Key Takeaways

On December 21, the Food and Drug Administration (FDA) approved an investigational drug application for a triple-negative breast cancer vaccine that could reduce the incidence of advanced disease. The brainchild of Vincent Tuohy, PhD, a researcher in the department of inflammation and immunity at the Cleveland Clinic’s Lerner Research Institute, the vaccine has been preemptively licensed to the biotechnology company Anixa Biosciences.

Triple-negative breast cancer—so named because it does not produce receptors for the hormones estrogen and progesterone and only produces HER2, the receptor for the protein human epidermal growth factor, in small amounts—accounts for about 10-15% of all breast cancers, making it one of the disease’s rarer incarnations.

Triple-Negative Breast Cancer

“Most triple-negative breast cancers express alpha-lactalbumin," Tuohy says. “It is a mistake that the tumors make because they have no default inhibition mechanisms through progesterone and estrogen signaling that would ordinarily prevent the expression of this protein.” He describes the vaccine mechanism as “simply taking advantage of this mistake.”

What This Means For YouIt’s not currently known when this vaccine may be available to the general public. If it proves to be effective and approved for use several years down the line, you will not be eligible to receive the vaccine if you are breastfeeding or plan to breastfeed in the future.

What This Means For You

It’s not currently known when this vaccine may be available to the general public. If it proves to be effective and approved for use several years down the line, you will not be eligible to receive the vaccine if you are breastfeeding or plan to breastfeed in the future.

What Happens Next?

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The Future of Cancer Vaccine Development

Cancer vaccines can be divided into two camps: those designed to prevent cancer, like Tuohy’s, and those designed to treat it. The only direct cancer treatment vaccines currently available are sipuleucel-T/Provenge (for the treatment of advanced prostate cancer) and talimogene laherparepvec/T-VEC (for the treatment of advanced melanoma, an aggressive form of skin cancer).

Many breast cancer treatment vaccines are in development, including peptide-based vaccines, whole-cell vaccines, gene-based vaccines, and dendritic cell-based vaccines, but none have yet advanced past Phase II clinical trials.

The candidates hail from organizations all around the country, including the Mayo Clinic in Jacksonville, Florida, the University of Washington in Seattle, and the University of Texas M.D. Cancer Center in Houston, according to Pravin Kaumaya, PhD, professor of translational therapeutics at the Ohio State University Comprehensive Cancer Center.

Looking Ahead

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“So we envision a 21st-century vaccine program here at the Cleveland Clinic that prevents diseases that we confront with age that we think are completely preventable,” Tuohy told Fox 8. “We think breast cancer, ovarian cancer, [and] perhaps prostate cancer are all preventable diseases, and that’s why we want to bring our vaccine program up to the 21st century.”

For his part, Kaumaya believes that any successful breast cancer treatment vaccine will need to include checkpoint inhibitors—drugs that prevent cancer cells from acting on the immune system.

“The bottom line is for a vaccine to be successful, you’re going to have to incorporate multiple modalities," he says. “And to me, what is most important at this stage is the inclusion of checkpoint inhibitors. That combination of immunotherapies is going to be essential for any of us developing breast cancer vaccines to be successful.”

7 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Jordan, J.FDA clears way for Cleveland Clinic’s groundbreaking breast cancer vaccine. Fox 8.American Cancer Society.Triple-negative breast cancer.BioSpace.Anixa Biosciences and Cleveland Clinic file IND application for breast cancer vaccine.American Cancer Society.Cancer vaccines and their side effects.Allahverdiyev A, Tari G, Bagirova M, Abamor ES.Current approaches in development of immunotherapeutic vaccines for breast cancer.J Breast Cancer. 2018;21(4):343-353. doi:10.4048/jbc.2018.21.e47Sasaki T, Hiroki K, Yamashita Y.The role of epidermal growth factor receptor in cancer metastasis and microenvironment.Biomed Res Int. 2013;2013:546318. doi:10.1155/2013/546318Bekaii-Saab T, Wesolowski R, Ahn DH, et al.Phase i immunotherapy trial with two chimeric her-2 b-cell peptide vaccines emulsified in montanide isa 720vg and nor-mdp adjuvant in patients with advanced solid tumors.Clin Cancer Res. 2019;25(12):3495-3507. doi:10.1158/1078-0432.CCR-18-3997

7 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Jordan, J.FDA clears way for Cleveland Clinic’s groundbreaking breast cancer vaccine. Fox 8.American Cancer Society.Triple-negative breast cancer.BioSpace.Anixa Biosciences and Cleveland Clinic file IND application for breast cancer vaccine.American Cancer Society.Cancer vaccines and their side effects.Allahverdiyev A, Tari G, Bagirova M, Abamor ES.Current approaches in development of immunotherapeutic vaccines for breast cancer.J Breast Cancer. 2018;21(4):343-353. doi:10.4048/jbc.2018.21.e47Sasaki T, Hiroki K, Yamashita Y.The role of epidermal growth factor receptor in cancer metastasis and microenvironment.Biomed Res Int. 2013;2013:546318. doi:10.1155/2013/546318Bekaii-Saab T, Wesolowski R, Ahn DH, et al.Phase i immunotherapy trial with two chimeric her-2 b-cell peptide vaccines emulsified in montanide isa 720vg and nor-mdp adjuvant in patients with advanced solid tumors.Clin Cancer Res. 2019;25(12):3495-3507. doi:10.1158/1078-0432.CCR-18-3997

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Jordan, J.FDA clears way for Cleveland Clinic’s groundbreaking breast cancer vaccine. Fox 8.American Cancer Society.Triple-negative breast cancer.BioSpace.Anixa Biosciences and Cleveland Clinic file IND application for breast cancer vaccine.American Cancer Society.Cancer vaccines and their side effects.Allahverdiyev A, Tari G, Bagirova M, Abamor ES.Current approaches in development of immunotherapeutic vaccines for breast cancer.J Breast Cancer. 2018;21(4):343-353. doi:10.4048/jbc.2018.21.e47Sasaki T, Hiroki K, Yamashita Y.The role of epidermal growth factor receptor in cancer metastasis and microenvironment.Biomed Res Int. 2013;2013:546318. doi:10.1155/2013/546318Bekaii-Saab T, Wesolowski R, Ahn DH, et al.Phase i immunotherapy trial with two chimeric her-2 b-cell peptide vaccines emulsified in montanide isa 720vg and nor-mdp adjuvant in patients with advanced solid tumors.Clin Cancer Res. 2019;25(12):3495-3507. doi:10.1158/1078-0432.CCR-18-3997

Jordan, J.FDA clears way for Cleveland Clinic’s groundbreaking breast cancer vaccine. Fox 8.

American Cancer Society.Triple-negative breast cancer.

BioSpace.Anixa Biosciences and Cleveland Clinic file IND application for breast cancer vaccine.

American Cancer Society.Cancer vaccines and their side effects.

Allahverdiyev A, Tari G, Bagirova M, Abamor ES.Current approaches in development of immunotherapeutic vaccines for breast cancer.J Breast Cancer. 2018;21(4):343-353. doi:10.4048/jbc.2018.21.e47

Sasaki T, Hiroki K, Yamashita Y.The role of epidermal growth factor receptor in cancer metastasis and microenvironment.Biomed Res Int. 2013;2013:546318. doi:10.1155/2013/546318

Bekaii-Saab T, Wesolowski R, Ahn DH, et al.Phase i immunotherapy trial with two chimeric her-2 b-cell peptide vaccines emulsified in montanide isa 720vg and nor-mdp adjuvant in patients with advanced solid tumors.Clin Cancer Res. 2019;25(12):3495-3507. doi:10.1158/1078-0432.CCR-18-3997

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