“BRAKES FOR BREASTS” ANNIVERSARY
1)PROGRESS OF THE VACCINE OVER THE PAST 10 YEARS
In May, 2010, I published a manuscript in a very prestigious journal called Nature Medicine. The manuscript provided details of a vaccine created in my laboratory and designed to prevent breast cancer. The publication attracted an enormous amount of global media attention, and I was suddenly immersed in media notoriety with numerous interviews about my discovery. This attention was all very unexpected but turned out to be very productive in the sense that it attracted the attention of Leigh Anne Best and Laura Frank. These women had been working hard to raise money for breast cancer but were not happy with conventional breast cancer organizations that were very demanding and used much of their raised money for administrative costs. Leigh Anne and Laura heard about my efforts in developing a novel vaccine designed to prevent breast cancer and found out that 100% of any money that they raised would go directly into my research program with none of the donations going toward any administrative costs. Leigh Anne and Laura found this feature to be very attractive and they subsequently contacted me. The rest is history. In their first year, Leigh Anne and Laura and their Brakes for Breasts program raised about $10,000 from a handful of automotive maintenance shops in the Cleveland metropolitan area. Every year since 2010, Leigh Anne and Laura found a way to raise increasing amounts of money for my program from more and more shops across the nation and even Canada. Their efforts saved my program and kept my research going through many lean years that included being turned down by over 17 grant applications and experiencing a failed business venture. Honestly, I would have had to shut down my research program long ago if it were not for the sustaining yearly support from Brakes for Breasts. Fortunately, in 2016, the Department of Defense requested applications for projects focused on preventing breast cancer because military families have a higher incidence of this disease compared to the general American population. I saw this as a rare opportunity to apply for such focused funding, and I immediately submitted my application for this money by partnering with my colleague G. Thomas Budd, M.D., a breast cancer oncologist at the Cleveland Clinic. We were successful in receiving a four-year award starting November 1, 2017 that provided me with $2.2 million in direct funds for manufacturing the human vaccine and performing toxicology studies to determine its safety in animals. In addition, the award provided Dr. Budd with $1.8 million in direct funds for performing two phase I clinical trials designed to determine the safety of the vaccine in human subjects and the dosage needed to achieve a vibrant anti-tumor immune response. The phase Ia safety and dosage trial will be performed on human subjects recently diagnosed with triple negative breast cancer (TNBC), the most lethal form of breast cancer. The second phase Ib safety and dosage trial will be on human subjects at high risk for developing TNBC who voluntarily elect mastectomy to reduce their risk. We plan to vaccinate these subjects prior to mastectomy and then examine their removed breasts for any inflammatory damage that the vaccine may cause to ensure safety of our vaccine in healthy, cancer-free women.
2)CURRENT STATUS OF THE VACCINE
There are two major components of the TNBC vaccine: 1) the target protein, namely, human α-lactalbumin. This is the specific protein against which we plan to induce a well-defined immune response associated with inhibition and prevention of breast cancer growth; and 2) the “adjuvant”, an inflammatory substance that non-specifically irritates and activates what is called the innate immune system that orchestrates the defined specific response to the α-lactalbumin target protein. Both of these components must be made under very detailed and controlled conditions and must meet the very complex analytic requirements of the US Food and Drug Administration (FDA). This analytic process is called Good Manufacturing Practice (GMP). It may sound like a benign name for a manufacturing process, but it is well-known to represent an extremely complicated process that requires a fastidious attention to details that will convince the FDA that our reagents can be produced in a repeatable manner with no chance of containing contaminants that may harm humans injected with the substance. This GMP manufacturing process is extremely expensive and requires specialized facilities specifically dedicated to this effort. Our human α-lactalbumin was made under GMP conditions by a company in California at a cost of approximately $850k. The adjuvant is being manufactured in a GMP facility in Switzerland at a cost of approximately $750k. However, after GMP manufacturing of our adjuvant, we will have additional expenses for performing sterility studies as well as fill and finish studies in vials for use in clinical trials. I anticipate that these costs will exceed $300k. There are several other additional costs related to preclinical toxicology studies and prolonged stability studies that will easily consume the remainder of the $2.2 million allocated from our Department of Defense grant for preparing the vaccine for our clinical trials.
A few months ago, I was hoping that these GMP products would be ready in time for us to apply to the FDA for permission to start recruiting for our phase Ia clinical trial by the fall of 2020. However, the human race has since been stalked by the SARS-COV-2 virus that has caused the current COVID-19 pandemic. This pandemic has caused unanticipated issues that will likely delay recruitment of test subjects until the first quarter of 2021. While we are waiting for completion of all regulatory requirements, we are currently assembling our application to the FDA to obtain permission to use our Investigational New Drug (IND) in clinical trials.
I have provided only the core basic things that must be done to get permission from the FDA to test our vaccine in human subjects. I simply want to give you an idea how complicated this process is and why it takes so long and costs so much. Meanwhile, when travel becomes acceptable again, I am hoping to attend appropriate meetings to inform the medical research community about what we are doing. In addition, we have submitted several grants for supporting our lab work and have submitted several patent applications to obtain sufficient intellectual property (IP) protection to attract commercial licensing partners from the pharmaceutical/biotech industry. The latter is necessary to provide a licensing partner with a monopoly to develop and test our vaccines in very expensive advanced phase II/III clinical trials to determine whether our vaccine is effective in inhibiting the growth and emergence of breast tumors and whether it has potential for commercialization. Without the expensive IP in the form of several patents that cover all industrialized countries, our vaccines would be in the public domain without any possibility of receiving interest from the pharmaceutical/biotech industry. Basically, it would be dead and finished. Thus, strong IP is an essential but costly part of our overall effort to provide the general public with our vaccine. The expenses for patent protection have been absorbed by the Cleveland Clinic. Our strong IP has worked since we formed a strategic alliance and licensing arrangement with Anixa Biosciences, Inc. (ANIX) on July 17, 2019 (https://www.crainscleveland.com/health-care/anixa-biosciences-cleveland-clinic-enter-license-agreement-breast-cancer-vaccine). This arrangement will provide us with access to investor money needed to finance our very expensive phase II/III clinical trials. I must emphasize that this licensing agreement provided absolutely no money or other assets to me or to my research program.
In addition to all of the ongoing efforts to move our TNBC vaccine through the FDA regulatory process, we are finishing the preclinical testing of our preventive ovarian cancer vaccine. This vaccine, like the TNBC vaccine, can also be used effectively to treat established growing ovarian tumors and will have to go through two phase I trials similar to the clinical plan we have for our TNBC vaccine. Currently, I have no funding for these clinical trials and am actively seeking such funding.
Finally, I would like to inform you that I must rely on philanthropy for paying the modest salaries of the laboratory and regulatory personnel involved in getting our vaccine ready for clinical trials. These salaries were not included in the DoD grant because of the limits the DoD provided for funding this project. I would greatly appreciate continued support from Brakes for Breasts to cover all of the unfunded expenses involved in our very expensive clinical trials designed ultimately to prevent TNBC and ovarian cancer and thereby profoundly alter the natural history of these lethal diseases.
3)QUOTE ON THE IMPORTANCE OF THE FUNDS RAISED
“We are on the verge of testing our breast cancer vaccine in clinical trials, and philanthropy has been the foundation of this progress. Without the extensive and generous support I have received from Brakes for Breasts, I would have had to end my research on immune prevention of breast cancer several years ago. My entire team believes that we are doing transformative work that has the potential to dramatically change the way we control breast cancer. I think it will all be very worthwhile, and I look forward to a great celebration together.”
Vincent K. Tuohy, Ph.D.
Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research Staff,
Dept. of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Professor,
Dept. of Molecular Medicine, Lerner College of Medicine of CWRU
Email: [email protected]; Cell: 216-213-8734
Information About the Breast Cancer Vaccine Research Program
Dr. Vincent Tuohy
In Spring 2017, Dr. Tuohy’s research program was awarded funding to launch a greatly anticipated clinical trial to begin testing the vaccine. The goals of this trial will be to determine proper dosage as well as safety parameters of the vaccine including risks and side effects; however, there are a few critical steps the team must accomplish to achieve regulatory compliance necessary for human testing. Prior to clinical trials, the Federal Drug Administration (FDA) requires that the investigational new drug (IND) must meet stringent criteria for use in humans. This is done to ensure that the components of the IND are properly made in a reproducible manner and is well defined, pure, and free from contaminants that could harm test subjects. From start to finish, this process is costly (~$1.5-2M) and requires specialized, offsite facilities dedicated to this effort. After this is complete, the team will submit an application to the FDA to obtain permission to use the IND in clinical trials. The first Phase I trial, slated to begin in mid 2020, will focus exclusively on women who have recently recovered from treatment for triple-negative breast cancer, the most lethal form of this disease. If this trial indicates that the vaccine has an acceptable safety profile, it will be followed by a second Phase I trial, which will be open to women at high risk for triple-negative breast cancer who elect voluntary mastectomy to reduce their risk. Dr. Tuohy’s team plans to vaccinate them a few months prior to their planned mastectomy and then examine the removed breast tissues for any inflammation that the vaccine may induce. Once Dr. Tuohy and his team have determined the vaccine is safe in humans, they can begin to vaccinate cancer-free women.
Dr. Tuohy and his team are incredibly grateful for the passion and advocacy behind this important research initiative. Funding enables the team to expand and accelerate their research goals. We look forward to a world that provides pre-emptive immunity against breast cancer. We can make a difference together.
September 2017 IdeaStream Panel Discussion – A Must View! Click Here to Watch Dr. Tuohy and other distinguished Professionals from the Medical Industry
Recent Articles Regarding the Breast Cancer Vaccine and Brakes for Breasts:
2014 Article in Tire Review Magazine
2014 February Tuohy Currents Magazine Article
The Team That Wants To Eliminate Breast Cancer
Brakes for Breasts Initiative Article - Shop Owner Magazine October 2018 Article