Cleveland Clinic's Breast Cancer Vaccine: You Won't Believe What Phase 1 Results Reveal!

Researchers at the Cleveland Clinic are sharing promising final Phase 1 data from a groundbreaking study of an investigational vaccine aimed at preventing triple-negative breast cancer (TNBC), recognized as the most aggressive and lethal form of the disease. The findings, presented at the San Antonio Breast Cancer Symposium, indicate that the vaccine elicited an immune response in 74% of the participants and was shown to be safe and well tolerated.

Dr. G. Thomas Budd, principal investigator of the study at the Cleveland Clinic's Cancer Institute, expressed optimism about the results. “The results from this trial are promising, as they suggest the investigational vaccine is not only safe and well tolerated but also capable of inducing immune responses in over 70% of participants,” he noted.

Funded by the U.S. Department of Defense, this Phase 1 clinical trial (NCT04674306) was conducted in partnership with Anixa Biosciences, Inc. and included 35 patients across three distinct cohorts:

• Phase 1a: Patients who completed treatment for early-stage TNBC within the past three years, are tumor-free, but at high risk for recurrence.
• Phase 1b: Cancer-free individuals carrying genetic mutations that elevate breast cancer risk, who opted for preventative mastectomy.
• Phase 1c: Early-stage TNBC patients treated with pre-operative chemoimmunotherapy and surgery, who have residual cancer and are at risk of recurrence.

The trial, which commenced in 2021, enrolled 26 patients in Phase 1a, four in Phase 1b, and five in Phase 1c. Anixa is planning a Phase 2 study expected to begin in late 2024, lasting approximately two to three years.

The urgency for improved treatments for TNBC cannot be overstated; this subtype accounts for only 10-15% of breast cancer cases but results in a disproportionately high number of deaths from the disease, as highlighted by the American Cancer Society. Alarmingly, TNBC is twice as prevalent among Black women and represents 70-80% of breast tumors in patients with BRCA1 gene mutations.

The vaccine, developed based on pioneering pre-clinical research by the late Vincent Tuohy, Ph.D., was designed to target a lactation protein known as α-lactalbumin. This protein is absent in normal aging breast tissues after lactation but is found in most cases of TNBC. The vaccine aims to stimulate the immune system to target and attack tumors if they appear.

Dr. Tuohy's research demonstrated that activating the immune system against α-lactalbumin was both safe and effective in preventing breast tumors in animal models. His work, which laid the groundwork for this investigational vaccine, was supported by philanthropic donations from over 20,000 contributors over the last 12 years.

“It was Dr. Tuohy's hope that this vaccine would demonstrate the potential of immunization as a new way to combat breast cancer, and that a similar approach could someday be applied to other types of malignancies,” stated Justin Johnson, Ph.D., a researcher in the Cleveland Clinic's Department of Inflammation and Immunity. “Our findings that the majority of participants across all three cohorts demonstrated an immune response to α-lactalbumin is an encouraging sign for the vaccine's potential moving forward.”

Anixa holds the exclusive worldwide license for the novel breast cancer vaccine technology developed at the Cleveland Clinic, with the clinic set to receive royalties and other commercialization revenues from the company. As the research progresses towards Phase 2, the hope is that further studies will validate these initial findings and pave the way for a new preventative strategy against one of the most challenging forms of breast cancer.