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Breast Cancer Vaccine Research

Online Health Chat with Dr. Vincent Tuohy

March 28, 2011


Introduction

Cleveland_Clinic_Host: In the last year, nearly 210,000 new cases of breast cancer were diagnosed in the United States. Breast cancer is the second most common type of cancer among women, yet its cause remains generally unknown. In fact, 70 percent of all women with breast cancer have no identified risk factor.

A team of researchers -- led by Vincent Tuohy, Ph.D, in the Department of Immunology at Cleveland Clinic’s Lerner Research Institute -- recently made high potential findings toward what could become the first-ever vaccine to prevent breast cancer.

The study 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 viruses, or cancers that have already developed. Yet, while viruses are recognized by the immune system as foreign invaders, cancer is not; it is an overdevelopment of the body’s own cells. Trying to vaccinate against this cell overgrowth would effectively be vaccinating against the recipient’s own body, destroying healthy tissue.

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 says. He hopes this vaccine will someday protect women the same way childhood vaccines help children.

The U.S. Food and Drug Administration has approved two cancer-prevention vaccines, one against cervical cancer and one against liver cancer. However, these vaccines target viruses — the human papillomavirus (HPV) and the hepatitis B virus (HBV) — not cancer formation.

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.

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. His laboratory focus involves understanding the complex self-recognition events that lead to progression of autoimmune disease and developing novel therapeutic strategies that prevent disease progression.

The Lerner Research Institute is home to all laboratory-based, translational and clinical research at Cleveland Clinic. Its mission is to understand the underlying causes of human diseases and to develop new treatments and cures.

To make a gift in support of Dr. Tuohy’s research and help usher the breast cancer vaccine into clinical trials, visit giving.ccf.org/vaccine or call 800.223.2273 ext. 41245. Learn more about his work at Lerner Research Institute at http://www.lerner.ccf.org/immuno/tuohy/.

If you are interested in donating toward the breast cancer vaccination project and clinical trials, you may contact Ms. Susan Sasvari, Director of Fund Development for Lerner Research Institute, at sasvars@ccf.org.

Please visit the Cleveland Clinic Lerner Research Institute periodically for updates to the Breast Cancer Vaccine research efforts at: http://www.clevelandclinic.org/breastcancervaccine.

Cleveland_Clinic_Host: Welcome to our Online Health Chat with Dr. Vincent Tuohy. We are thrilled to have him here today to talk about a breast cancer vaccine. Let’s begin with the questions.


Breast Cancer Vaccine

highwaysedge: How will this vaccine better prevent women from getting breast cancer? Also, if a vaccine is made with the actual virus (like many vaccines are), what's to say that the vaccine won't actually give women cancer instead of preventing it?

Dr__Vincent_Tuohy: We're not vaccinating with a virus. We are vaccinating with a substitute for a virus that is expressed in the tumors and not expressed in normal breast tissue. Therefore, we don't see how our vaccine could create cancer.

ByourOWNadvocate: You're targeting a protein found in MOST breast cancers; about what percent of breast cancers?

Dr__Vincent_Tuohy: Since we are not targeting established, mature breast tumors, the presence or absence of α-lactalbumin in such tumors is a moot point. What is important is the presence or absence of this protein in the emerging tumor when it is just starting to grow, and this frequency of occurrence is unknown.

ByourOWNadvocate: You say the protein you're targeting is not seen in healthy women except during lactation. Are you 100 percent sure there are no other environmental or diet factors that could cause creation of this protein in the body?

Dr__Vincent_Tuohy: This is always a possibility. And this is why we do Phase I toxicity studies. For example, lactational foci have been shown to occur in normal breast tissues of women on contraceptive hormone therapy. Therefore, we would not recommend the vaccine to women taking contraceptive hormones.

nystrom: How much does the vaccine reduce your risk of developing breast cancer?

Dr__Vincent_Tuohy: In order to answer that question, we would need to complete the Phase III efficacy trial. In our pre-clinical studies, the vaccine was extremely effective in preventing breast cancer in mice genetically prone to developing this disease.

gina2317: Do you feel that this breakthrough could pave the way for other cancer vaccines?

Dr__Vincent_Tuohy: We have extensive immune protection against childhood diseases in the form of various vaccines. Yet we have no immune protection against adult diseases, including breast, prostate, colon, ovarian, and other cancers. I think that our vaccine strategy can be applied to these cancers, and other adult diseases as well, particularly for patients at high risk for developing such diseases.

ntfinn: Will this vaccine cover ALL types of breast cancer?

Dr__Vincent_Tuohy: I believe it will be effective in preventing all types of breast cancer, but we won't know until we do the trial.

nancy67: If you have identified a protein expressed by a breast cancer cell, is there any thought of using the protein you discovered to identify breast cancer before it becomes detectable by other diagnostic efforts?

Dr__Vincent_Tuohy: There is a great need for a sensitive diagnostic blood test for breast cancer, similar to what serum PSA testing is for prostate cancer. However, we are not developing any diagnostic blood test.


Goals

kailee: I have had breast cancer, had my surgery at main campus and chemotherapy in Weston four years ago. I would really like to know if I should have a vaccine to prevent recurrence. I was 61 when I was diagnosed with estrogen/progesterone positive, Her2 negative invasive breast cancer 0.6 cm micro-calcifications with speculation found by mammogram with no palpable mass at the time, but it got two nodes so I had to have chemotherapy and radiation. I checked with your genetic people to see if my three daughters should be tested since I had breast cancer, and they said no since I was over 50 when I was diagnosed. I would also like to know if my daughters should be vaccinated, and -- if so -- at what age, since I had it?

Dr__Vincent_Tuohy: 95 percent of breast cancers are diagnosed in women 40 years of age or older. Therefore, our ultimate goal is to provide adult women with immune protection against the development of breast cancer. Since viral targets are not currently available for vaccinating against the majority of breast tumors, our vaccine design involves substituting a "self" protein as the target for providing immune protection. This "self" protein is called α-lactalbumin and is expressed in breast tumors but not in normal breast tissue of women unless they are lactating, an event that becomes increasingly less likely with increasing age. Thus, our primary target population is adult women, particularly those at high risk for developing breast cancer who are no longer planning to breastfeed. These are the women taken into consideration when we designed our vaccine. We want to stress that our vaccine was never designed to be used for immunizing children or teenagers, the primary targeted populations for traditional childhood vaccines against infectious diseases.

ming: Regarding the new breast cancer vaccine. Will getting the vaccine take the place of taking Arimidex (anastrozole) for five years after one has gone through chemotherapy and radiation, or does the vaccine only work to prevent someone from getting breast cancer and has no value for the person who has already had breast cancer and has gone through chemotherapy and radiation. In this instance, the person did not have a mastectomy, but the tumor was removed and the margins were clear, although some of the lymph node were positive, thus the need for treatment. Please advise. Thank you!

Dr__Vincent_Tuohy: Our primary goal has always been to provide immune protection against the development of breast cancer in normal, healthy, cancer-free adult women, and our current clinical trials are designed to achieve this goal. We believe that vaccine efficacy in this population of cancer-free women would provide the greatest impact on lowering the incidence of this disease, and this is our overall objective.

Although we are inclined to believe that any immune protection provided by our vaccine in healthy women would also occur in women who have become cancer-free following surgical and chemotherapeutic intervention, we would have to test the ability of the vaccine to provide protection in this population of women. However, we simply do not have the resources to do so at this time and have not planned such testing.

jodilynn: Hi Dr. Tuohy. Will this vaccine target the various types of breast cancer? I had triple negative. Jodi

Dr__Vincent_Tuohy: We have observed expression of our selected target protein (∝-lactalbumin) in triple negative breast tumor cell lines. Therefore, we are optimistic that our vaccine may be effective in preventing such tumors.

stampnjoan: Will the vaccine be effective as prevention for BRCA2 genetic carriers?

Dr__Vincent_Tuohy: The vaccine is designed to prevent breast cancer, particularly in people who are at high-risk, including those with BRCA1 and BRCA2 mutations, or those with a family history that predisposes to the development of breast cancer.


Candidates

rupert: Would you accept out of state patients for this trial?

Dr__Vincent_Tuohy: Both of our proposed Phase I optimization and safety trials will likely be performed locally at Cleveland Clinic and will involve patients willing to participate by coming to the Cleveland Clinic for both immunizations and multiple follow-ups.

sharongv: I am a BRCA1 carrier and have never had breast cancer. I am 55. Would this be an option I would explore?

Dr__Vincent_Tuohy: Yes. You would be the perfect candidate for our vaccine, particularly when we get to advanced clinical trials and test for efficacy, i.e., the ability of our vaccine to prevent breast cancer.

DS27: Will/do the clinical trials include women of all ethnicities or are they focused on one group?

Dr__Vincent_Tuohy: The trial is not restricted to any ethnic group, but it is restricted to women.

stageIVwarrior: Will the possible vaccine have any benefit for woman with metastatic breast cancer; and, as a patient of the Taussig Center, will I have a "first chance" opportunity to be selected for the human trials when they begin?

Dr__Vincent_Tuohy: Our planned Phase I trials will all be done locally (in Cleveland, Ohio). There are inclusion and exclusion criteria that must be met. These will be decided by the physicians in Cleveland.

liltigs122: Will it be a benefit to someone who has already had breast cancer?

Dr__Vincent_Tuohy: The primary target population for our vaccine is normal, healthy, cancer-free adult women.


Women with Cancer

nancy67: I am thinking of a 36-year-old newly diagnosed breast cancer patient whose tumor has been identified as triple negative, and is positive for the BRCA1 gene mutation. Will the breast cancer vaccine research be of interest to her?

Dr__Vincent_Tuohy: We have observed expression of our α-lactalbumin target protein in triple negative breast tumor cell lines. Therefore, we are optimistic that our vaccine may be effective in preventing such tumors. We are planning a second Phase I trial involving women at high risk for developing breast cancer, including those with BRCA mutations who have elected prophylactic mastectomy to reduce their breast cancer risk. We plan to vaccinate them prior to mastectomy and determine the impact of the vaccine on their normal breast tissue, specifically with respect to detection of inflammatory damage.

BaseballFan: Do you foresee this vaccine halting progression of disease in patients who currently are Stage IV?

Dr__Vincent_Tuohy: Our vaccine is not designed as a treatment vaccine. It is designed to prevent breast cancer. While it is possible that this vaccine may treat advanced stage breast cancer, we are focused upon preventing breast cancer in normal, healthy, cancer-free adult women.

rupert: How might this vaccine benefit those who already have stage IV breast cancer?

Dr__Vincent_Tuohy: Our first Phase I trial will focus on determining the dosage and number of injections that will produce an optimized immune response sufficient to provide immune protection from breast cancer. This will be performed in patients with advanced breast cancer. Our second Phase I trial will focus on determining the safety of our vaccine. This will be performed in normal, healthy, cancer-free adult women who have elected prophylactic mastectomy to reduce their risk of developing breast cancer. Although our vaccine is designed to prevent breast cancer, it did provide significant inhibition of tumor growth in mice with established breast cancer.

SallyAnn: I had a lumpectomy last fall, am now receiving chemotherapy and later will have radiation. I was triple negative, stage 2A with one lymph node positive for cancer. Would this vaccine possibly keep the cancer from returning?

Dr__Vincent_Tuohy: It is conceivable that our vaccine could work to prevent breast cancer recurrence. However, we are not planning those clinical trials at this time. We are planning trials to prevent breast cancer in normal, healthy, cancer-free adult women.


Risk

liltigs122: Are there any risks to this vaccine?

Dr__Vincent_Tuohy: The primary risk is producing damage to normal tissue.

BaseballFan: What are the risks involved in the trial?

Dr__Vincent_Tuohy: The primary concern is safety of the vaccine and making sure that it doesn't damage normal breast tissue.


Timing

Carolynpro: When will you test the vaccine in metastatic breast cancer? We are eager for a trial!!

Dr__Vincent_Tuohy: Our first Phase I trial will be on women with metastatic breast cancer. This trial is for dosage, scheduling, and toxicity only, not for efficacy.

rupert: How far out are you from being human trials?

Dr__Vincent_Tuohy: We are awaiting funds to initiate the clinical trials. Once the funding becomes available, we must meet with the Food and Drug Administration (FDA) to satisfy their requirements for starting any clinical trials. These requirements include meeting the FDA’s quality control specifications for manufacture of the vaccine, as well as completing toxicology studies that they may request. We estimate that this process will take up to 1½ years to complete once the funds are in hand. After satisfying the FDA requirements, we will be able to initiate two early Phase I clinical trials.

BaseballFan: When will trials begin?

Dr__Vincent_Tuohy: The trials will begin within 1 to 1½ years after we secure funding. We are currently talking to several organizations about funding.

Croissant_1: What are the roadblocks to getting the vaccine approved and used in the broader market?

Dr__Vincent_Tuohy: Proof of efficacy in a Phase III trial. We estimate that this would take 10 years from the point of funding.


Trial Phases

BaseballFan: What do you hope to accomplish during Phase I trials?

Dr__Vincent_Tuohy: The Phase I trials are designed to optimize the vaccine dose and schedule, and determine safety. These early trials are not designed to determine whether the vaccine is effective in preventing breast cancer.

BaseballFan: How many women do you plan on enrolling in Phase I?

Dr__Vincent_Tuohy: Currently we are planning on two Phase I trials, each consisting of approximately 40 patients.

BaseballFan: How long does a Phase I trial usually last?

Dr__Vincent_Tuohy: We are planning two Phase I trials, and expect them to take a total of approximately 3½ years.

DS27: Which age target group of women will be eligible for the vaccine?

Dr__Vincent_Tuohy: Our two proposed Phase I trials will optimize the immune response to the vaccine and determine its safety profile.


Financial Support

vanders: Is the pre-clinical trial phase on track or still pending? How much money is still needed and how can we help?

Dr__Vincent_Tuohy: We have done extensive pre-clinical testing. We need to go to the FDA to determine what other testing needs to be done prior to clinical trials. We continue to seek funding from several sources.

BaseballFan: Cleveland Clinic is an enormous institution. How much are they contributing to this research? Couldn't they subsidize this extraordinary endeavor?

Dr__Vincent_Tuohy: As is the policy of almost all academic or medical research institutions, external funding is required for research at Cleveland Clinic.


General Questions

BaseballFan: Is the vaccine designed to be a single dose, or multiple injections?

Dr__Vincent_Tuohy: We don't yet know the answer to that question. The Phase I trials will allow us to discover those answers: how much in each dose, how often, etc.

ljan: Is the vaccine delivered through an IV?

Dr__Vincent_Tuohy: No. We are planning to vaccinate subcutaneously.

rupert: Might this vaccine be effective in controlling brain or bone metastases?

Dr__Vincent_Tuohy: We are not currently planning any clinical trials designed to determine efficacy of our vaccine in women with existing tumors or in women in remission. Such trials would be independent of anything we have planned and would require much more extensive funding, which is not currently available to us. However, even though our planned Phase I trials are not designed to determine efficacy, we would be delighted to observe a beneficial effect on metastasis in our first planned Phase I trial on women with advanced breast cancer.

nystrom: Are there any other institutions to your knowledge that are doing the same type of research to develop a breast cancer vaccine?

Dr__Vincent_Tuohy: It is important to distinguish between THERAPEUTIC cancer vaccines designed to treat patients with established tumors and PROPHYLACTIC cancer vaccines designed to prevent tumors from forming in normal, healthy subjects, There are several institutions that are developing therapeutic breast cancer vaccines. There are also a few institutions developing vaccines that prevent breast cancer recurrence and/or the development of new primary tumors in women who have already had breast cancer. Olivera Finn's group at the University of Pittsburgh is conducting a prophylactic vaccine clinical trial targeting MUC1 in normal, healthy, cancer-free patients at high risk for colorectal cancer. However, I know of no other institutions that are attempting to develop immune protection, i.e. prophylactic vaccination, against breast cancer in normal, healthy, cancer-free adult women.

scurvygirl: Has your 'Prevention is the Cure' model changed the way research is accepted by conventional medicine?

Dr__Vincent_Tuohy: The conventional wisdom is that cures will come from treatment. However, I think cures can also come from prevention. Examples of this are polio, smallpox, and other childhood diseases, where vaccines have reduced the incidence dramatically.

Cleveland_Clinic_Host: Please visit the Cleveland Clinic Lerner Research Institute Web site periodically for updates to the Breast Cancer Vaccine research efforts at: www.clevelandclinic.org/breastcancervaccine.


Closing

Cleveland_Clinic_Host: I'm sorry to say that our time with Dr. Vincent Tuohy is now over. Thank you again for taking the time to answer our questions about your research to develop the breast cancer vaccine.

Dr__Vincent_Tuohy: Thank you for spending time with me today. I enjoyed answering your questions. "Prevention is the Cure!"


More Information

To make a gift in support of Dr. Tuohy’s research and help usher the breast cancer vaccine into clinical trials, visit giving.ccf.org/vaccine or call 800.223.2273 ext. 41245. Learn more about his work at Lerner Research Institute at http://www.lerner.ccf.org/immuno/tuohy/.

If you are interested in donating toward the breast cancer vaccination project and clinical trials, you may contact Ms. Susan Sasvari, Director of Fund Development for Lerner Research Institute, at sasvars@ccf.org.

Please visit the Cleveland Clinic Lerner Research Institute periodically for updates to the Breast Cancer Vaccine research efforts at: http://www.clevelandclinic.org/breastcancervaccine.

We do have specialists in our Women's Health and Breast Center at our Main Campus who have extensive experience in diagnosing and treating patients with breast conditions. In case you did not reach the information on our Web site, please use the link below: http://www.clevelandclinic.org/breastcenter.

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