A Word from Dr. Tuohy

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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. 

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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.

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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. 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. 

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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.