Advancing Breast Cancer Prevention: The α-LA Vaccine

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Advancing Breast Cancer Prevention: The α-LA Vaccine

Carina Garcia
June 2025

Breast cancer is the most frequently diagnosed cancer and leading cause of death in women globally. Current treatments require multidisciplinary care, allowing for personalized therapies and treatments accounting for certain biomarkers.[3,8] The standard course of treatment for early-stage breast cancer is breast-conserving surgery with radiotherapy or mastectomy, and dependent on the case, may also incorporate adjuvant systemic therapy as needed. Further, the treatment for metastatic breast cancer aims to optimize patient’s quality of life and survival.[8] Breast cancer care is continuously evolving with new, innovative preventive care and treatments, many of which are currently in development and undergoing trials. Among the advancements underway, a promising vaccine known as the α-Lactalbumin (α-LA) vaccine has drawn interest for its targeted approach, focusing on a breast-specific protein.[7] This novel approach could pave the way for the future of breast cancer prevention and improve women’s health.

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What is α-LA?

α-LA is a breast-restricted protein only expressed during lactation, and it serves as a unique marker for breast cancer.[5,6] Notably, studies have shown that the highest α-LA expression levels were found in patients with stage IV breast cancer. These levels are comparable to those found in women in the last trimester of pregnancy and patients with gynecological cancers. Moreover, the level of α-LA in pregnant females were significantly higher than women with benign breast tumours or non-gynecological cancers and for non-pregnant females and males. Additionally, it is crucial to note that the level of α-LA in patients with stage IV breast cancer were significantly higher than patients with stage I-III breast cancer.[6] Given this context, the elevation of α-LA protein in advanced stages of breast cancer makes it a feasible target for a prophylactic cancer vaccination.[5,7] The groundbreaking concept of an α-LA-targeted vaccine strategy builds upon previous research by the Cleveland Clinic Lerner Research Institute, which successfully found that the α-LA vaccination completely prevented breast cancer growth in mice at risk for the disease.[4,7] Therefore, further understanding the processes that enable the vaccine to target cancerous cells will provide valuable insights into its potential effectiveness in human patients.

The Inner Workings of the Vaccine 

The α-LA vaccine intends to activate the immune system, forming a protective response against breast cancer cells expressing α-LA.[1] Studies indicate the viability of clinically-inducing a proinflammatory immune response against α-LA.[7] Further, this prophylactic vaccine does not cause any significant inflammation in normal, nonlactating breast tissue, thus minimizing the potential risks of the vaccine.[5] The vaccine also contained an immunologic adjuvant, a drug that enhances the immune response against α-LA to prevent tumor growth.[4]

The α-LA vaccine is an experimental drug not yet approved by the Food and Drug Administration (FDA).[2] Recently, Anixa Biosciences, Inc., a biotechnology company, completed a phase-one clinical trial of the α-LA vaccine. This trial focused on individuals who have completed treatment for triple-negative breast cancer (TNBC) as well as those at high risk for the disease or its recurrence.[1,4] 

The aim of the phase-one trial was to determine the optimal dosage for participants with early-stage TNBC and to enhance the immune response to the vaccine. The study also included cancer-free individuals who are at high risk for developing TNBC or who have chosen to undergo prophylactic mastectomy because they have a high genetic risk for the disease.[4] 

The three cohorts of this trial included: 

  1. Participants with high-risk TNBC.
  2. Participants scheduled for prophylactic mastectomy secondary to genetic risk of TBNC.
  3. Participants that are post-TBNC treatment and are receiving adjuvant pembrolizumab.[2]

TNBC is the most aggressive subtype of breast cancer, accounting for 12% to 15% of all breast cancer cases, with a mortality rate of about 25% within five years of diagnosis. At present, the only reliable preventive measure for those at high risk for TNBC is undergoing a mastectomy. Thus, the development of the α-LA vaccine represents a significant step towards alternative preventative care for those affected by or at risk for TNBC.[4]

Optimism at a Professional Level

“We believe we have made significant progress in the development of this vaccine, having recently completed enrollment in the Phase 1 clinical trial. We look forward to the next stage of development and are optimistic about the impact this vaccine could have in the treatment and prevention of breast cancer,” said Amit Kumar, Ph.D, CEO of Anixa Biosciences, Inc.[1] 

The innovative vaccine strategy of the α-LA vaccine inspires a hopeful outlook for the future, where scientific advancements can yield transformative solutions for women’s health.

“Long term, we are hoping that this can be a true preventive vaccine that would be administered to cancer-free individuals to prevent them from developing this highly aggressive disease,” says oncologist Dr. G. Thomas Budd in a statement to the Cleveland Clinic.[4] 

References 

[1] Anixa Biosciences, Inc. (2025, June 3). Anixa biosciences’ breast cancer vaccine featured in NewsNation interview. PR Newswire. https://www.prnewswire.com/news-releases/anixa-biosciences-breast-cancer-vaccine-featured-in-newsnation-interview-302471341.html 

[2] Budd, G. T., & Case Comprehensive Cancer Center. (2025, May 23). Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer. http://clinicaltrials.gov. https://www.google.com/url?q=https://clinicaltrials.gov/study/NCT04674306&sa=D&source=docs&ust=1749942627723910&usg=AOvVaw3E-6rajBTKUGmPdIiRTpKp 

[3] Burguin, A., Diorio, C., & Durocher, F. (2021). Breast cancer treatments: Updates and new challenges. Journal of Personalized Medicine, 11(8), 808. https://doi.org/10.3390/jpm11080808

[4] Cleveland Clinic. (2023, May 15). Is there a vaccine for breast cancer? https://health.clevelandclinic.org/breast-cancer-vaccine-trial

[5] Jaini, R., Kesaraju, P., Johnson, J. M., Altuntas, C. Z., Jane-wit, D., & Tuohy, V. K. (2010). An autoimmune-mediated strategy for prophylactic breast cancer vaccination. Nature Medicine, 16(7), 799-803. https://doi.org/10.1038/nm.2161

[6] Thean, E., & Toh, B. (1990). Serum human α-lactalbumin as a marker for breast cancer. British Journal of Cancer, 61(5), 773-775. https://doi.org/10.1038/bjc.1990.173 

[7] Tuohy, V., Jaini, R., Johnson, J., Loya, M., Wilk, D., Downs-Kelly, E., & Mazumder, S. (2016). Targeted vaccination against human α-lactalbumin for immunotherapy and primary Immunoprevention of triple negative breast cancer. Cancers, 8(6), 56. https://doi.org/10.3390/cancers8060056


[8] Wang, J., & Wu, S. (2023). Breast cancer: An overview of current therapeutic strategies, challenge, and perspectives. Breast Cancer: Targets and Therapy, 15, 721-730. https://doi.org/10.2147/bctt.s432526