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Cleveland Clinic Breast Cancer Vaccine

What Is The Vaccine For Triple

Cleveland Clinic Launches First-of-Its-Kind Preventive Breast Cancer Vaccine Study

This experimental vaccine is in the early stages of testing with humans.

The long-term goal is to vaccinate healthy people who are at a high risk of developing TNBC. You might be at a high risk of TNBC if you carry certain inherited gene mutations, particularly BRCA1. Such a vaccine might also be helpful to those with a strong family history of breast cancer.

Anyone can develop TNBC. But its often more likely to affect women of African or Hispanic descent. It also tends to occur in women under 40 years old.

In October 2021, Anixa Biosciences and Cleveland Clinic announced the start of dosing patients in a phase 1 trial. The Cleveland Clinic conducted the groundwork for this

Mgm: Molecular & Genetic Markers In Breast Cancer Research Program

Transforming Breast Cancer Treatment: From Standard Therapy to Personalized Care

For 100 years, breast cancer treatment has consisted of a “one size fits all” method for every patient – surgery, radiation and medical treatment. Unfortunately some patients respond better to this standardized protocol for cancer treatment than others. Recent data proves that the genetic makeup of people affects how their body reacts to medication and cancer treatment. Therefore the question becomes, “How do we achieve permanent remission for each breast cancer patient?” As we progress towards this answer, the question then arises, “How best do we predict who will develop cancer and then, how can we try to prevent it?”

Cleveland Clinic: Grounded in Innovation

The late George W. “Barney” Crile, Jr., M.D., the son of one of our founders, was America’s first well-known advocate of tissue-sparing techniques in breast cancer surgery. Fifty years ago, Dr. Crile declared that the future of breast cancer treatment lay not in surgery, but “in the study of chemistry and the very nature of the cancer cell.”

A New Era in Cancer Treatment Emerging

Dr. Crile’s far-seeing wisdom is being realized today by a multidisciplinary team working together to accelerate the transition from standard approaches to breast cancer treatment, to the new age of genetically-based, personalized medicine.

Program Structure

MGM: Providing Hope for Future Breast Cancer Patients

Researchers Announced On Tuesday That They Have Started A Phase 1 Vaccine Clinical Trial In The Fight Against One Of The Deadliest Forms Of Breast Cancer: Triple Negative Breast Cancer

Researchers at Cleveland Clinic announced on Tuesday that they have started a phase 1 vaccine clinical trial in the fight against one of the deadliest forms of breast cancer: triple negative breast cancer.

According to the CDC, triple-negative breast cancer doesn’t have any of the receptors that are usually found in the more common types of breast cancer. This form of cancer doesn’t respond to hormonal therapy, thus giving patients fewer options for treatment.

“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,” G. Thomas Budd, M.D., of Cleveland Clinic’s Taussig Cancer Institute, said in a press release.

Researchers said the intent of the vaccine is to counteract the cancer, though they said it will likely be decades before it is available to the public.

For the trial, the vaccine will be administered to around 18-24 people, all given different dosages to test its efficacy. Those chosen for the trial are patients who have been treated for and overcome early-stage triple-negative breast cancer within the past three years, but who are likely to experience recurrence.

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Cleveland Clinic Launches Trial Examining Preventive Vaccine For Tnbc

In Partnership With:

Cleveland Clinic has partnered with Anixa Biosciences, Inc. to open a phase 1 trial examining a vaccine aimed at preventing the development of triple-negative breast cancer.

Cleveland Clinic has partnered with Anixa Biosciences, Inc. to open a phase 1 trial examining a vaccine aimed at preventing the development of triple-negative breast cancer , according to a press release.1

The study will determine the maximum-tolerated dose of the vaccine in patients with early-stage TNBC, as well as characterize and optimize the bodys immune response to it.

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, principal investigator G. Thomas Budd, MD, of Cleveland Clinics Taussig Cancer Institute, said in a press release. 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.

Additionally, the vaccine will contain an adjuvant that activates an innate immune response and allows the immune system to prevent the growth of these tumors.

Virtual Patient Event: Breast Cancer And Your Genes

Anixa Biosciences, Cleveland Clinic enter license agreement for breast ...

During our virtual patient event, Breast Cancer and Your Genes, members of the Cleveland Clinic Breast Cancer Program discuss genetic testing, how to cope with genetic results and treatment options for patients with genetic related breast cancer and those at high-risk for the development of breast cancer.

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New Breast Cancer Trial Underway At Cleveland Clinic Targets Most Aggressive Form

CLEVELAND Debra Green was diagnosed with stage one breast cancer just before she turned 40.

I remember clearly the day I was diagnosed, what my doctor said to me, and if women can avoid that diagnosis that would be incredible, said Green.

Next month marks 27 years since she got that news.

No one wants to hear those words because once you hear the words you always have this fear, youre going to hear it again, said Green.

Now, Cleveland Clinics Dr. Vincent Tuohy and a team of doctors and researchers are trying to stop other women from being diagnosed with breast cancer.

Tuohy got the idea for a breast cancer vaccine 20 years ago.

These tumor cells, theyre like toddlers they dont pay attention to normal signals. They dont listen to their parents, so to speak, they wreck the place if you let them, said Tuohy.

The investigational vaccine targets a lactation protein, which is no longer found in post-lactation normal aging tissue but is found in the majority of triple-negative breast cancers.

If we aim our immune system and target our immunity against some of these proteins, we believe that we could develop a preemptive immunity that protects women from breast cancer, said Tuohy.

Doctors said the research shows its safe and effective in preventing breast tumors in mice.

The phase one trial is well underway.

During the study, participants receive three vaccinations, each two weeks apart, and are being closely monitored for side effects and immune response.

Vaccine Designed To Prevent Triple

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Researchers at Cleveland Clinic have initiated a first-of-its-kind study of a vaccine designed to ultimately prevent triple-negative breast cancer the deadliest form of the disease.

The phase 1 study will determine the maximum tolerated dose of the vaccine in patients with early stage, triple-negative breast cancer and evaluate immune response to the vaccine. The FDA recently approved the vaccine as an investigational new drug, enabling Cleveland Clinic and partner Anixa Biosciences Inc. to undertake the study.

G.Thomas Budd, MD, Vincent K. Tuohy, PhD,: Cleveland Clinic.

Were in the very first stages, and we need to study the side effects and ensure that the vaccine produces an appropriate immunologic response at a dose that we can safely give,G.Thomas Budd, MD, of Cleveland Clinics Taussig Cancer Institute and principal investigator of the study, said in an interview with Healio. But in the long term, we are optimistic that it will be useful in the preventive setting.

Budd discussed the retired protein hypothesis behind the vaccines development and its potential value against breast cancer.

Healio: How did this vaccine come about?

Healio: What led tothis hypothesis?

Healio: What will the trial entail?

Healio: What will be the next step?

Healio:For which patients would this vaccine ultimately be indicated?

For more information:

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Vaccines As A Cancer Prevention Method

When we think about vaccines, we don’t typically think about cancerthey’re more for viruses like the flu or COVID, right? Not so fast: There’s an HPV vaccine, which has been instrumental in preventing cervical cancer. The exciting news about this breast cancer vaccine trial begs the question: Are we on the precipice of a new phase in the world of medicine, when vaccines are actually used as a cancer prevention tool?

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“Vaccines have been instrumental in the 30-year prolongation of the lifespan of Americans that took place in the 20th century,” Dr. Tuohy says. “Certainly, there have been several other factors that have extended the lifespan of Americans including antibiotics, transplantation, safer working conditions and even clean water and indoor plumbing. However, in my opinion, the adoption of the childhood vaccination program leads the pack in reducing morbidity.”

He adds that we have known for over 40 years that vaccination can prevent cancers, most cancer vaccination studies have focused on using vaccines as treatment vehicles rather than for prophylaxis. “This defies logic,” he says. “We dont wait to get polio or measles and then vaccinate. We provide the immunity preemptively. Prophylactic cancer vaccines are truly part of the future of controlling adult-onset cancers whereas treatment cancer vaccines will likely be part of combination therapy to gain cancer control.”

Why Choose Cleveland Clinic For Breast Cancer Care

Breast Cancer Vaccine Trial: What You Need to Know | Thomas Budd, MD

Our Comprehensive Breast Cancer Program is one of the largest and most specialized in the nation. As part of the Case Comprehensive Cancer, we are one of only 41 comprehensive cancer centers in the nation designated by the National Cancer Institute. Cleveland Clinic has also achieved a Three Year Full Accreditation from the American College of Surgeons’ National Accreditation Program for Breast Centers . Cleveland Clinic is ranked as one of the nations top hospitals by U.S. News & World Report.

Our multidisciplinary physician team of breast surgeons, medical oncologists, radiation oncologists, radiologists, and plastic surgeons work together to provide customized, coordinated care for patients. We offer the highest-quality screening, diagnosis and treatment of breast cancer.

We are a national leader in intraoperative radiation therapy, novel targeted therapies and adjuvant therapies for breast cancer, and also in fertility preservation for cancer patients. We also participate in important clinical trials of brand new therapies and our patients have access to these trials for every stage of breast cancer. Our cancer specialists are pursuing many promising avenues of research including the development of a breast cancer vaccine to bring hope to future patients as well.

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Breast Cancer Q& A

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Dosing Of Cleveland Clinics

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 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 for patients with early-stage disease, announced Anixa Biosciences, Inc, in a press release.1

The vaccine leverages endogenously-produced proteins like -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, -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.

The study will follow a 3 + 3 design in which the vaccine dosing will start at 10 mcg in the dose level 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.


Cleveland Clinic Launches Trial To Test Breast Cancer Vaccine

Cleveland Clinic on Tuesday announced a first-of-its-kind phase I clinical trial to test a vaccine targeting triple-negative breast cancer.

“The vaccine approach represents a potential new way to control breast cancer,” said Vincent Tuohy, a staff immunologist at Cleveland Clinic’s Lerner Research Institute who developed the vaccine with Anixa Biosciences. “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.”

According to Cleveland Clinic, the vaccine targets a breast-specific lactation protein called -lactalbumin. This protein is not found in normal, aging tissues post-lactation, but it is present in the majority of triple-negative breast cancer cases. Activating the immune response against this protein will provide pre-emptive immune protection against emerging breast tumors that express -lactalbumin.

Previously, pre-clinical research led by Tuohy, which was published in Nature Medicine, found that activating the immune system against -lactalbumin was effective at preventing breast tumors in mice. A single vaccination was found to prevent breast tumors from occurring, and it also inhibited the growth of existing tumors in mouse models.

The study is expected to be completed in September 2022.

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Virtual Patient Event: Breast Cancer 101

During our virtual patient event, Breast Cancer 101, experts in Cleveland Clinic’s Breast Cancer Program walk through the experience of a newly diagnosed breast cancer patient. They explain diagnostic testing, medical terminology and factors they consider when making treatment recommendations for patients.

Making Waves In Breast Cancer Prevention

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This vaccine strategy has the potential to be applied to other tumor types, said Vincent K. Tuohy, PhD, the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research at Cleveland Clinic Lerner Research Institute, and primary inventor of the vaccine.

We are living in a time when vaccines, which have proven themselves to be health cares best defense against various illnesses, are under more intense public scrutiny than ever before.

Despite some public divide over vaccines, there is one that it seems everyone should be able to support: a novel vaccine aimed at preventing triple-negative breast cancer.

Developed at Cleveland Clinic, this vaccine works by specifically targeting a breast lactation protein, -lactalbumin, which is not found post lactation in normal, aging tissues but has been found in most triple-negative breast cancers.

Activating the immune system against this protein provides the body with preemptive immunity against breast tumors that express -lactalbumin, as well as preventing any emerging tumors from growing.

This vaccine strategy has the potential to be applied to other tumor types, said Vincent K. Tuohy, PhD, the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research at Cleveland Clinic Lerner Research Institute, and primary inventor of the vaccine.1

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New Study Explores If A Vaccine Can Prevent Breast Cancer

Harnessing the immune system to target cancer has long resided on doctors wish lists, with very little promise of becoming reality. Because cancer cells are normal cells that mutate to grow out of control, directing the body to destroy these cells is a risky endeavor with potentially dangerous outcomes.

Advances in immunotherapy, however, have led to powerful drugs that can help immune cells better distinguish between cancer cells and healthy ones, and researchers are now testing the idea of whether the immune system can be trained to recognize and destroy breast cancer cells in the same way that it dispatches viruses or bacteria.

Dr. G. Thomas Budd, staff physician at the Cleveland Clinic Taussig Cancer Center, is leading a potentially ground-breaking study of a breast cancer vaccine that could help women produce antibodies and other immune cells that protect them from getting cancer. The vaccine is designed to target a particularly aggressive form of the disease, known as triple negative, that currently has very few treatment options. Triple negative cancer lacks the molecular flagsfor estrogen, progesterone or HER2that common breast cancer drugs target.

Results From The 2010 Study With Mice

The 2010 mice study suggested that a vaccine targeting a-lactalbumin may provide safe and effective prevention for breast cancer.

However, its far too soon to know how well it may work in humans. Its also too early to identify potential safety concerns or what the short- and long-term side effects may be.

Researchers can provide more information on these issues following this and subsequent larger trials.

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Inspiring New Strategies To Fight Other Cancers

Dr. Pathak stressed that although vaccine studies have been underway for many years, the silver lining of the COVID-19 pandemic has been their application to cancer, which is extremely exciting.

I think were in the golden era of immune-mediated therapy, and in almost every area of oncology, were using or finding novel uses for immunotherapy and also therapies like vaccines that activate the immune system to both prevent and treat disease. Thats the beauty of translational research where its like bench to bedside, she said.

Weve done this with other types of cancers more preventively with cervical cancer and the human papillomavirus vaccine, and with hepatocellular carcinoma and the hepatitis B vaccine. Those are truly remarkable.

Dr. Bhavana Pathak

Dr. Pathak expressed her hope that in the near future, researchers can find other tissue-specific targets in other diseases, such as prostate, lung, or ovarian cancers which are common and potentially deadly cancers to transform the field of oncology.

And it seems that Dr. Tuohy and his team are already working on a vaccine to prevent epithelial ovarian carcinoma , the most common form of ovarian cancer.

EOC is the most lethal of all gynecologic malignancies, killing


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