveland Clinic, the investigational vaccine was generally well tolerated and produced an immune response in most patients. The team described the side effects of the vaccine, showed the highest tolerated dose to date, and presented the immunologic effects of the vaccine.
The investigational vaccine is based on preclinical research led by the late Vincent Tuohy, PhD, who was the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research at Cleveland Clinic’s Lerner Research Institute. The vaccine targets a lactation protein, α-lactalbumin, which is no longer found after lactation in normal, aging breast tissues but is present in most triple-negative breast cancers. If breast cancer develops, the vaccine is designed to prompt the immune system to attack the tumor and keep it from growing.
The study is based on Dr. Tuohy’s research that showed that activating the immune system against α-lactalbumin was safe and effective in preventing breast tumors in mice. The research originally was published in Nature Medicine.2
Launched in 2021 and funded by the U.S. Department of Defense, the ongoing clinical trial is evaluating safety and monitoring immune response of the vaccine. The phase I study was conducted at Cleveland Clinic’s main campus in partnership with Anixa Biosciences, Inc, and has included 26 patients to date across three cohorts:
- Phase IA includes patients who completed treatment for early-stage, triple-negative breast cancer within the past 3 years and are currently tumor-free but at high risk for recurrence.
- Phase IB includes individuals who are cancer-free and at high risk for developing breast cancer who have elected to voluntarily have a preventive mastectomy to lower their risk. Primarily, these are women with BRCA1, BRCA2, and PALB2 mutations.
- Phase IC includes patients with early-stage triple-negative breast cancer who have received preoperative chemoimmunotherapy and surgery and are being treated with pembrolizumab following surgery. These patients have residual cancer in the breast tissue, making them at risk of recurrence.
For more information and eligibility requirements visit ClinicalTrials.gov (NCT04674306).
DISCLOSURE: For full disclosures of the study authors, visit jitc.bmj.com.
REFERENCES
1. Rhoades EE, Johnson JM, Levengood H, et al: Phase I trial of alpha-lactalbumin vaccine in patients with high-risk early triple-negative breast cancer (TNBC) and those at genetic risk for TNBC. J Immunother Cancer 12(suppl 2):631, 2024.
2. Jaini R, Kesaraju P, Johnson JM, et al: An autoimmune-mediated strategy for prophylactic breast cancer vaccination. Nat Med 16:799-803, 2010.
