$BVAXF Unique Value-Added Antiviral Vaccine Technology Platform
https://stockhouse.com/opinion/interviews/202...y-platform
Founded in 2018 to improve on protein haptenization and leverage previous vaccine development in the field, Vancouver, BC-based BioVaxys Technology Corp. (CSE.BIOV, OTCQB: BVAX, Forum) is a clinical stage biotechnology company that’s developing viral and oncology vaccine platforms, as well as immuno-diagnostics forClick to enlarge SARS-CoV-2.
Stockhouse Media’s Dave Jackson was joined by company CEO James Passin and CMO Dr. David Berd to get investors up to date on the fascinating company and the unique biotech investment opportunity provided.
SH: To start off with, can you tell us a little bit about yourselves and the history of the company?
James: Absolutely. I don't come from a scientific or medical background. I was a 20 year hedge fund manager based in New York. I managed a billion-dollar equity portfolio, but I was an active investor in biotechnology and life sciences over that 20-year period, directing over $250 million of investment into biotechnology. It was really that during that tenure, before I retired from the hedge fund industry, that I came to meet Dr. David Berd and become almost a religious believer in the value of Dr. David Berd's technology. And we got together to launch by BioVaxys in order to really finished clinical development and also commercialization of Dr. Berd's technology.
SH: Can you update our investor audience and your BioVaxys shareholders on any new company developments, especially in the wake of COVID-19?
Dr. Berd: So I'm a physician, I'm a medical oncologist by training and spent my entire career on cancer immunotherapy, particularly cancer vaccines, and I'm the inventor of a novel cancer vaccine technology, which involves what we call haptenization, which we can discuss in detail in a few minutes. We realized, when faced with the COVID-19 epidemic last year, that the technology could easily be applied to viral vaccines as well as cancer vaccines. That is the basis of our work in virology. The COVID vaccine that we have developed is conceptually very complicated, but technically, very simple. We use one of the viral proteins called the spike protein, which many other companies are focused on because developing an immune response to that is very important, if you want to prevent the disease. We increase the immunogenicity as we call it, or basically increase the chance of the body making a strong response to it by something that we call ‘hapten modification’.
Haptenization is an immunological concept. It is very old, it was discovered about a hundred years ago, it is in immunology textbooks. But it hasn't been extensively applied to medical problems, which is what we have been doing in cancer and in COVID. A hapten is a chemical, a very simple chemical, and there are many of them, there are thousands of chemicals out there that would service haptens, but one that we have chosen to work with for a variety of reasons. When you hook a hapten up to a protein, you tremendously increase the ability of the body, whether it is a mouse or a human to respond to that protein. Not only that, in some cases, a protein which doesn't induce any kind of an immune response can be made to induce a response by haptenizing. The mechanism, this has been worked out, it has been worked on over many years and it's, it's understood down to the level of the cells.
We know that when you have to haptenize the protein and inject it properly, you get a strong immune response, not only to the haptenized protein, which of course is not what you are interested in, but to the original, unmodified protein, which is what you are interested in. You get two kinds of responses - one, you get an antibody response against the protein. Most of the people listening to this will know about antibodies because they are in the news all the time. But just as important or perhaps more importantly, you get a response from the other side of the immune system, which is called the T-cell mediated response. And although this is critically important, it doesn't make the news too much. It is a little bit more difficult to explain and much more difficult to measure which, which we will talk about more when we talk about our diagnostic. So you get an antibody response and a T-cell response. We believe that both are critically important in in helping people fight off or prevent severe infection or any infection at all with the virus that causes COVID-19.
SH: You just closed the second tranche of tranche of a non-brokered private placement to raise over two-million dollars Canadian in gross proceeds. Can you expand on this initiative for our investor audience?
James: The purpose of the recent successful fundraising was to replenish our working capital and really provide the balance sheet to enable the continued, successful, clinical, and commercial development of our various products. For example, we continue to move forward with the preparatory work for our phase one, ovarian cancer therapeutic vaccine trial, which will be done by our partner, ProCare Health Iberia, which is a large private pharma company based in Spain. It was a spin-out of Procter and Gamble. It is a large European biotechnology and pharma company focused on women's healthcare. We have partnered with ProCare Health on our ovarian cancer therapeutic vaccine, and our manufacturing partner, which is called Bio Elpida based in Lyon, France is beginning a preparatory work. We are working on that and we continue to also develop our COVID related products.
One of which is COVID DTH, which Dr. Berd alluded to, which very simply in that it is a skin test for T-cell immunity to COVID. Really the relevance is there's no way of that is economic or available commercially to do large-scale T-cell screening. It is very easy to do antibody screening. It is very easy to do PCR tests or other tests to see people are infected, but there is no practical or economic way to do T-cell screening. T-cell immunity is the most durable arm of the adaptive immune system, it is based on peer reviewed studies and data that has been published. In authoritative publications, it's very clear that that the T-cell immunity is really the key to getting over the pandemic. T-cell immunity tends to be more cross-reactive with different variants, at least based on case studies with other viruses and when T-cells are analyzed, it is clear that people that recover from COVID genuinely have strong T-cell immunity. What we want to do is to bring T-cell screening as an additional tool on top of antibody screening and PCR tests, and other types of screening.
SH: Can you tell us more about CoviDTH – your immuno-diagnostics tool? Sounds fascinating! This sounds like something that needs to be available right now. When will you expect to be filing your IND?
James: BioVaxys recently received a written response from the FDA to our questions regarding our planned IND submission later this year for CoviDTH. I'm very happy to report that the letter was quite positive and, effectively, our planned IND submission was effectively green-lit. We have already begun the work of preparing the IND and effectively our expectation is that we will submit the IND and hopefully, subject to FDA approval, we will be able to commence a combined phase one and phase two trial for, for CoviDTH. Again, CoviDTH is a diagnostic, it is effectively a skin test for T-cell immunity to COVID using a very well-known and widely used screening tool called delayed-type hypersensitivity.
We control the IP for using this for COVID with the spike protein that Dr. Berd mentioned earlier. I will mention that our scientific advisor Dr. Barrios from the Canary Islands (Spain) successfully completed two human trials with a very similar technology to CoviDTH and her findings were recently published in a prestigious periodical. With the very encouraging safety and efficacy data from her study really that is very encouraging for our plan, our planned Phase One/Two study.
SH: In the intro, I mentioned the SARS-CoV-2 and cancer vaccine platforms in development. Can you unpack the benefits of these vaccines?
James: In terms of COVID, there are COVID vaccines that have been, either fully approved or have emergency use authorization or similar authorizations around the world. One thing that's interesting about our vaccine is that we believe that, and the database center animal studies shows, that it produces a very robust T-cell response, which is very important in terms of helping to confer immunity against COVID. We are planning to do a study soon, to demonstrate our view that the haptenized spike protein has less ability to bind to the ACE2 receptor and theoretically, this could reduce the rare side effects and toxicities that are observed - albeit quite rare with the other vaccines that approach the spike protein. We will be announcing something on this shortly.
In terms of cancer, really our haptenized therapeutic cancer technology offers the potential for late stage cancer patients to really utilize their own immune system, to mount a T-cell response against cancer. I am very excited to continue the work that Dr. Berd started with his approach. David, from your perspective what, what do you see as the unique attributes of our cancer vaccine platform?
Dr. Berd: There are two important attributes. One is that we are immunizing people with their own cancer cells. In the old days, we call this autologous, but nowadays people call this personalized therapy, which is an easier concept to understand. There is a lot of reasons to think that even for the same type of cancer, that the cancer in one person is chemically, in a subtle manner, different from the cancer and in another person, so that if you want to immunize people, the best thing to do is to use their own tumor cells. Point one is we have a personalized or technically a what we call autologous vaccine. The second thing is we use the haptenization. It has been known for a very long time, too long, that just trying to immunize people with their own cancer cells is really hard and if it had been easy, the cancer problem would have been solved 30, 40 years ago.
Many people have tried it. The reason it is hard is, that cancer cells, to the immune system, look very similar to normal cells. When you inject the cells into somebody, the immune response generally doesn't recognize the cells as being foreign and doesn't make a response against it. As I alluded to a little bit earlier, when you put a hapten on the cells, you haptenize many proteins on the cell. Some of these are cancer antigens to which the body can respond, and you get a response to cancer antigens, which otherwise are invisible to the immune system, which leads to a much more robust response. We have data from some of the precursor technologies that we've worked with to indicate that this can result in meaningful anti-cancer effects.
SH: Why is their such a need for a new therapeutic option for ovarian cancer?
James: Ovarian cancer is a huge unmet medical need. Unfortunately recent innovations in cancer therapeutics and cancer immunotherapy like checkpoint antibodies, for various reasons do not provide really, unfortunately, enough of a benefit, especially for late stage ovarian cancer patients. We are quite proud that we have partnered with the World Ovarian Cancer Coalition, which is a non-profit, patient advocacy organization. Really, it is quite clear based on our communication with the community, that the world is screaming for new ovarian cancer therapeutics. David, and maybe just quickly in terms of ovarian cancer specifically, what is your view on really what we can offer and why this is our lead product?
Dr. Berd: Yes, the major breakthroughs in ovarian cancer, which were essentially developing effective chemotherapy were in the 1970s, and these were very important advances, but that was a long time ago. Most people present with advanced ovarian cancer, early detection has proven to be impossible so far. If you give chemotherapy, which was developed 50 years ago, you can cure about 25% of the patients, which is great, but at least for the other 75% who are not cured and who will eventually succumb to their cancer, there are many treatments, particularly traditional treatments like chemotherapy, which can help these people, but there are no curative treatments. Immunotherapy, for instance like our haptenized vaccine has, first of all, there is a great opportunity for it, the side effects we expect will be much less than chemotherapy. Based on previous work that was done we believe that it has the capacity to increase the survival of people with advanced ovarian cancer.
SH: Have you obtained any clinical data for your ovarian cancer vaccine?
James: Yes, David did work previously with the haptenized autologous ovarian cancer vaccine. In fact, there was a successfully completed phase two trial with excellent data. Now, BioVaxys has improved the formulation, so to speak and I'll leave David to get into the details. Effectively, we are starting again with phase one because of these improvements, but it is not radically different from what David was doing before.
Dr. Berd: The previous work was done with a hapten called DNP, which we modified the cells just with the DNP. These studies were done by me when I worked at Thomas Jefferson University and also by company that was a precursor to BioVaxys and in a small number of patients - I guess a total of about 50 patients were treated. We established that the treatment was very safe with very little side effects and that the clinical effects looked very promising, and the survivals appeared to be much longer than one would expect with traditional treatments. Of course, these were not phase three comparative trials, but in single arm trials. When BioVaxys was started, we decided that we needed to make sure the vaccine was up to date.
I had already done some work on what we call, a bi-haptenized vaccine, which is modified with two haptens. It sounds trivial but is not because the two haptens we use are immunochemically distinct and they modify or stick onto different parts of proteins. Therefore, you get a much greater modification of tumor antigens and theoretically a much more potent immunological response. We decided that since we were starting a new company, we would start with a new and improved technology. We expect that the results of the bi-haptenized vaccine will be at least as good as what we saw previously with the old one. We have a lot of reason to think that actually the results will be better. We have not yet done any clinical trials, but we expect to start a phase one/two trial as James alluded to in Europe next year.
SH: The Company looks set for strong growth in 2021. How are you placed to expand operations?
James: As I mentioned earlier, our partner in France is ramping up the work to begin the production of the ovarian cancer vaccine. What is very exciting is that our partner Bio Elpida has a dedicated manufacturing facility in France. Our view is that that this really would allow us to expand. As we move, for example, into other cancers it will be great having this dedicated facility. That is a really important breakthrough for us. In addition, we have just established an office in Ontario, Canada where we're taking advantage of the deep life science industry there to begin work on some of our COVID related products. Stay tuned, but I think we will see significant development of our infrastructure and supporting our various projects in the coming six months.
Dr. Berd: The haptenized cancer vaccine technology is a platform technology, and it is theoretically applicable to many other cancers. With the old technology, we not only worked on ovarian cancer, we worked on melanoma and there were hundreds of patients treated with, again in single arm trials, not in controlled trials, but with excellent results that were published in first rate journals. There already is data in melanoma and ovarian, and we are starting with ovarian because there's such a great need for a treatment, that we think that success in ovarian would lead to clinical trials in multiple other cancers.
SH: For company shareholders and potential investors, what kind of future clinical-stage development and progress can we expect for your vaccines moving forward?
James: As we mentioned earlier, we are going to launch the phase one ovarian cancer trial next year. We are expecting to launch the phase one/two trial for CoviDTH once we have the approval of the IND. In addition, I should mention that as part of the collaboration partnership between BioVaxys and ProCare Health Iberia, BioVaxys has the right of first refusal to market a product called Papliocare, which is the first device for treating HPV dependent, cervical lesions, which is a huge problem around the world for women. Papliocare is approved in the European union. It is already on the market as an over-the-counter product you can look it up and it is a significant revenue generator in Europe. It is for the FDA to review, and depending on how it goes with the FDA, if Papliocare is approved in the United States, we intend to exercise our right of first refusal to market Papliocare, and that is going to be great because that means we could be generating revenue next year from an approved product.
SH: What separates BioVaxys from the competition and makes your business model unique?
James: I'll hand it over to Dr. Berd to discuss on the technology side, but in terms of the investment side - in terms of the previous work that was done, not by our company, but by other companies in the university that the Dr. Bird was associated with, the cumulative investment in our cancer vaccine technology is probably in excess of US$130 million. There has been significant investment. There have been over 500 human volunteers that have been vaccinated with the haptenized cancer vaccine that Dr. Berd developed in FDA approved trials. In terms of the technology, there is a lot of skin in the game. In my view, that really sets us apart from other companies. Then in terms of business development, between CoviDTH as well as Papliocare, I think we are a lot closer to revenue than the market is understanding. And then on, on the technology side, we are the world leader in haptenized vaccine research. Just to wrap it up, David, if you could discuss what is unique about our company from your perspective?
What has become interesting to me is that we are taking one immunological phenomenon, which is the kind of esoteric to people and probably to most investors, which is this concept of haptenization, and we're applying it to two very different diseases - one cancer, two viral diseases. By the way, we think that the work that we're, that we are doing with COVID-19 is, there is absolutely no reason why it is not applicable to other viruses. For example, there is a big need for improvement in the vaccines for influenza which have been on the market for many years, which are not as effective as we would like them to be. That is an area that we could go into. It is interesting to me, and I think unique, or at least unusual that we are taking one scientific phenomenon and applying it to two very different kinds of human diseases.
SH: I have to mention your stock has been on a bit of a roller coaster ride over the past 12 months. What can you tell our investor audience regarding the current valuation of your stock and why you think it’s a good buy right now?
James: I will preface that my response, with the observation that biotech is extraordinarily volatile. It is a very high risk, high reward industry, and that is true for every small cap biotechnology stock. We, and if you speak to any CEO, they're going to tell you their company is undervalued. When you look at our peer group and by which, I mean on the cancer side, companies that are pre-revenue, that clinical stage developing novel cancer related technologies, they have market caps or enterprise values that are multiples of the invested capital, the cumulative research and development costs that went into developing the technology and we are trading at a fraction of that cost. That is a very interesting metric.
You can look at a very successful large company listed on NASDAQ, Adaptive Biotechnologies - Adaptive have developed a T-cell test for COVID and had probably a billion dollar lift to its market capitalization, related to developing that product. That T-cell test requires a blood draw, and it is still extraordinarily expensive in my view where it is just not going to be commercial. Just that one product, CoviDTH, really could mean a massive multiplier for our market capitalization. I think when the COVID vaccines that, that did get emergency use authorizations came out, maybe there was some negative sentiment towards their COVID vaccine, but, I just need to remind shareholders that we are a very broad company that, and I would say that our main focus is on cancer.
We do have an outstanding COVID vaccine candidate. We do have a very exciting CoviDTH - our skin tests for T-cell immunity to COVID. I think we are well positioned to benefit from the continued pandemic, but our story is much larger than that. As we get closer to exercising our marketing rights for Papliocare, that that alone could support a significantly higher valuation than where we are trading. If you look at the SETI records, when I've been allowed by my lawyers, I've been buying the stock in the market, I've been participating personally in the private placements. I am a huge believer and I intend to add to my shareholding when the opportunity is lawful.
SH: What’s the long-term strategy for the company moving into 2021 and beyond, and what should retail and institutional investors be looking out for?
James: It is very interesting if you look at the number of transactions in the oncology space globally, this really has been one of the hottest areas in life sciences. I think as BioVaxys gets further down the road in clinical development, I would not be surprised to see that there would be strategic, big pharma or financial interests in our company. We want to position BioVaxys to be become, frankly, an acquisition target, but I think it is to early for that. Oncology space, there is a lot of money available, there is huge need and demand for novel therapeutics and therapeutic vaccines. I think we're very well positioned to benefit from that consolidation.
SH: Can you tell our audience a little bit about your corporate management and board teams, along with the experience and innovative ideas they bring to the biopharma space?
James: I mentioned on our board we are very lucky to have David Wang, who is a seasoned biotechnology, pharmaceutical and medical device entrepreneur, and senior executive. He has had very high-level positions, in particular, in large Chinese and Japanese biotechnology and biomedical companies. He has a lot of business experience and contacts, and it is great to have him on the board. In terms of our scientific and advisory panel, at least from my perspective, it’s quite impressive. On the policy side, we have a policy advisor, Professor Adam Coots, who is an expert in really in global health crises and very plugged into various multilateral, public health authorities that are potentially providing a lot of very useful feedback, and scientific information in terms of our COVID related products. David if you could just discuss some of our scientific advisors on the cancer side and the virus side.
Dr. Berd: On the cancer side, we have been lucky enough to acquire the services of Dr. Charles Dunton, who is a gynecologic oncologist, was formerly Professor of Medicine at Jefferson, who was quite well known for doing clinical trials in ovarian cancer. He actually was one of the first people I worked with, when we worked on ovarian cancer vaccines a number of years ago. He is not only knowledgeable, but he is very well connected, which is very, very helpful for a company like ours. James already mentioned Dr. Barrios, who was someone, who was basically a stroke of luck that we found each other, but you really could not do any better than somebody who is already working with the technology that you want to develop. That is of tremendous value to us. We have two basic virology consultants, who are basic scientists working in the virology area who we can turn to, which is very important when there are new developments in virology that maybe are a little bit beyond my expertise who can explain them to us and put them in perspective. We have got an excellent team of people who compliment the three full-time people in the company and will be very important as we move forward.
James: I would be remiss to mention, to fail to mention, we have a business development advisor, Shmuel Farhi, who is a legendary billionaire real estate developer based in Ontario. More importantly than that, he is a very significant investor in the Canadian, American, and Israeli biotechnology industries. One of our largest shareholders. He has a team of very impressive scientific advisors predominantly based in Israel. I say we get excellent business development advice from Mr. Farhi.
SH: And finally, gentlemen, if there’s anything I’ve overlooked please feel free to elaborate.
James: I think you have touched on all the material and important points with BioVaxys. so we are, we're grateful for your attention and really enjoyed discussing the company with you.
Dr. Berd: The only thing that I would add, is because we have been working on the technology for a long time, there is a vast amount of published peer reviewed literature, that is available, that forms the scientific background of what we are doing. Many investors are interested in this kind of thing, and we certainly are more than happy to supply it. We think that it is impressive and very supportive of what we are going to do in the future.
https://stockhouse.com/opinion/interviews/202...y-platform
Founded in 2018 to improve on protein haptenization and leverage previous vaccine development in the field, Vancouver, BC-based BioVaxys Technology Corp. (CSE.BIOV, OTCQB: BVAX, Forum) is a clinical stage biotechnology company that’s developing viral and oncology vaccine platforms, as well as immuno-diagnostics forClick to enlarge SARS-CoV-2.
Stockhouse Media’s Dave Jackson was joined by company CEO James Passin and CMO Dr. David Berd to get investors up to date on the fascinating company and the unique biotech investment opportunity provided.
SH: To start off with, can you tell us a little bit about yourselves and the history of the company?
James: Absolutely. I don't come from a scientific or medical background. I was a 20 year hedge fund manager based in New York. I managed a billion-dollar equity portfolio, but I was an active investor in biotechnology and life sciences over that 20-year period, directing over $250 million of investment into biotechnology. It was really that during that tenure, before I retired from the hedge fund industry, that I came to meet Dr. David Berd and become almost a religious believer in the value of Dr. David Berd's technology. And we got together to launch by BioVaxys in order to really finished clinical development and also commercialization of Dr. Berd's technology.
SH: Can you update our investor audience and your BioVaxys shareholders on any new company developments, especially in the wake of COVID-19?
Dr. Berd: So I'm a physician, I'm a medical oncologist by training and spent my entire career on cancer immunotherapy, particularly cancer vaccines, and I'm the inventor of a novel cancer vaccine technology, which involves what we call haptenization, which we can discuss in detail in a few minutes. We realized, when faced with the COVID-19 epidemic last year, that the technology could easily be applied to viral vaccines as well as cancer vaccines. That is the basis of our work in virology. The COVID vaccine that we have developed is conceptually very complicated, but technically, very simple. We use one of the viral proteins called the spike protein, which many other companies are focused on because developing an immune response to that is very important, if you want to prevent the disease. We increase the immunogenicity as we call it, or basically increase the chance of the body making a strong response to it by something that we call ‘hapten modification’.
Haptenization is an immunological concept. It is very old, it was discovered about a hundred years ago, it is in immunology textbooks. But it hasn't been extensively applied to medical problems, which is what we have been doing in cancer and in COVID. A hapten is a chemical, a very simple chemical, and there are many of them, there are thousands of chemicals out there that would service haptens, but one that we have chosen to work with for a variety of reasons. When you hook a hapten up to a protein, you tremendously increase the ability of the body, whether it is a mouse or a human to respond to that protein. Not only that, in some cases, a protein which doesn't induce any kind of an immune response can be made to induce a response by haptenizing. The mechanism, this has been worked out, it has been worked on over many years and it's, it's understood down to the level of the cells.
We know that when you have to haptenize the protein and inject it properly, you get a strong immune response, not only to the haptenized protein, which of course is not what you are interested in, but to the original, unmodified protein, which is what you are interested in. You get two kinds of responses - one, you get an antibody response against the protein. Most of the people listening to this will know about antibodies because they are in the news all the time. But just as important or perhaps more importantly, you get a response from the other side of the immune system, which is called the T-cell mediated response. And although this is critically important, it doesn't make the news too much. It is a little bit more difficult to explain and much more difficult to measure which, which we will talk about more when we talk about our diagnostic. So you get an antibody response and a T-cell response. We believe that both are critically important in in helping people fight off or prevent severe infection or any infection at all with the virus that causes COVID-19.
SH: You just closed the second tranche of tranche of a non-brokered private placement to raise over two-million dollars Canadian in gross proceeds. Can you expand on this initiative for our investor audience?
James: The purpose of the recent successful fundraising was to replenish our working capital and really provide the balance sheet to enable the continued, successful, clinical, and commercial development of our various products. For example, we continue to move forward with the preparatory work for our phase one, ovarian cancer therapeutic vaccine trial, which will be done by our partner, ProCare Health Iberia, which is a large private pharma company based in Spain. It was a spin-out of Procter and Gamble. It is a large European biotechnology and pharma company focused on women's healthcare. We have partnered with ProCare Health on our ovarian cancer therapeutic vaccine, and our manufacturing partner, which is called Bio Elpida based in Lyon, France is beginning a preparatory work. We are working on that and we continue to also develop our COVID related products.
One of which is COVID DTH, which Dr. Berd alluded to, which very simply in that it is a skin test for T-cell immunity to COVID. Really the relevance is there's no way of that is economic or available commercially to do large-scale T-cell screening. It is very easy to do antibody screening. It is very easy to do PCR tests or other tests to see people are infected, but there is no practical or economic way to do T-cell screening. T-cell immunity is the most durable arm of the adaptive immune system, it is based on peer reviewed studies and data that has been published. In authoritative publications, it's very clear that that the T-cell immunity is really the key to getting over the pandemic. T-cell immunity tends to be more cross-reactive with different variants, at least based on case studies with other viruses and when T-cells are analyzed, it is clear that people that recover from COVID genuinely have strong T-cell immunity. What we want to do is to bring T-cell screening as an additional tool on top of antibody screening and PCR tests, and other types of screening.
SH: Can you tell us more about CoviDTH – your immuno-diagnostics tool? Sounds fascinating! This sounds like something that needs to be available right now. When will you expect to be filing your IND?
James: BioVaxys recently received a written response from the FDA to our questions regarding our planned IND submission later this year for CoviDTH. I'm very happy to report that the letter was quite positive and, effectively, our planned IND submission was effectively green-lit. We have already begun the work of preparing the IND and effectively our expectation is that we will submit the IND and hopefully, subject to FDA approval, we will be able to commence a combined phase one and phase two trial for, for CoviDTH. Again, CoviDTH is a diagnostic, it is effectively a skin test for T-cell immunity to COVID using a very well-known and widely used screening tool called delayed-type hypersensitivity.
We control the IP for using this for COVID with the spike protein that Dr. Berd mentioned earlier. I will mention that our scientific advisor Dr. Barrios from the Canary Islands (Spain) successfully completed two human trials with a very similar technology to CoviDTH and her findings were recently published in a prestigious periodical. With the very encouraging safety and efficacy data from her study really that is very encouraging for our plan, our planned Phase One/Two study.
SH: In the intro, I mentioned the SARS-CoV-2 and cancer vaccine platforms in development. Can you unpack the benefits of these vaccines?
James: In terms of COVID, there are COVID vaccines that have been, either fully approved or have emergency use authorization or similar authorizations around the world. One thing that's interesting about our vaccine is that we believe that, and the database center animal studies shows, that it produces a very robust T-cell response, which is very important in terms of helping to confer immunity against COVID. We are planning to do a study soon, to demonstrate our view that the haptenized spike protein has less ability to bind to the ACE2 receptor and theoretically, this could reduce the rare side effects and toxicities that are observed - albeit quite rare with the other vaccines that approach the spike protein. We will be announcing something on this shortly.
In terms of cancer, really our haptenized therapeutic cancer technology offers the potential for late stage cancer patients to really utilize their own immune system, to mount a T-cell response against cancer. I am very excited to continue the work that Dr. Berd started with his approach. David, from your perspective what, what do you see as the unique attributes of our cancer vaccine platform?
Dr. Berd: There are two important attributes. One is that we are immunizing people with their own cancer cells. In the old days, we call this autologous, but nowadays people call this personalized therapy, which is an easier concept to understand. There is a lot of reasons to think that even for the same type of cancer, that the cancer in one person is chemically, in a subtle manner, different from the cancer and in another person, so that if you want to immunize people, the best thing to do is to use their own tumor cells. Point one is we have a personalized or technically a what we call autologous vaccine. The second thing is we use the haptenization. It has been known for a very long time, too long, that just trying to immunize people with their own cancer cells is really hard and if it had been easy, the cancer problem would have been solved 30, 40 years ago.
Many people have tried it. The reason it is hard is, that cancer cells, to the immune system, look very similar to normal cells. When you inject the cells into somebody, the immune response generally doesn't recognize the cells as being foreign and doesn't make a response against it. As I alluded to a little bit earlier, when you put a hapten on the cells, you haptenize many proteins on the cell. Some of these are cancer antigens to which the body can respond, and you get a response to cancer antigens, which otherwise are invisible to the immune system, which leads to a much more robust response. We have data from some of the precursor technologies that we've worked with to indicate that this can result in meaningful anti-cancer effects.
SH: Why is their such a need for a new therapeutic option for ovarian cancer?
James: Ovarian cancer is a huge unmet medical need. Unfortunately recent innovations in cancer therapeutics and cancer immunotherapy like checkpoint antibodies, for various reasons do not provide really, unfortunately, enough of a benefit, especially for late stage ovarian cancer patients. We are quite proud that we have partnered with the World Ovarian Cancer Coalition, which is a non-profit, patient advocacy organization. Really, it is quite clear based on our communication with the community, that the world is screaming for new ovarian cancer therapeutics. David, and maybe just quickly in terms of ovarian cancer specifically, what is your view on really what we can offer and why this is our lead product?
Dr. Berd: Yes, the major breakthroughs in ovarian cancer, which were essentially developing effective chemotherapy were in the 1970s, and these were very important advances, but that was a long time ago. Most people present with advanced ovarian cancer, early detection has proven to be impossible so far. If you give chemotherapy, which was developed 50 years ago, you can cure about 25% of the patients, which is great, but at least for the other 75% who are not cured and who will eventually succumb to their cancer, there are many treatments, particularly traditional treatments like chemotherapy, which can help these people, but there are no curative treatments. Immunotherapy, for instance like our haptenized vaccine has, first of all, there is a great opportunity for it, the side effects we expect will be much less than chemotherapy. Based on previous work that was done we believe that it has the capacity to increase the survival of people with advanced ovarian cancer.
SH: Have you obtained any clinical data for your ovarian cancer vaccine?
James: Yes, David did work previously with the haptenized autologous ovarian cancer vaccine. In fact, there was a successfully completed phase two trial with excellent data. Now, BioVaxys has improved the formulation, so to speak and I'll leave David to get into the details. Effectively, we are starting again with phase one because of these improvements, but it is not radically different from what David was doing before.
Dr. Berd: The previous work was done with a hapten called DNP, which we modified the cells just with the DNP. These studies were done by me when I worked at Thomas Jefferson University and also by company that was a precursor to BioVaxys and in a small number of patients - I guess a total of about 50 patients were treated. We established that the treatment was very safe with very little side effects and that the clinical effects looked very promising, and the survivals appeared to be much longer than one would expect with traditional treatments. Of course, these were not phase three comparative trials, but in single arm trials. When BioVaxys was started, we decided that we needed to make sure the vaccine was up to date.
I had already done some work on what we call, a bi-haptenized vaccine, which is modified with two haptens. It sounds trivial but is not because the two haptens we use are immunochemically distinct and they modify or stick onto different parts of proteins. Therefore, you get a much greater modification of tumor antigens and theoretically a much more potent immunological response. We decided that since we were starting a new company, we would start with a new and improved technology. We expect that the results of the bi-haptenized vaccine will be at least as good as what we saw previously with the old one. We have a lot of reason to think that actually the results will be better. We have not yet done any clinical trials, but we expect to start a phase one/two trial as James alluded to in Europe next year.
SH: The Company looks set for strong growth in 2021. How are you placed to expand operations?
James: As I mentioned earlier, our partner in France is ramping up the work to begin the production of the ovarian cancer vaccine. What is very exciting is that our partner Bio Elpida has a dedicated manufacturing facility in France. Our view is that that this really would allow us to expand. As we move, for example, into other cancers it will be great having this dedicated facility. That is a really important breakthrough for us. In addition, we have just established an office in Ontario, Canada where we're taking advantage of the deep life science industry there to begin work on some of our COVID related products. Stay tuned, but I think we will see significant development of our infrastructure and supporting our various projects in the coming six months.
Dr. Berd: The haptenized cancer vaccine technology is a platform technology, and it is theoretically applicable to many other cancers. With the old technology, we not only worked on ovarian cancer, we worked on melanoma and there were hundreds of patients treated with, again in single arm trials, not in controlled trials, but with excellent results that were published in first rate journals. There already is data in melanoma and ovarian, and we are starting with ovarian because there's such a great need for a treatment, that we think that success in ovarian would lead to clinical trials in multiple other cancers.
SH: For company shareholders and potential investors, what kind of future clinical-stage development and progress can we expect for your vaccines moving forward?
James: As we mentioned earlier, we are going to launch the phase one ovarian cancer trial next year. We are expecting to launch the phase one/two trial for CoviDTH once we have the approval of the IND. In addition, I should mention that as part of the collaboration partnership between BioVaxys and ProCare Health Iberia, BioVaxys has the right of first refusal to market a product called Papliocare, which is the first device for treating HPV dependent, cervical lesions, which is a huge problem around the world for women. Papliocare is approved in the European union. It is already on the market as an over-the-counter product you can look it up and it is a significant revenue generator in Europe. It is for the FDA to review, and depending on how it goes with the FDA, if Papliocare is approved in the United States, we intend to exercise our right of first refusal to market Papliocare, and that is going to be great because that means we could be generating revenue next year from an approved product.
SH: What separates BioVaxys from the competition and makes your business model unique?
James: I'll hand it over to Dr. Berd to discuss on the technology side, but in terms of the investment side - in terms of the previous work that was done, not by our company, but by other companies in the university that the Dr. Bird was associated with, the cumulative investment in our cancer vaccine technology is probably in excess of US$130 million. There has been significant investment. There have been over 500 human volunteers that have been vaccinated with the haptenized cancer vaccine that Dr. Berd developed in FDA approved trials. In terms of the technology, there is a lot of skin in the game. In my view, that really sets us apart from other companies. Then in terms of business development, between CoviDTH as well as Papliocare, I think we are a lot closer to revenue than the market is understanding. And then on, on the technology side, we are the world leader in haptenized vaccine research. Just to wrap it up, David, if you could discuss what is unique about our company from your perspective?
What has become interesting to me is that we are taking one immunological phenomenon, which is the kind of esoteric to people and probably to most investors, which is this concept of haptenization, and we're applying it to two very different diseases - one cancer, two viral diseases. By the way, we think that the work that we're, that we are doing with COVID-19 is, there is absolutely no reason why it is not applicable to other viruses. For example, there is a big need for improvement in the vaccines for influenza which have been on the market for many years, which are not as effective as we would like them to be. That is an area that we could go into. It is interesting to me, and I think unique, or at least unusual that we are taking one scientific phenomenon and applying it to two very different kinds of human diseases.
SH: I have to mention your stock has been on a bit of a roller coaster ride over the past 12 months. What can you tell our investor audience regarding the current valuation of your stock and why you think it’s a good buy right now?
James: I will preface that my response, with the observation that biotech is extraordinarily volatile. It is a very high risk, high reward industry, and that is true for every small cap biotechnology stock. We, and if you speak to any CEO, they're going to tell you their company is undervalued. When you look at our peer group and by which, I mean on the cancer side, companies that are pre-revenue, that clinical stage developing novel cancer related technologies, they have market caps or enterprise values that are multiples of the invested capital, the cumulative research and development costs that went into developing the technology and we are trading at a fraction of that cost. That is a very interesting metric.
You can look at a very successful large company listed on NASDAQ, Adaptive Biotechnologies - Adaptive have developed a T-cell test for COVID and had probably a billion dollar lift to its market capitalization, related to developing that product. That T-cell test requires a blood draw, and it is still extraordinarily expensive in my view where it is just not going to be commercial. Just that one product, CoviDTH, really could mean a massive multiplier for our market capitalization. I think when the COVID vaccines that, that did get emergency use authorizations came out, maybe there was some negative sentiment towards their COVID vaccine, but, I just need to remind shareholders that we are a very broad company that, and I would say that our main focus is on cancer.
We do have an outstanding COVID vaccine candidate. We do have a very exciting CoviDTH - our skin tests for T-cell immunity to COVID. I think we are well positioned to benefit from the continued pandemic, but our story is much larger than that. As we get closer to exercising our marketing rights for Papliocare, that that alone could support a significantly higher valuation than where we are trading. If you look at the SETI records, when I've been allowed by my lawyers, I've been buying the stock in the market, I've been participating personally in the private placements. I am a huge believer and I intend to add to my shareholding when the opportunity is lawful.
SH: What’s the long-term strategy for the company moving into 2021 and beyond, and what should retail and institutional investors be looking out for?
James: It is very interesting if you look at the number of transactions in the oncology space globally, this really has been one of the hottest areas in life sciences. I think as BioVaxys gets further down the road in clinical development, I would not be surprised to see that there would be strategic, big pharma or financial interests in our company. We want to position BioVaxys to be become, frankly, an acquisition target, but I think it is to early for that. Oncology space, there is a lot of money available, there is huge need and demand for novel therapeutics and therapeutic vaccines. I think we're very well positioned to benefit from that consolidation.
SH: Can you tell our audience a little bit about your corporate management and board teams, along with the experience and innovative ideas they bring to the biopharma space?
James: I mentioned on our board we are very lucky to have David Wang, who is a seasoned biotechnology, pharmaceutical and medical device entrepreneur, and senior executive. He has had very high-level positions, in particular, in large Chinese and Japanese biotechnology and biomedical companies. He has a lot of business experience and contacts, and it is great to have him on the board. In terms of our scientific and advisory panel, at least from my perspective, it’s quite impressive. On the policy side, we have a policy advisor, Professor Adam Coots, who is an expert in really in global health crises and very plugged into various multilateral, public health authorities that are potentially providing a lot of very useful feedback, and scientific information in terms of our COVID related products. David if you could just discuss some of our scientific advisors on the cancer side and the virus side.
Dr. Berd: On the cancer side, we have been lucky enough to acquire the services of Dr. Charles Dunton, who is a gynecologic oncologist, was formerly Professor of Medicine at Jefferson, who was quite well known for doing clinical trials in ovarian cancer. He actually was one of the first people I worked with, when we worked on ovarian cancer vaccines a number of years ago. He is not only knowledgeable, but he is very well connected, which is very, very helpful for a company like ours. James already mentioned Dr. Barrios, who was someone, who was basically a stroke of luck that we found each other, but you really could not do any better than somebody who is already working with the technology that you want to develop. That is of tremendous value to us. We have two basic virology consultants, who are basic scientists working in the virology area who we can turn to, which is very important when there are new developments in virology that maybe are a little bit beyond my expertise who can explain them to us and put them in perspective. We have got an excellent team of people who compliment the three full-time people in the company and will be very important as we move forward.
James: I would be remiss to mention, to fail to mention, we have a business development advisor, Shmuel Farhi, who is a legendary billionaire real estate developer based in Ontario. More importantly than that, he is a very significant investor in the Canadian, American, and Israeli biotechnology industries. One of our largest shareholders. He has a team of very impressive scientific advisors predominantly based in Israel. I say we get excellent business development advice from Mr. Farhi.
SH: And finally, gentlemen, if there’s anything I’ve overlooked please feel free to elaborate.
James: I think you have touched on all the material and important points with BioVaxys. so we are, we're grateful for your attention and really enjoyed discussing the company with you.
Dr. Berd: The only thing that I would add, is because we have been working on the technology for a long time, there is a vast amount of published peer reviewed literature, that is available, that forms the scientific background of what we are doing. Many investors are interested in this kind of thing, and we certainly are more than happy to supply it. We think that it is impressive and very supportive of what we are going to do in the future.
