Dosing of Cleveland Clinic’s α-Lactalbumin Vaccine Begins in Phase 1 Breast Cancer Study

After discovering the potential of a prophylactic breast cancer vaccine, Cleveland Clinic will be the site of a phase 1 clinical trial to test its safety.

Following the discovery of a novel approach to prevent triple-negative breast cancer (TNBC) at the Lerner Research Institute of Cleveland Clinic, dosing of a novel prophylactic breast cancer vaccine has begun in a phase 1 study that aims to determine the maximum tolerated dose (MTD) for patients with early-stage disease, announced Anixa Biosciences, Inc, in a press release.1

The vaccine leverages endogenously-produced proteins like α-lactalbumin and others to activate the immune system against breast tumors that express the protein. The response generated from this vaccine prevents tumors from growing. Prior to the launch of the phase 1 study, preclinical research showed that the protein, α-lactalbumin, may protect against breast cancer in women who are post- or premenopausal, and at high risk for developing breast cancer.1,2

Overall, the study set the benchmark for antigen selection in the development of a targeted prophylactic cancer vaccine warranting its development to work against breast cancer in humans.

In the phase 1 study (NCT04674306), 18 to 24 patients with TNBC who have completed treatment for their disease within the past 3 years, and are cancer free but are at a high risk for disease recurrence will receive the novel vaccine at the Cleveland Clinic. A total of 3 vaccinations will be administered to the study subjects 2 weeks apart and patients will be monitored closely for investigators to determine the MTD and the lowest immunologic dose of the vaccine.1,3

The study will follow a 3 + 3 design in which the vaccine dosing will start at 10 mcg in the dose level (DL) 1 cohort and climb to 1000 mcg in the DL3 cohort. In combination with the vaccine, patients will receive a matching dose level of zymosan.

“We are hopeful that this research will lead to more advanced trials to determine the effectiveness of the vaccine against this highly aggressive type of breast cancer,” said G. Thomas Budd, MD, physician, Department of Hematology and Medical Oncology in the Taussig Cancer Center, at the Cleveland Clinic and principal investigator of the study, in a press release.4 “Long term, we are hoping that this can be a true preventive vaccine that would be administered to healthy women to prevent them from developing triple-negative breast cancer, the form of breast cancer for which we have the least effective treatments.”

Patients are eligible to enroll in the study given they have histologically proven disease that is estrogen-receptor negative, HER2-negative and progesterone receptor-negative. Other inclusion requirements include an ECOG performance status of 0 or 1, adequate major organ function, and a serum prolactin level lower than the upper limits of normal.3

In terms of unmet medical needs, the study may address the issue of low response rate to hormonal therapy and some targeted therapies in addition to the high death rate, which disproportionally impacts Black American women. In addition, 70% to 80% of TNBC cases are also positive for BRCA1 mutations, making treatment more challenging.1,4

“This vaccine approach represents a potential new way to control breast cancer,” said Vincent Tuohy, PhD, The Mort and Iris November distinguished chair in Innovative Breast Cancer Research at the Lerner Research Institute, Cleveland Clinic, and the primary inventor of the vaccine, in the press release.4 “The long-term objective of this research is to determine if this vaccine can prevent breast cancer before it occurs, particularly the more aggressive forms of this disease that predominate in high-risk women.”

The study is the first of its kind, according to Anixa Biosciences, Inc. “Our vaccine has the potential to prevent the development of the most aggressive form of breast cancer – triple-negative breast cancer. We look forward to the prospect of advancing this promising candidate throughout later stage studies,” said Amit Kumar, MD, president and chief executive officer, Anixa Biosciences, Inc, in a press release.1


1. Anixa Biosciences announces patient dosing of its investigational vaccine candidate in a first-of-its-kind preventative breast cancer vaccine study. News release. Anixa Biosciences. October 26, 2021. Accessed October 26, 2021.

2. Adjuvant therapy with an alpha-lactalbumin vaccine in triple-negative breast cancer. Accessed October 26, 2021.

3. Cleveland Clinic launches first-of-its-kind preventive breast cancer vaccine study. News release. Cleveland Clinic. October 26, 2021. Accessed October 26, 2021.

4. Jaini R, Kesaraju P, Johnson JM, et al. An autoimmune-mediated strategy for prophylactic breast cancer vaccination. Nat Med. 2010;16(7):799-803. doi: 10.1038/nm.2161