Monday, April 19, 2021 1:21:16 PM
Interview conducted by:
Lynn Fosse, Senior Editor
CEOCFO Magazine
Published – December 7, 2020
CEOCFO: What is your funding position? Development and eventually commercialization are very expensive.
Mr. Cotropia: Yes, that is a very relevant question. We will be securing long term financing for advancing our technology. We have begun the process of producing variants of our existing anti-HIV monoclonal antibodies and identifying target site on the CoronaVirus for producing multiple antibodies against that virus. We are extending our lab capabilities on the Texas A&M University campus at its Institute for Pre-clinical Studies where we will be producing both addition monoclonal antibodies against HIV and the against the CoronaVirus. For HIV, we will be combining the anti-HIV neutralizing antibodies with the anti-HIV peptide—which is also immunomodulating—that has been previously clinically tested by Enzolytics to have beneficial effect in HIV patients. The funding we arrange will take us through that development which will include animal trials to be followed by human clinical trials of these therapeutics.
[b[color=green]]Success in these steps will bring the necessary funding for success. Demonstrating positive results will translate into the necessary funding due to the dire need for these therapies.[/color] As I mentioned, there is not going to be one bullet that fends off either the HIV virus or the CoronaVirus. It will be necessary to have more than one. We welcome Eli Lilly and Regeneron in their initial antibody production and that success is all to be rewarded and celebrated. However, as we have seen in the past with HIV, it is going to be a very difficult to completely control the CoronaVirus and all of its mutated forms. Success will require multiple therapeutics and we know that monoclonal antibodies will certainly be in the picture and in the front line of successful treatments.
Another important aspect of our technology is that identification of a neutralizable binding site on the virus can lead to the creation of a vaccine – one that would be of a different format from the current mRNA vaccines now being produced. Specifically, the vaccine would be based on the known broadly neutralizing antibody and the highly conserved binding site to produce an active immunization that would not comprise nor incorporate an immunization process using nucleic acid constructs. In this process, a protective active immunization would use the neutralizable binding site on the virus as subunit peptide vaccine. Use of peptide sub-unit immunogens in active immunization obviates the concerns for weak humoral immune response, theoretical risks of insertional mutagenesis, and provocation of an autoimmune response, in other words, concerns associated with immune response outcomes that are related to DNA and mRNA vaccination.
Therefore, different vaccines may be produced in very different ways, some of which hopefully will be very effective and very safe as to their long-term effect on the human body. A safe vaccine can be expected, based on a subunit peptide vaccine formulation using the neutralizable bind site on the virus in its development.
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