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Vaccine For Triple Negative Breast Cancer

Online Consultation

Medilink Consultant clinic

Saad Ullah Siddiqui

Triple-negative breast cancer (TNBC) accounts for 15% of all breast cancer cases<a href="#accordion">[6]</a>. Despite the low prevalence, it accounts for a majorly high percentage of breast cancer-related deaths.

TNBC is more common in younger women (aged less than 40 years), Blacks or Hispanics, and those with BRCA mutations. 
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Compared to other types of invasive breast cancer, it is more aggressive and has fewer treatment options. The high risk of recurrence gives the cancer a poor prognosis. Moreover, it has one of the worst survival outcomes among other breast cancer subtypes.

The cancer is called triple-negative because it lacks estrogen or progesterone receptors (ER and PR), and HER2 protein. Due to its molecular characteristics, hormonal or targeted therapies are ineffective against TNBC, and chemotherapy in combination with surgery is the only effective option. Thus, there is a need for improved treatments. 
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In recent years, there have been significant advancements in the treatment of triple-negative breast cancer (TNBC) using targeted therapies like PARP inhibitors, immune checkpoint blockers (ICBs), and antibody-drug conjugates (ADCs). Among these, ICBs have shown promising results in improving response rates and reducing disease progression when combined with chemotherapy. However, a major challenge with ICBs is that only a small fraction of patients benefit from the treatment in the long term, as resistance to ICBs can develop. To overcome this, researchers are exploring ways to modify the tumor microenvironment (TME) to prevent immune escape mechanisms. 
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One approach is using cancer vaccines to activate specific immune responses against tumor cells. While vaccines have been successful in preventing some infectious-based cancers, their effectiveness in cancer prevention and treatment is still being investigated. Different types of cancer vaccines with various targets and delivery methods have been tested, but their clinical benefits have been limited, partly due to immune escape mechanisms and suppressive cells in the TME. To improve the outcomes of vaccine therapy, further research is needed to optimize the development process and explore combination therapy strategies. Although preclinical studies have shown promise, more research is required to determine the safety and efficacy of cancer vaccines for TNBC in clinical settings. 
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Overview

Breast cancer is the leading cause of cancer-related deaths among women. In 2020, it accounted for an estimated 685,000 deaths<a href="#accordion">[1]</a>. Unfortunately, these numbers are only expected to rise further as experts predict 3 million new <a href="https://merisehat.pk/disease/breast-cancer">breast cancer</a> cases and 1 million deaths in 2040<a href="#accordion">[1]</a>. 
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Despite significant advancements in treatment, early detection, and awareness campaigns, the burden of breast cancer continues to take a toll on countless lives. Thus, there is a need for a preventive vaccine against breast cancer. Such a breakthrough would not only offer hope for a future free from the fear of breast cancer but also provide an essential tool to help combat this complex and widespread disease, potentially saving numerous lives and alleviating the social and economic burden it imposes on individuals and societies. 
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understanding Vaccine For Triple Negative Breast Cancer

The novel vaccine works by targeting a lactation protein called &alpha;-lactalbumin. While the protein is not normally present post-lactation, it is present in a majority of triple-negative breast cancers. The vaccine activates the immune system against the protein, ultimately protecting emerging breast tumors possessing the protein.&nbsp;

Invented by the late Dr. Vincent Tuohy, the vaccine also contains an adjuvant that activates innate immunity, allowing the immune system to elicit a response against any emerging tumors and prevent them from growing.&nbsp; 
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In 2021, researchers from Cleveland Clinic launched the first-of-its-kind preventive breast cancer vaccine trial. The Phase Ia trial included women who had triple-negative breast cancer within the last three years and were tumor-free but had a high risk of recurrence<a href="#accordion">[2]</a>. Patients received a total of 3 doses, once every 2 weeks. The clinical trial aimed to determine the maximum tolerable dose and detect any immunologic response in the dosed patients.

According to recent reports, the vaccine managed to elicit an immune response across all study participants<a href="#accordion">[3]</a>. However, researchers believe it is too early to determine whether this elicited immune response is enough to effectively prevent cancer in people with a high risk. 
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A Phase Ib study is also currently underway. It includes two cohorts of patients: one comprises patients with high-risk triple-negative breast cancer, and the second is made up of participants scheduled for a bilateral prophylactic mastectomy due to their genetic risk. The trial aims to determine the maximum tolerated dose among these patients and determine if the participants mount an immunologic response<a href="#accordion">[4]</a>. It is expected to be completed by the end of 2023.

The groundwork for both these studies was conducted in 2010 in a mice model which suggested that targeting the specific protein can provide a safe and effective vaccine option for breast cancer<a href="#accordion">[5]</a>. 
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Conclusion

While the experimental vaccine is promising, there&rsquo;s still a long way to go till it can receive approval for use among the public. Nevertheless, the development of the vaccine paves the possibility for vaccines against other types of malignancy. 
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Key Points

<ul>
	<li>Breast cancer is a leading cause of cancer-related deaths among women, with increasing cases and deaths projected for the future.</li>
	<li>Despite advancements in treatment and awareness, breast cancer continues to be a significant burden, necessitating a preventive vaccine.</li>
	<li>Triple-negative breast cancer (TNBC) is an aggressive subtype with limited treatment options and poor survival rates.</li>
	<li>TNBC lacks estrogen, progesterone, and HER2 receptors, making hormonal or targeted therapies ineffective, and chemotherapy with surgery is the primary option.</li>
	<li>A Phase Ia trial for a preventive breast cancer vaccine targeting a lactation protein showed promising immune responses in high-risk patients.</li>
	<li>A Phase Ib study is ongoing to determine the maximum tolerated dose and immunologic response in high-risk patients.</li>
	<li>The novel vaccine targets a lactation protein found in TNBC, activating the immune system to protect against emerging breast tumors.</li>
	<li>Advancements in immunotherapies, including cancer vaccines, show promise, but more research is needed to optimize their effectiveness in clinical settings.</li>
	<li>The experimental vaccine represents hope for future cancer vaccines and improved treatments, but further development and approval are required. 
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</ul>

[1] Arnold M, Morgan E, Rumgay H, et al. Current and future burden of breast cancer: Global Statistics for 2020 and 2040. The Breast. 2022;66:15-23. doi:10.1016/j.breast.2022.08.010

[2] Anixa Biosciences. Anixa biosciences announces patient dosing of its investigational vaccine candidate in a first-of-its-kind preventative breast cancer vaccine study. PR Newswire: press release distribution, targeting, monitoring and marketing.

[3] Newton W. Anixa’s breast cancer vaccine shows promise in phase I trial. Clinical Trials Arena.

[4] Adjuvant therapy with an alpha-lactalbumin vaccine in triple-negative breast cancer - full-text view. ClinicalTrials.gov.

[5] Jaini, R., Kesaraju, P., Johnson, J. et al. An autoimmune-mediated strategy for prophylactic breast cancer vaccination. Nat Med 16, 799–803 (2010). DOI:10.1038/nm.2161

[6] Hosseini M, Seyedpour S, Khodaei B, et al. Cancer Vaccines for Triple-Negative Breast Cancer: A Systematic Review. Vaccines (Basel). 2023;11(1):146. Published 2023 Jan 9. doi:10.3390/vaccines11010146