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Tunitas Therapeutics (Private) |
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September 17, 2012 Issue |
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The Most Powerful Name In Corporate News and Information |
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CURRENT ISSUE | COVER ARCHIVES | INDEX | CONTACT | FINANCIALS | SERVICES | HOME PAGE |
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As an Inhibitor of Basophil and Mast Cell Function and having the Ability to Turn Off their Signaling through the IgE Receptor, Tunitas Therapeutics’ GE2 is a Game-Changing Therapeutic for Patients with Moderate to Severe Asthma and Life-Threatening Food Allergy |
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www.tunitastherapeutics.com |
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Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – September 17, 2012
Dr. Sigal: There are two things really. One is that when I reconnected after many years with Andy Saxon, my co-founder and professor at UCLA, I quickly recognized that what Andy had was an absolutely game-changing technology. This is something that certainly was as transformative as the technologies at Pharmacopeia in combinatorial chemistry and at Cytokinetics, with their cytoskeletal cell biology technology. In my career, I have always looked for things that I viewed as really solid science and potentially game-changing with respect to therapeutics and Tunitas had both of those things.
Dr. Sigal: Tunitas is an allergy therapeutics company. As I have already mentioned, this is technology from the Saxon laboratory UCLA. What Andy had come up with was a family of small fusion proteins consisting of parts of antibody molecules put together in a unique way that block the activation of the key allergic cells in the body. It does this in a very novel and specific fashion. That is the underlying technology that powers the entire Tunitas platform.
Dr. Sigal: Every cell in the body has many receptors on their cell surface. The key to triggering an allergic response is that the key allergic cells have receptors for a particular type of antibody, the IgE antibody. That is the type of antibody that drives an allergic response. These IgE antibodies bind to a receptor on the surface of these cells and look for any allergen to come into the system, whether it is in the respiratory tract, the skin or gastrointestinal tract. If the allergen comes in, it interacts with the IgE and these cells become activated within minutes, which is why an allergic response happens so quickly; these cells produces a whole variety of things like histamines, leukotrienes and a variety of cytokines. Our protein binds to that IgE receptor and also binds to a second receptor, which transmits a negative signal to the cell and completely turns off the activation process.
Dr. Sigal: There are variations. We have two major programs ongoing at Tunitas. One is a protein, which we call GE2, that blocks all allergic responses and will be administered as a monthly subcutaneous injection. It is our most advanced of our therapeutics, ready for full-scale preclinical development, clinical manufacturing, and toxicology. We could have clinical proof-of-principle data in about two and a half years from where we are right now. We are developing this protein for moderate to severe asthma, which is a major unmet medical need. There is a second part of the platform which is specific for particular allergens and we have two programs there: one for cat allergy and one for peanut allergy. Those proteins would be given in the same fashion as you receive an allergy shot in the doctors’ office today; except that, rather than going to the allergist for three to five years, which of course you cannot do for food allergies at all, we believe, based on our animal model data, that in three to six months you would be essentially cured of your particular allergy.
Dr. Sigal: We will have to do a very careful, well-controlled clinical trial where we would not put individuals at risk with any major adverse reactions. We would not advocate once someone took our peanut allergy vaccine that they go out and eat a bag of peanuts. What we would be able to do is say that if you encounter peanuts at a Chinese restaurant or in the cafeteria at the lunchroom at school, you will not be at risk for any sever reactions. It would move the bar so that people would feel much more comfortable than they are now in being exposed to peanuts.
Dr. Sigal: In the asthma field, there are at least a half a dozen other biologicals that are being developed, many by large pharmaceutical companies. Many of those have failed in clinical trials, so it is actually viewed as a risky area. Clearly, there is competition with respect to other injectable proteins that would be given once a month for asthma. We think we have an advantage because of our mechanisms, but clearly, there is competition. In the food allergy space, there are clinical trials where people are trying to desensitize people to foods -- milk, eggs and things like that -- but in terms of what we are trying to do which really moves more towards long-term tolerance, we are in a very unique position.
Dr. Sigal: I think they have a cautious interest in this area. Clearly, it is quite different and quite frankly, until we see results in our clinical trials, I think people are justified in remaining skeptical.
Dr. Sigal: We actually have developed a fairly unique model which I think speaks to the current ennui in the entire investment community. We have not taken in any outside investment dollars or venture capital dollars; we are entirely funded by grants and have generated over $7 million in grant funding to date. We have a very efficient model with respect to operations and essentially our entire pipeline of drugs has been generated on grant money. For an investor, in other words, basically the entire pipeline comes for free. We are looking for a small investment now to take our lead program GE2 through the first part of the clinical process to the point where we would have an opportunity to partner with a large pharmaceutical company for those larger asthma indications.
Dr. Sigal: It is little bit of both. Andy and I both have long academic track records, we are both pretty good at writing grants, but behind that is the fact that what we are pursuing is extraordinarily solid science. The platform is based on very good basic research that was done at the university level; this work has generated a lot of interest and momentum not just because we write good grants but because the science is extraordinarily strong and we are asking some fundamentally interesting questions in the area of immunology and allergy.
Dr. Sigal: Those are a bunch of potentially interesting programs, but one of the things that I have always focused on as a biotech entrepreneur and leader in research is to stay focused. We have three programs and we are going to see those through to clinical proof-of-principle. The good news is that if these programs work, particularly in the area of food allergies, there are twenty or thirty other allergens that we can address with exactly the same technology; but we are going to prove it first with cat and peanut.
Dr. Sigal:
I think this is a model that is not only scientifically very sound and well
validated with respect to the clinical opportunities but one that is also
very capital efficient. An investor coming in now really has the opportunity
to get Tunitas over the hump. At the same time that we are completely
prepared to continue to take our programs forward with grants, time is
always a factor. Therefore, having a small amount of investor money now will
accelerate the entire development process and that would not only benefit
the technology but the investors as well. |
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In my career, I have always looked for things that I viewed as really solid science and potentially game-changing with respect to therapeutics and Tunitas had both of those things. - Nolan H. Sigal, MD, Ph.D. |
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