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TomegaVax Inc. |
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June 15, 2015 Issue |
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The Most Powerful Name In Corporate News and Information |
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Lifelong T-Cell Response Generation for Pathogens |
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CEO
TomegaVax Inc.
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – June 15, 2015
CEOCFO: Mr. Tippie, would you tell us the idea behind TomegaVax? Mr. Tippie: The idea behind the company is to generate lifelong T-cell response to a variety of pathogens.
CEOCFO: Would you tell us why that is important? Mr. Tippie: We have published data, which indicates that we can eradicate SIV, which is the closest animal analogue to HIV in humans. In about half of the monkeys that have been treated, we see no disease whatsoever and cannot re-infect the monkeys even if we try. We have about sixty-five monkeys that have been cured of SIV at the present time at the Oregon National Primate Research Center (ONPRC), where we are co-located in the Portland, Oregon area.
CEOCFO: What do you understand that is allowing you to get the results you are seeing so far? Mr. Tippie: This comes out of about fifteen years of work led by Louis Picker, M.D. at the Vaccine and Gene Therapy Institute at Oregon Health Sciences University. Dr. Picker’s original observation, was that Cytomegalovirus (CMV) (which is a common and largely benign virus) elicits a profound T-cell response—for example, at any one given time for those of us who are CMV infected, up to 20% of our circulating T-cells are focused on CMV, which is an extraordinarily high number. He hypothesized that he might be able to exploit that ability of CMV to generate a profound T-cell response and train it to generate a similar T-cell response to other pathogens. That vision by-and-large has been successful. We have the SIV data that I mentioned. Using the CMV system, we have generated profound data in TB, which has not yet been published. We also have data on malaria, as well as some preliminary data on prostate cancer.
CEOCFO: What is the timeline for you? Mr. Tippie: I want to distinguish between the effort that is going on at the university, primarily in Dr. Picker’s laboratory, and what is going on at the Company. At the University, Dr. Picker received a $25 million grant last July to take an HIV prophylactic vaccine into the clinic and then into Phase 1. That is very significant for the company because that will be our first human data with the platform, so it will generate safety and immunity data in humans. That data will be available in mid 2017. The academic work de-risks the work we are doing in the company because we will get this early clinical data on the platform, which is applicable to all of our vaccines through the Gates Foundation funded work at the University. At the company, we are focusing on therapeutic vaccine and there is a significant market opportunity in the developed world for these drugs. At TomegaVax, we are focused on developing therapeutic vaccine to HPV (causes cervical and oral cancers), HSV-2 (genital herpes) and Hepatitis B.
CEOCFO: What have you learned so far in your early testing that is better than originally thought? Mr. Tippie: First, the generation in monkeys, of what appears to be a lifelong population of effector memory T-cells to inserted pathogens--that is unprecedented. Others have shown transient effects. We have monkeys that have now been inoculated with the vaccine with the basic CMV platform for almost ten years now and they still show very high levels of effector memory T-cell response and that is absolutely unprecedented.
CEOCFO: Is the medical community aware? Mr. Tippie: Physicians are not aware of this yet. We are in discussions with most of the major drug companies in the world that have interest in immunotherapy--vaccines and therapeutic vaccines. The vision is that if you have the disease you will be given two shots and you will be protected for life and the disease will be cured. We have cured monkeys so far and not people. I am raising a significant financing right now in the company to advance our therapeutic vaccines into the clinic. This is in addition to the academic work that is going on at the University.
CEOCFO: Different aspects of the medicine go in and out of favor with the investment community. What are you finding as you are raising funds? Mr. Tippie: Immunotherapy in general is quite hot right now. Most of that interest is in cancer and less in infectious disease. This platform should be applicable to cancer as well, but we are very early on in cancer. I would say that there is strong interest from the investment community. I think the Ebola crisis heightened that interest and brought the problem to the forefront of peoples’ thinking. Antibiotic resistance has also raised awareness; if you can vaccinate against some of these pathogens, you would not need to worry quite so much about having antibiotics for them.
CEOCFO: Have you seen any side effects so far? Mr. Tippie: Not so far. It has been very well tolerated by the monkeys. We have around 450 monkeys under treatment right now and this (ONPRC) is the largest primate center in the country.
CEOCFO: Are you holding off until you get the human data? Mr. Tippie: No we are not holding off. It is full-steam ahead. We still have two years of pre-clinical work to do before we get into the clinic in the company. There is quite a bit of monkey data that needs to be assembled. There is some interesting curiosities coming out of this work in terms of new immunology that needs to be explored, we feel.
CEOCFO: This is not your first go in the life science industry. What have you learned from previous ventures that have been helpful? Mr. Tippie: From the scientific side, I would say there are certain areas of science and medicine that are more or less tractable. In terms of being able to bring something through clinical trials in a reasonable amount of time—Stroke is an obvious example of something that has been a black hole for money. I swore I would never do another immunology deal after I did StressGen Biotechnologies Corp. in the 1990’s, because immunology is such a black art. That said, immunology has changed a great deal. They are few disciplines in science that have seen so much change in the intervening years. I think immunology is a very hot area right now and I think most of the pharmaceutical companies we talk to would agree. It is very hard to raise the money and to go after an incremental solution in a little company when little companies have this economy to scale, is foolish in my opinion so it has to be a huge problem for me to get excited.
CEOCFO: Is there much competing research? Mr. Tippie: Is there competition in the platform and are other people able to generate T-cell responses? The answer to that is yes. But so far, no one else has been able to generate long-term T-cell responses. There are others that certainly have platforms, using other viruses, antigen combinations; there is a list of companies doing this. But nobody has generated the long-term effector memory T-cell response that we have, to our knowledge. With respect to the specific diseases that we are going after, sure there is competition. Yes, there is competition in all of these spaces. We believe that we have well differentiated products in each of our therapeutic areas.
CEOCFO: Why is TomegaVax noteworthy today? Mr. Tippie: We believe we have a platform that is applicable to many infectious diseases and cancers that will generate cure. We have extremely promising animal data in three diseases now in monkeys that are very good models for translation to man. We are the only group to our knowledge that has generated long-term effector memory T-cell responses that are thought to be so essential to fighting both infectious disease and cancer. |
"We are the only group to our knowledge that has generated long-term
effector memory T-cell responses that are thought to be so essential to
fighting both infectious disease and cancer."
TomegaVax Inc.
Michael Tippie 425-830-5805
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Immunotherapy Companies, TomegaVax Inc., Drug Development Companies, CEO Interviews 2015, Michael Tippie, MS, MBA, Lifelong T-Cell Response Generation for Pathogens, vaccines and immunotherapies for chronic and recurring viral infections including, SIV, Human Immunodeficiency Virus (HIV), Human Papillomavirus (HPV), Hepatitis B Virus (HBV) and Herpes Simplex Virus (HSV), Recent CEO Interviews, vaccine technology platform to areas of unmet medical need, vaccine technology that provides continuous low level antigen presentation to maintain an active T-cell-mediated immune shield, lentivirus infection (simian immunodeficiency virus or SIV). CMV-based vaccines have demonstrated pre-clinical efficacy in animal models of Tuberculosis (TB), Malaria, Ebola Virus, and cancers including prostate cancer and melanoma, therapeutic vaccination of chronic viral TB and Malaria, TomegaVax Inc. Press Releases, News, Drug Development Stock, Companies looking for venture capital, Angel Investors, private companies looking for investors, drug development companies seeking investors, immunotherapy companies needing investment capital |
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Michael
Tippie, MS, MBA