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.
Cleveland Clinic Breast Cancer Vaccine Goes To Clinical Trials
Cleveland Clinic researchers are getting ready to embark on a clinical trial testing a breast cancer vaccine.
The Food and Drug Administration recently greenlighted a breast cancer vaccine technology developed at Cleveland Clinic, which allows clinical trials for the vaccine to move forward.
If effective, the vaccine could become a regular part of womens health care, said Dr. Vincent Tuohy, a cancer researcher at the clinic who invented the vaccine.
The long-term vision is a woman reaches 40 years old or so, she reaches the high-risk area age for breast cancer, she could come in to her doctor and get her breast cancer vaccine, Tuohy said.
The vaccine is for triple negative breast cancer, one of the most lethal forms of the disease. So far, the vaccine has only been tested in animals.
The shot protects against alpha-lactalbumin, a protein in women’s mammary glands that no longer appears after childbearing years but shows up in many cases of triple negative breast cancer, he said.
The idea behind taking this vaccine is the bodys immune response would destroy cancer cells before they develop and mature, Tuohy said.
Why do these tumors express these proteins? We dont know. They make a mistake, he said. Im trying to take advantage of the mistake the tumors make. Wed have to be crazy not to.
In animal trials, the vaccine was shown to be very effective, Tuohy added.
Researchers hope to eventually test the vaccine on women in the general population.
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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?
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Choosing The Right Adjuvant
The selection of the adjuvant component for the preventive vaccine was critical, both in terms of its ability to activate the aggressive proinflammatory T-cell response needed for effective tumor immunity, and to pass regulatory scrutiny. Adjuvants are necessary to activate the innate immune response for orchestrating the adaptive immune response and conferring immunological memory.
The adjuvant is the irritant, Dr. Tuohy says. It provides the danger signal. So now the immune system sees -lactalbumin in the context of a danger signal and activates the entire cascade of innate and adaptive immunity.
Dr. Tuohy and his colleagues tested multiple adjuvants that proved to be inferior before developing a weakened version of complete Freunds adjuvant .
CFA desiccated mycobacterium suspended in mineral oil is a potent anti-inflammatory agent whose use in humans is prohibited and in research animals is limited due to its toxicity and potential to cause granulomas and abscesses.
G. Thomas Budd, MD, is the breast cancer vaccine trials principal investigator and Vincent Tuohy, PhD, is the vaccines primary inventor.
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Anixa Begins Phase Ib Trial Of Breast Cancer Vaccine
The company plans to conclude the trial by the end of next year.
Anixa Biosciences has begun a Phase Ib clinical trial of its preventative breast cancer vaccine.
Being carried out at the Cleveland Clinic in the US, the trial will assess the safety and observe the immune response in subjects.
The trial is financed through a grant from the US Department of Defense .
Healthy, cancer-free subjects, who are at increased risk of breast cancer development and who chose to undergo a voluntary bilateral mastectomy to reduce risk, will be recruited into the trial.
These women usually have BRCA1 or associated gene mutations, which puts them at risk of triple-negative breast cancer development or high familial risk for any kind of breast cancer.
Trial subjects will be given three vaccinations at a gap of two weeks and analysed for side effects and immune response.
The company plans to conclude the trial by the end of next year.
The vaccine leverages endogenously generated proteins that serve a purpose at specific points in life, before becoming retired and disappear from the body.
It also has an adjuvant for activating an innate immune response.
A Phase Ia trial of the vaccine is currently underway in patients who have received treatment for early-stage TNBC in the last three years and are tumour-free at present, but are also at increased recurrence risk.
Taking Aim At Primary Prevention
Most breast cancer vaccines presently in development are meant to treat patients with existing tumors or to prevent recurrence in cancer survivors.
Current data indicate that therapeutic vaccines have limited efficacy, at least in part because they employ target antigens that fail to induce a clinically relevant immune response and adjuvants that dont adequately enhance the response. Only one breast cancer vaccine has progressed to phase III trials, and that randomized trial was terminated for futility when interim analysis showed no difference in disease-free survival between the vaccine and placebo.
Dr. Tuohys experimental vaccine is aimed at primary prevention stopping cancer before tumors develop.
We know from the childhood vaccine program that vaccines are to prevent disease, he says. You dont wait to get polio or measles and then vaccinate. But the entire field of cancer vaccination was using vaccines to treat. And I thought that wasnt right. As a standalone, therapeutic cancer vaccines have not worked well, primarily because of the tumors substantial head start in growth, the onset of clinical symptoms, the establishment of tumor defenses against the immune response, and the potential for local and distant metastasis.
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Clinical Trial Launched For Preventive Breast Cancer Vaccine
Cleveland Clinics Lerner Research Institute has initiated a new study to examine a vaccine to prevent triple-negative breast cancer.
Cleveland Clinic announced this week that it has opened a phase 1 trial to examine a new vaccine to prevent triple-negative breast cancer.
Researchers at the Lerner Research Institute will use the trial to figure out what the maximum tolerated dose of the vaccine is in patients with early-stage triple-negative breast cancer .
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, said lead study investigator Dr. G. Thomas Budd of Cleveland Clinics Taussig Cancer Institute in a release.
The Food and Drug Administration recently approved an investigational new drug application for the vaccine, enabling the researchers at Cleveland Clinic and partner Anixa Biosciences, Inc. to initiate the study.
Although TNBC is a less common form of breast cancer, new treatment methods are much needed, as it accounts for a higher percentage of deaths and recurrences. It is also been shown to disproportionately affect African American women.
A follow-up trial is also anticipated, in which researchers will potentially study cancer-free women who are at high-risk of breast cancer and have decided to undergo a bilateral mastectomy.
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Opportunities to Help Achieve Permanent Remission for Every Breast Cancer Patient
We have a variety of opportunities for our philanthropic partners to help advance personalized breast cancer treatment. We build a partnership between the MGM team and each donor to create a lasting impact on advancing breast cancer research and treatment. Philanthropy and naming opportunities include:
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- Tissue bank for efficient collection and storage of all breast cancer tumor samples
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The Molecular Pathology team conducts sophisticated molecular genetic pathology analysis of breast cancer specimens. Serving as the core facilities for translational molecular research programs and the extraction and storage of DNA and RNA, this team analyzes over 10,000 samples for the MGM program. This translational research program will undoubtedly lead to the improved understanding and cancer treatment of specific tumor types.
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What Is The Vaccine For Triple
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
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New Breast Cancer Vaccine Trial Underway At Cleveland Clinic
- 13 WREX Newsroom
Researcher conducts a breast cancer vaccine related experiment in a lab at Cleveland Clinic.
CLEVELAND Cleveland Clinic researchers have opened a novel study for a vaccine aimed at eventually preventing triple-negative breast cancer, the most aggressive and lethal form of the disease.
This phase I trial is designed to determine the maximum tolerated dose of the vaccine in patients with early-stage triple-negative breast cancer and to characterize and optimize the bodys immune response.
The U.S. Food and Drug Administration recently approved an investigational new drug application for the vaccine, which permits Cleveland Clinic and partner Anixa Biosciences, Inc. to start the study.
Despite representing only about 12-15% of all breast cancers, triple-negative breast cancer accounts for a disproportionately higher percentage of breast cancer deaths and has a higher rate of recurrence.
This form of breast cancer is twice as likely to occur in African-American women, and approximately 70% to 80% of the breast tumors that occur in women with mutations in the BRCA1 genes are triple-negative breast cancer.
The investigational vaccine targets a breast-specific lactation protein, -lactalbumin, which is no longer found post-lactation in normal, aging tissues but is present in the majority of triple-negative breast cancers.
The study is estimated to be completed in September 2022.
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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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?”
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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.”
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Cleveland Clinic Begins New Clinical Trial For Vaccine Aimed At Stopping Aggressive Breast Cancer
Dr. G. Thomas Budd of Cleveland Clinics Taussig Cancer Institute and principal investigator of the study, left, and Vincent Tuohy, Ph.D., the primary inventor of the vaccine and staff immunologist at Cleveland Clinics Lerner Research Institute, are part of a phase 1 study testing a proposed vaccine to prevent breast cancer.
CLEVELAND, Ohio Cleveland Clinic researchers have opened clinical trial for a vaccine that could prevent an aggressive form of breast cancer before it occurs, the Clinic announced Tuesday.
The proposed vaccine is aimed at potentially preventing triple-negative breast cancer, the most lethal form of the disease.
This day has been more than two decades in the making, Vincent Tuohy, the primary inventor of the vaccine and staff immunologist at Clinics Lerner Research Institute, said during a virtual press briefing Tuesday. Preclinical studies showed that a single vaccination could prevent breast tumors from occurring, and inhibit the growth of already existing breast tumors.
If the vaccine is successful, it has the potential to transform the way we control adult onset cancers, Tuohy said.
The Clinic is partnering with Anixa Biosciences, Inc., on the phase I trial to determine the maximum dose of the vaccine that is safe and effective in patients with early-stage triple-negative breast cancer.
The study, funded by the U.S. Department of Defense, is based on pre-clinical research led by Tuohy and originally published in Nature Medicine.
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Phase 1 Trial For Triple
Cleveland Clinic researchers along with Anixa Biosciences have initiateda phase 1 clinical trial to test a vaccine intended to prevent triple-negativebreast cancers . This trial is a first of itskind.
TNBCs are named so because they test negative for estrogen receptors,progesterone receptors, and excess HER2 protein. Since these are typicaltargets for breast cancer therapeutics, triple-negative breast cancers carry apoorer prognosis because fewer drugs can target them. TNBCs account for about10-15% of all breast cancers. As many are basal-type carcinomas with highergrades, TNBCs tend to be fast-spreading. Mastectomy is currently the onlyprevention measure available in those with high risk.
The vaccine is intended for use in post- or premenopausal women. Thevaccine targets -lactalbumin, a protein involved in milk production. Alpha-lactalbuminis normally expressed during lactation but is not found in ageing tissues post-lactation.Since most TNBCs overexpress the protein, a vaccine-primed immune system canidentify and attack emerging TNBC tumours. Given that no autoimmune inflammation hasbeen observed in preclinical trials, it is believed that healthy breast tissuewill be spared.
The clinical trial, funded by the U.S. Department of Defense, assessesthe maximum tolerated dose and evaluates immune responses to the vaccine. Trialparticipants will initially consist of 18-24 cancer-free individuals who havebeen treated for TNBC within the last three years.