Dr. McKee, Welcome! Let’s start out with your background. Where were you before joining GeoVax?
It's a bit of a shaggy dog story, but I'll abbreviate it as best I can! I obtained my M.D. from the University of Virginia School of Medicine, and a Master of Public Health degree from Johns Hopkins University School of Hygiene and Public Health in Baltimore, MD. I was initially trained as a pediatric infectious disease physician at Vanderbilt University School of Medicine, but I also did a residency in public health and preventive medicine and later became certified in tropical medicine as well. After my residency and fellowship, I joined the Army and spent most of my next 20 years at Fort Detrick in Frederick, MD, in biodefense research, with various leadership positions in virology, immunology, and preventive medicine.
I retired from the Army as a Colonel in 2001, after which I went on to serve as the State Epidemiologist in North Carolina. Then, in the fall of 2001, 9/11 happened and we had the anthrax attacks. I returned to work with the Department of Defense as a contractor, mostly working on their anthrax vaccine programs. I then joined a small vaccine developer in Maryland called DynPort Vaccine Company as the Senior Director of Clinical Research, then I moved to Quintiles, now called IQVIA. At Quintiles, I worked in a number of positions, including Vice President for Vaccines and Public Health in the Infectious Diseases and Vaccines Center of Excellence. I was there for more than 10 years. In 2017, I joined a midsize CRO called Pharm-Olam as their CMO, and I’d been working part-time doing consulting and contract work before joining GeoVax in January of this year.
And what was it about GeoVax that you found so enticing?
A number of things actually. I'd known about GeoVax for several years and had some interactions with them at the outset of the COVID pandemic. I was doing some work with a vaccine developer outside the U.S., and there was some talk about a collaboration. That’s when I became much more familiar with GeoVax’s MVA platform technology, which is the basis of its vaccine development effort.
During those initial talks, I got to know David Dodd and some of the team. I have a great deal of admiration and respect for the work that they were doing, specifically around the science that is the underlying platform. I started consulting with the company towards the end of 2021 when GeoVax in-licensed an investigational Covid vaccine from City of Hope National Medical Cancer and an immuno-oncology asset, Gedeptin® from PNP Therapeutics. The company was looking to enhance clinical development expertise on staff and to hire a CMO to fill both the registrational and regulatory roles, as well as lead the development strategy for these assets. And so, it looked like a very interesting opportunity, and one thing led to another and so here I am. I’m delighted to have joined GeoVax, especially at this most exciting time in its development.
Let’s start out talking about the Covid Vaccine program because that is still very much at the forefront of the headlines today. What is it about the GeoVax strategy that sets them apart from the handful of vaccines we have available today?
Yes, a number of things about the in-licensed COVID-19 vaccine and its platform are intriguing. First of all, it's a synthetically created version of MVA (“Modified Vaccinia Ankara”), which is a Modified Vaccinia, an attenuated Vaccinia, virus platform that offers a number of intriguing opportunities in terms of how genes that are inserted into that platform are delivered to the body, all of which are designed to stimulate and enhance the immune response.
But specifically, the Covid vaccine (“CM04S1”) that the Company in-licensed from City of Hope has two genes inserted into the MVA platform. One is the spike protein, which is the basis for most of the vaccines that are currently on the market or that are in late-stage development. And the City of Hope vaccine development team also inserted the gene for the nucleocapsid protein, which is one of the internal structural proteins of the virus. And this is important because, as you know, one of the bugaboos about the SARS-CoV-2 virus is its propensity to mutate and produce these variants of concern. It’s the spike protein that has the propensity to mutate, and that’s what allows the virus to evade the immune response stimulated by natural infections or the antibodies induced by the so-called “ancestral strain” or gen-1 versions of the virus, which is what the available vaccines were made from.
The nucleocapsid protein is a relatively stable protein from the standpoint of its genetic structure and doesn't vary very much across the various strains. And so, we think that the inclusion of this nucleocapsid protein into the vaccine construct provides the vaccine with the ability to provide a more broad-based and durable immune response, regardless of what happens to the virus as it mutates in nature. And so that's one aspect of differentiation and potential value of CM04S1.
The other aspect that we think is very important is the fact that the immune response to the internal proteins is primarily driven by the T-cell arm of the adaptive immune system. The spike protein stimulates both antibodies and T-cells, but the most important aspect of the spike protein immune response is the antibody response. And that's what's responsible for the protection that we're seeing with the current versions of the vaccine. But the T-cells are important not only for stimulating B-cells and the underlying antibody response, but they are also responsible for clearing the virus from infected cells. And so beyond protection with antibodies, we want to generate an active T-cell response to offer a further, more broad-based, type of protection. This is particularly important in patients with immunosuppressive diseases, such as hematologic malignancies, other cancers, some of the autoimmune diseases, and so forth, that are characterized by an inability to mount an effective antibody response. These are all high-risk populations, and we think a predominantly T-cell-driven response from our vaccine can offer these patients a unique opportunity to be protected, whereas the currently available spike protein-based vaccines aren't able to offer that degree of protection.
What about the rest of the infectious disease pipeline? There are many areas where you bring decades of expertise in hemorrhagic fevers and tropical diseases.
It's really funny, because where I cut my teeth in basic and translational science during my time with the Army at Fort Detrick, Maryland, was on viral hemorrhagic fevers: vaccine development, and antiviral drug research. And so when I first became familiar with GeoVax's platform and technology, because as you noted, they've developed candidate vaccines against Marburg, Ebola Zaire, Ebola, Sudan…, Lassa ….some of the really nasty viral hemorrhagic fevers. my interest was definitely piqued on an intellectual level.
And while none of these vaccines have transitioned to the clinic yet, we are still fine-tuning them, if you will, the data that's emerging to date, particularly with the filovirus vaccines, the Marburg and Ebola virus vaccines, is very, very promising. And I think we're likely to see one or more of those vaccine candidates transition to the clinic before too much longer. So that’s tremendously exciting.
And on the newly acquired oncology programs?
Well, this is also an interesting story. Gedeptin is a version of a gene therapy type approach to cancer therapeutics. And what it is basically is a genetically engineered virus that activates an otherwise inactive chemotherapy drug to kill cancer cells. And so, the idea here is the creation of an adenovirus carrying the gene that codes for a phosphorylase protein that is injected into tumor masses in patients with advanced head and neck cancer. Patients are then infused with the chemotherapeutic agent, which is fludarabine. And the fludarabine is converted by this bacterial phosphorylase into an active form of the drug that kills the tumor cells that have been infected with this modified virus. And so, it's a very locally administered therapy, designed to shrink tumors and hopefully provide some additional months or years of life to people who have no other option for therapy.
Any final thoughts?
Well, I mean, I think the excellence of the executive leadership speaks for itself. I mean, David is highly experienced and just a terrific Chief Executive Officer and a terrific person to work for and with. The Chief Financial Officer, Mark Reynolds, is just a wonderful colleague to work with as well. The Chief Scientific Officer, Mark Newman, actually came into the company not too terribly long before I did, but he brings to the organization a very, very deep experience with T-cell immunology. And between that and his virology expertise, I think he's leading the science charge for the organization as well as anybody that I can think of. And then the team of scientists behind him is terrific as well. Our Chief Business Officer, John Sharkey, brings a ton of experience and scientific insight into new and existing business relationships, and I have a Head of Clinical Operations that we brought on board shortly after I joined the company named Erica Raiden, who is a terrific colleague- in-arms as we wrestle with getting these clinical trials underway and moving forward. And so long story short, it's a small but very efficient and effective team that I think is driving this company exactly the way it needs to go.
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing human vaccines and immunotherapies against infectious diseases and cancer using novel proprietary platforms. GeoVax’s product pipeline includes two ongoing Phase 2 clinical trials of GEO-CM04S1 (formerly COH04S1) for COVID-19 as a universal booster vaccine to mRNA vaccines authorized by the U.S. Food and Drug Administration (FDA) and as a primary vaccine for use in immunocompromised patients. In addition to GEO-CM04S1 for COVID-19, GeoVax is developing GEO-CM02 as a pan-coronavirus vaccine. The Company is also conducting a Phase 1/2 clinical trial of Gedeptin® for treatment of head and neck cancer. Gedeptin® has been granted orphan drug status by the FDA. Additional research and development programs include preventive vaccines against Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa) and malaria, as well as immunotherapies for multiple solid tumors. The Company’s portfolio of wholly owned, co-owned, and in-licensed intellectual property stands at over 70 granted or pending patent applications spread over 20 patent families.
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventive vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventive vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventive vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventive vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
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