Interview with: Denis D. Corin, President and CEO - featuring: their innovative therapeutics and vaccines in the areas of oncology and infectious disease; the company’s lead product, the TAP vaccine performs a key step in moving characteristic markers called antigens to the surfaces of cells.

TapImmune Inc. (TPIM-OTC: BB)

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TapImmune Is Putting TAP Back Into Cancer Cells, Which Creates The Markers That Tells The Immune System That There Is An Infected Cell – Go Kill It



Healthcare
Biotechnology
(TPIM-OTC: BB)


TapImmune Inc.

202-3590 West 41st Ave
Vancouver BC Canada
Phone: 604-264-8274



Denis D. Corin
President and CEO

Interview conducted by:
Lynn Fosse, Senior Editor
CEOCFOinterviews.com
Published - February 8, 2008

BIO:
Denis D Corin

President, Chief Executive Officer
Denis Corin is a management consultant with experience in large pharmaceutical (Novartis), diagnostic instrumentation companies (Beckman Coulter) as well as the small cap biotech arena (MIV Therapeutics). He holds a double major, Bachelors degree in Economics and Marketing from the University of Natal, South Africa.


Company Profile:
TapImmune Inc. is a biotechnology company specializing in the development of innovative therapeutics and vaccines in the areas of oncology and infectious disease. The company’s lead product, the TAP vaccine performs a key step in moving characteristic markers called antigens to the surfaces of cells. Without TAP, there are no cancer markers, so the immune system fails to spot the rogue cells and the cancerous cells can grow undetected. The Company’s vaccine has shown effective restoration of TAP which restores and augments the marker (antigen) presentation and subsequent recognition and killing of cancer cells by the immune system. The TAP molecule also works as an adjuvant or ‘accelerant’ to enhance targeted vaccines against infectious diseases. Including TAP in the studied Smallpox Vaccine showed potency was increased by 100-1000 times. The company is currently developing AdhTAP for the commencement of toxicology studies leading to the initiation of Phase I clinical trials. The global vaccine market is expected to grow from $13 billion in 2007 to $21 billion in 2010.

The company’s technologies have been featured on ABC News BusinessNow, B-TV, in BusinessWeek, Popular Mechanics and local news papers as well as many respected medical journals including the Journal of Immunology, Nature (Biotechnology), International Journal of Cancer, Cancer Research and PLoS Pathogens among others.

CEOCFO:
Mr. Corin, what is your vision for TapImmune?
Mr. Corin: “Basically TapImmune specializes in the development of innovative therapeutics for cancer and infectious diseases. Our long-term vision is to be able to bring to market a product or partner with a company using our technology to bring a product to the market that would provide some significant benefit for patients suffering from cancer all over the world, as well as an innovative product for prophylactic vaccine for infectious diseases. Those two products are basically formulated from the same technology which stems from our core technology which is transporters associated with antigen processing (TAP) and our ability to increase the presentation of those antigens on the surface of an infected cell, whether it is a cancer cell or infectious disease.”

CEOCFO: What is the technology all about, is it a novel or common concept?
Mr. Corin: “Our core technology stems from transporters associated with antigen processing. In a normal functioning body and cell, these transporters are responsible for putting markers onto the surface of cells so that your immune system can recognize if the cell in infected or has a cancer. Your immune system would then through its regular course of business and immuno-surveillance recognize that there is a problem with that cell and it would be tagged for destruction by your immune system. When cancer starts to grow in the human body it tries to evade detection by the immune system, which is why tumors grow undetected until they are found through an examination by physician or yourself. The reason for that is those transporters have been down-regulated by the cancer and the markers are not effectively pushed to the surface of the cell so the immune system doesn’t recognize them. Our scientist Dr. Wilf Jefferies discovered this when he was investigating why cancers are so effective at evading the immune system. He looked at the various chaperones that were responsible for pushing those markers to the surface of the cells and discovered that TAP (Transporters Associated with Antigen Processing) was a major component there and that in cancers those components have down-regulated or eliminated by the cancer as it grows. He hypothesized that if he could re-introduce TAP into cancer cells, it would reestablish that pathway or the ability for those cells to put that warning signal, or that flag up on the surface of those cells so that the immune system could recognize that there is cancer there and go kill it. After years of research and scientific discovery and trials, the research is overwhelming that by putting TAP back into a cancer cell, it does reestablish that pathway and the cancer will be recognized by the immune system and be killed by the immune system. We have seen some very significant results in our animal studies that show cancer being completely eradicated and the long-term survival of animals infected with cancer is significantly increased. In terms of long-term strategy and vision, if transporting this into the human body, if it is half as effective as it has been in small animals it will be an amazing coup for the treatment of cancer through a therapeutic vaccine. That is one side of the technology in terms of cancer. We are up-regulating the cancer cell’s ability to be recognized by the immune system.

Secondly, Dr. Jeffries hypothesized that if it works very well in an area where TAP has been eradicated or is just not present, what happens if we put a little bit more TAP into a cell that is normally expressing TAP in conjunction with a prophylactic vaccine. These would be vaccines such as your common influenza vaccine, small pox vaccine, or any infectious disease vaccine that we have as a preventative treatment. What if we add TAP to that environment, would it make those vaccines more effective by adding more of these little flags for the immune system to recognize? Again, through trial and research we found that it is extremely successful and the results have been very well publicized in the media. He was able to show that by adding TAP to the current small pox vaccine, he could make that small pox vaccine a hundred to a thousand times more effective, so you could reduce the dose by about that amount and still have the same efficacy. That is really important because today we are always faced with the problems of pandemic outbreaks such as bird-flu, or a number of these other viruses even influenza. If we could include our TAP product as an adjuvant to those vaccines we would be able to have coverage for all populations because we make the vaccine so much more potent, so, the little that we can manufacture would go a lot further. In addition, we would be reducing the dose substantially so people who are immuno-compromised or challenged who couldn’t take a for example, small pox vaccine, are reducing the dose significantly by adding our product. That means that we should be able to immunize those types of patients who are immuno-compromised or diabetic or just have some other adverse effect to the dosage.

So to summarize; there are two core technologies, one is in oncology and cancer and helping your body fight cancer, and make cancer visible to your immune system and the other is prophylactic vaccine for infectious diseases. We also have two huge markets, two very substantial benefits to patient populations and very interesting technologies and it has been well-publicized in the media.”

CEOCFO: Where are you in the process of getting them through?
Mr. Corin: “We are just starting the development phase of both of those product lines and the research and data has now been gathered and we are in the position where we can start to manufacture those vaccines and both iterations of the product under GLP or GMP guidelines, which are required by the FDA. Therefore, we are at the beginning of the product development lifecycle. The research has been completed and now we have to move the development of that into FDA regulated and approved facilities to basically grow up the vaccines. We have to get them to a point where they are fit for human consumption and then we have to do two final toxicity studies before we can initiate Phase I human studies in both of those areas. Just by the nature of biotechnology and the fact that there is not a manufacturing process as most of us are used to where we can work with partners, add more people and more equipment to make them faster. In biotechnology, you are relying on growing viruses and cells replicating, so it is a biological process that can’t be sped up. It will probably take us fifteen months to get through the biological growth or biological manufacturing process to develop and build these vaccines and grow them on the various cell lines that they need to be grown up on for our final 2 toxicity studies prior to Phase I and an investigational new drug (IND) filings with the FDA.”

CEOCFO: You recently had a new patent granted; would please tell us about that and the significance?
Mr. Corin: “We actually have a number of patents and the one that you are referring to is actually a continuation of our core patent that was revived and the petition to revive that and send it off for continued examination was granted. That particular one is important because it expands our technology focus into the infectious disease arena and allows us to use different types of vaccine carriers or viral carriers for our therapy. That was just a continuation of one of our parent patents. We have a number of patents in cancer and infectious diseases on those two technologies that are pending and applied for. We have one issued patent in a number of countries around the world. We have additional technologies that we are bringing in that will compliment our core technologies that are also under our assignment, from the university where we grew the technology out of.”

CEOCFO: How are you funded for development?
Mr. Corin: “That is a challenge. Sometimes I wonder when I am trying to raise the money to continue our development, just how many of these novel and exciting technologies do not come to the market because of lack of funding. You have to go out there into the public market to raise the money and it is not always an easy thing to do. That is one of the more challenging aspects of running a public company with technology that we all think could be life changing or world changing. We just have to be able to communicate that to investors. We hope to continue to do that; we have raised close to 12 to $15 million over the last five or six years for the development of this technology and we continue to do that in the public market through investors or funds and that will continue to be a part of our business plan.”

CEOCFO: Are partnerships in the future or is it too early for that?
Mr. Corin: “Absolutely they are in the future and that is just the nature of what our adjuvant product is. By adding our TAP to an already available prophylactic vaccine like an influenza or small pox vaccine, you make those vaccines so much more potent and also use significantly less innoculae or dose. Partnerships with those companies that manufacture those type of products are a very real possibility and is something that is a part of our business plan. We envision bringing our first revenues in or our first product to market could be through partnering with an established vaccine company. We are a fairly small company so the ability to partner with one of those major pharmaceuticals or vaccine manufacturers is attractive to us and I think our product brings a benefit to them as well, so I think those types of partnerships are very real.”

CEOCFO: Why should potential investors pick TapImmune out of the crowd and what should people realize that they might not see when they first look at the company?
Mr. Corin: “Biotech companies can get kind of complicated, and sometimes trying to understand the technology is a challenge. I believe that this technology has significant promise to bring a therapeutic vaccine for cancers that in my mind and what we have shown in preliminary preclinical trials could bring a potential substantial therapeutic treatment to people suffering from cancer. The reason why I am here is because I really believe in this technology and I believe that it will have a significant impact on the fight against cancer and other infectious diseases.

For investors, you have to look more closely at the technology and what differentiates us from a lot of the other companies that are out there in our space. Many technologies can elicit a bigger immune response so you can basically antagonize the immune system to create more soldiers to go out and fight against particular types of cancers. The trouble with those is it doesn’t matter how many soldiers you have if there is not a target for those soldiers to go and attack, they are not going to be very effective and that is exactly where our technology differs from most of them. Our technology works from the inside out, it actually goes to the cancer cells themselves and ‘lights up’ the cancer cells for lack of a better terminology. It makes those cancer cells visible to all those soldiers out there trying to fight in your immune system, and that differentiates us significantly from a number of the other cancer vaccine companies who are effectively generating more soldiers to fight the battle. Our technology lights up the target for those soldiers to go and target and kill. Our immune systems are very capable, our immune systems can kill cancer if they can only see it and that is what our technology does, it allows our immune systems to recognize the cancer. The benefit of that is significant.”

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“Many technologies can elicit a bigger immune response so you can basically antagonize the immune system to create more soldiers to go out and fight against particular types of cancers. The trouble with those is it doesn’t matter how many soldiers you have if there is not a target for those soldiers to go and attack, they are not going to be very effective and that is exactly where our technology differs from most of them. Our technology works from the inside out, it actually goes to the cancer cells themselves and ‘lights up’ the cancer cells for lack of a better terminology. It makes those cancer cells visible to all those soldiers out there trying to fight in your immune system, and that differentiates us significantly from a number of the other cancer vaccine companies who are effectively generating more soldiers to fight the battle. Our technology lights up the target for those soldiers to go and target and kill. Our immune systems are very capable, our immune systems can kill cancer if they can only see it and that is what our technology does, it allows our immune systems to recognize the cancer. The benefit of that is significant.” - Denis D. Corin

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