Dr. Tuohy participated in a live webchat on March 28, 2011 12 pm (EST)
In the News
Success in the Lab
A team of researchers led by Vincent Tuohy, PhD, in the Department of Immunology at Cleveland Clinic’s Lerner Research Institute, recently made discoveries toward what could become the first-ever vaccine to prevent breast cancer.
The study, published in Nature Medicine, found that a single vaccination with the protein α-lactalbumin prevents breast tumors from forming in mice, while also inhibiting the growth of already existing tumors.
Most attempts at cancer vaccines have targeted tumors after they have already developed. These approaches have inherent limitations since the tumor has had a head start by entrenching itself, spreading and producing factors that elude immune elimination.
An Autoimmune Approach
As an autoimmune immunologist, rather than a traditional cancer researcher, Dr. Tuohy’s approach is completely different — attacking the tumor before it can develop.
“Our immune system has a great capacity to protect us from many things, but we fail to take full advantage of it,” he has said.
He hopes this vaccine will some day protect women from developing breast cancer in the same way childhood vaccines effectively protect children from diseases like measles and polio.
The U.S. Food and Drug Administration (FDA) has approved two cancer-prevention vaccines, one against cervical cancer and one against liver cancer. However, these are conventional vaccines that target viruses — the human papillomavirus (HPV) and the hepatitis B virus (HBV) — not the cancer cells as they appear.
How the Vaccine Would Work
Dr. Tuohy and his team targeted a protein (α-lactalbumin) found in the majority of breast cancers, but not found in healthy women, except during lactation. Therefore, the vaccine can rev up a woman’s immune system to target the protein — and stop tumor formation — without damaging healthy breast tissue.
If proven successful in clinical testing, the strategy likely would be to vaccinate women over 40 — when breast cancer risk begins to increase and pregnancy becomes less likely. For younger women with a heightened risk of breast cancer, the vaccine may be an option to consider instead of preventive mastectomy.
Potential for Affecting Other Diseases
The process from the lab to humans is in the earliest stages, as Dr. Tuohy continues to seek funding for clinical trials. His team is also proactively working on the “next generation” vaccine, along with subsequent research to develop similar vaccine strategies against other cancers.
On staff at Cleveland Clinic since 1989, Dr. Tuohy’s research interests include autoimmunity, cancer vaccination, hearing loss, heart failure, multiple sclerosis and ovarian failure.
What’s the process of moving research findings into clinical trials?
Once funding is secured, Dr. Tuohy and his team can start preparing for FDA approval of clinical trials in humans.
Clinical trials are designed to demonstrate the safety and efficacy of the vaccine before FDA approval for general use can be obtained. This process will include distinct phases, each taking several years.
Pre-Clinical Trial Phase
Preparation for FDA approval
Duration: 1.5 years (est.)
Cost: $2 million (est.)
Clinical Trial Phase I
Ensuring safety and optimization of the vaccine
Duration: 3-4 years (est.)
Cost: $4 million (est.)
The research team is poised today to take this discovery from the lab to clinical trials; the sole hurdle is a lack of funding.
While Dr. Tuohy continues to seek funding for clinical trials, his team is also proactively working on the “next generation” vaccine, along with subsequent research to develop similar vaccine strategies against other cancers.
Applications for external funding are in progress, but philanthropic support could jump-start human trials and engage immediate exploration of the vaccine's true effectiveness.
With gifts ranging from $5 to $250,000, individuals have raised nearly $763,000 as of April 2012.
"To get through the early clinical trials of a vaccine will cost $1.2 million a year for five years, a formidable obstacle," says Dr. Tuohy. "It will cost $1 million just to put the vaccine in a bottle because of Food and Drug Administration quality control mandates."
How does this vaccine differ from other vaccine attempts?
The vaccine is a preventative measure; others have been designed and researched to treat breast cancer once the disease develops. The vaccine is targeting the tumor before it develops. Dr. Tuohy’s approach is based on an immune attack against self-antigens over-expressed in breast tumors and under-expressed in normal breast tissue.
What is the hope for this vaccine down the road?
It will become a vaccine for the next generation. Studying this prototype vaccine also will open up opportunities to develop vaccines to prevent other types of cancer. The hope for this vaccine is that it will someday be used to prevent breast cancer in adult women, the same way the childhood vaccines protect children from diseases like measles and polio.
Will the clinical trials enroll women who have had previous breast cancer or women who have never had the disease?
The first phase of the clinical trial will be with patients who have metastatic disease. The main goal is to determine if the vaccine is safe without any major side effects. The team will need to determine what kind of dose, how much protein should be in each immunization and how many immunizations are needed to produce an optimized immune response.
The second phase will be with patients who are at high risk for developing breast cancer due to genetic or family history factors that predispose them to this disease and have already chosen prophylactic mastectomy. In addition to determining the questions above, the team will examine the breast tissue after it is removed from vaccinated women.
Will human clinical trials start anytime soon?
Once we receive funding, we can begin the process leading to clinical trials at Cleveland Clinic. The vaccine will take approximately ten years to test and develop.
See the "Project Timeline" tab to learn about steps involved in moving from the lab to clinical trials.
To speak with a representative about a consultation with a specialist, call 216.444.3024 (toll-free 800.223.2273 ext. 43024).
Opportunity for Support
To make a gift in support of Dr. Tuohy’s research and help usher the breast cancer vaccine into clinical trials: