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With Restructuring Completed in January 2011, the New Coronado Biosciences, Inc. is an Immunotherapy Company with One Product Focused on Autoimmune Diseases and the Other Product Focused on Immunotherapy for Cancer
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Coronado Biosciences, Inc.
is engaged in the development of novel immunotherapy biologic agents. The
Company's two principal pharmaceutical product candidates in clinical
development are: CNDO-201, a biologic for the treatment of autoimmune
diseases, such as Crohn's disease, ulcerative colitis and multiple
sclerosis; and CNDO-109, a biologic that activates natural killer (NK)
cells, for the treatment of acute myeloid leukemia (AML) and solid tumors.
For more information, please visit www.coronadobiosciences.com.
President & CEO and Director
Dr. Sandage has served as
our president and chief executive officer since April 2011 and has over 30
years of experience in the pharmaceutical industry, most recently as the
vice president and head of oncology research and development for Covidien
Pharmaceuticals, a specialty pharmaceuticals company, a position he held
from March 2010 until March 2011. From November 1991 to December 2009, Dr.
Sandage held various positions at Indevus Pharmaceuticals, a specialty
pharmaceuticals company, including executive vice president of research and
development and chief scientific officer, prior to the sale of the company
to Endo Pharmaceuticals. Prior to joining Indevus Pharmaceuticals, from 1981
to 1991, Dr. Sandage held senior drug development positions at DuPont Merck
Pharmaceutical Company, DuPont Critical Care (formerly American Critical
Care) and Merrell Dow Pharmaceuticals. Dr. Sandage is currently a member of
the board of directors of Gentium S.p.A., a pharmaceutical company. Dr.
Sandage has also served as a member of the board of directors of Osteologix,
Inc. and Genta Incorporated. Dr. Sandage has a B.S. in pharmacy from the
University of Arkansas and a Ph.D. in clinical pharmacy from Purdue
CEOCFO: Did these products come from the same technology?
Dr. Sandage: No. TSO was a discovery from the University of Iowa by Drs. Joel Weinstock, Elliott and Summers. It was originally licensed to a company in Germany called OvaMed. Coronado then licensed the rights for the use of TSO for all indications for North America, South America and Japan from OvaMed. The NK program comes out of the University College of London, where professor Dr. Mark Lowdell, the inventor is located. It was licensed directly from the University.
CEOCFO: Does Coronado Biosciences own both of these 100% right now?
Dr. Sandage: As I mentioned we have licensed worldwide rights for all indications from the University College of London, for which we owe a single digit royalty on net sales. Again as I mentioned, TSO is licensed from OvaMed, who has the original license from the University of Iowa. We have the rights for all indications in just for North America, South America, and Japan. We pay OvaMed a royalty of 4% of net sales and they in turn pay the University of Iowa 4%. We purchase TSO from OvaMed, our exclusive manufacturer. In addition, OvaMed has a partner in Europe. Their partner in Europe, the Dr. Falk Pharma company licensed just the gastrointestinal indications. I am not sure of the details of their business arrangement. However, I would like to point out that we just signed a three-way agreement with OvaMed and the Dr. Falk Pharma company. Coronado, Dr. Falk Pharma and OvaMed have agreed to enter into a Collaboration Agreement under which Falk will grant Coronado exclusive rights and licenses under certain Falk patent rights, pre-clinical data and clinical data from Falk’s clinical trials of TSO in Crohn’s disease, including an ongoing Phase II clinical trial, for use in North America, South America and Japan. Coronado will grant Falk exclusive rights and licenses to Company data from planned clinical trials of TSO in Crohn’s disease for use in European studies. The hope is that it will accelerate both of our programs and reduce the overall cost for the programs going forward.
CEOCFO: Could you give us a brief description of the technology, what it is and why you are finding it effective, first for the CNDO-201 with the TSO for autoimmune diseases and then for CNDO-109 which is for the NK (natural killer cells) that activates them?
Let’s start with CNDO-201, we call it TSO. It stands for Trichuris suis
ova or more commonly known as pig whipworm eggs. It is an intestinal
helminth or intestinal parasite. The idea of using a helminth as a
therapeutic agent is based on what is known as the “hygiene hypothesis”.
This concept was developed by the group at the University of Iowa. As I
mentioned earlier, Dr. Weinstock and his colleagues are all
gastroenterologists and treat many patients with Crohn’s disease and
ulcerative colitis. Like many of their colleagues, they were trying to
understand why there has been a dramatic explosion in the number of patients
with Crohn’s disease and ulcerative colitis. They had observed that not only
were these autoimmune GI diseases were on the increase but all autoimmune
diseases were increasing at a dramatic rate in the industrialized world
primarily, North America and Europe. They developed this idea that instead
of something from the outside like an environmental factor was causing this
rise in incidence of autoimmune diseases that maybe it was something now
missing from these patients. So their hypothesis, the “hygiene hypothesis”,
simply states that because we are so clean, in other words very good hygiene
practices, that we never get exposed to helminths that we might lack a key
immune regulatory factor. In fact, if you look at other parts of the world
where the incidence of autoimmune disease is very low and steady, it
overlaps where natural intestinal helminth infections are common.
CEOCFO: Where is Coronado in its human trials?
Dr. Sandage: The previous studies in Crohn’s disease, ulcerative colitis has provided phase 2 efficacy data. The multiple sclerosis trial also provided early phase 2 efficacy. These data provided us with a significant clinical database that allowed us to open an IND with the FDA. We have initiated a phase 1, single dose, dose escalation study which we anticipate completing in the first quarter of 2012 and then hope to start our own Phase 2 Crohn’s study some time in the second quarter of next year.
CEOCFO: Are there any other biotech companies that are trying this approach or are you the only one?
Dr. Sandage: No, not that we are aware. However, there are individual investigators that are studying the mechanisms of how other helminths might work for treating autoimmune disease. For example, there is a group in the U.K. that has been studying the mechanism of action of the hookworm. There are several problems with the hookworm. First, unlike TSO which is taken orally, the hookworm has to penetrate the skin to get into the gastrointestinal tract. Secondly, it is a human pathogen, so it actually causes disease in humans, whereas the pig whipworm does not. We don’t think this application has any commercial utility. As I mentioned before, TSO is really the ideal product and we do not know of anyone else that it is doing any work regarding a commercial application and our patents are pretty broad. We actually cover a range of other helminths and a many autoimmune diseases.
CEOCFO: Are there any other products on the market that have been successful in Crohn’s or is this an area that there is such a great need and nothing else has really worked that it has made a difference.
Dr. Sandage: There are other drugs on the market to treat Crohn’s disease. However, the ones that are well tolerated have limited efficacy and the ones that work well have seriously toxicities, such as steroids and the TNF alpha Inhibitors or the monoclonal antibodies; drugs like Humira and Remicade®. They work, but because they are immunosuppressive agents, they can dramatically suppress the immune system. The patients and doctors worry about the development of serious infections and cancers. In addition, many patients are also faced with the real prospect of requiring abdominal surgery and they end up with colostomy bags. It is a terrible disease, so there is clearly room for a safe, effective orally active product to help these patients.
CEOCFO: So this is clearly an area of unmet need?
Dr. Sandage: It clearly is an area of unmet need. Our KOLs, our key opinion leaders and thought leaders in this area believe that this has real potential. If the studies continue to show similar effects as has bee observed then they believe TSO could eventually become first line therapy; especially because it is so easy to administer and it appears to be very safe. The side effects are limited to mild diarrhea and GI cramping that lasts for a few days. It occurs in about a third to one-half the patients and it seems to go away with continued dosing.
CEOCFO: What is the potential market size for Coronado’s TSO product?
Dr. Sandage: We have not completed a large-scale market research study yet, but I will provide you two pieces of information. In a NIH survey conducted a few years ago, they found that 5% to 8% of the U.S. population, which is tens of millions of people, has an autoimmune disease. We do not know if it going to work in every autoimmune disease but we believe that it has enormous potential. The current size of ulcerative colitis, Crohn’s disease and multiple sclerosis in market is about $9 billion.
CEOCFO: Would you tell us about your NK (natural killer cells) technology, and where are you in the clinical studies?
Dr. Sandage: In your body there are a group of cells called natural killer cells and they make up about anywhere from 5% to 10% of your white blood cells. They are part of what is known as the innate immune system, so they are there for two reasons. One is that you have cells turning over in your body all the time and sometimes you get a mutant cell and the NK cells job is to identify that abnormal cell and kill it before it grows into a cancer. The other feature is it kills cells infected with a virus. However, what happens is that as you age, you get defects in the system, either they do not work as well as they used to or the cancer gets a foothold and tricks the NK cells in not being able to recognize it. In other words, your NK cells lose their ability to recognize the aberrant cells or they just do not work as well as they once did. In simple, terms they just were not activated in a way to be effective any longer. A group at the National Cancer Institute in the early 1980’s came up with a method to activate NK cells. They would separate the NK cells during an apheresis process. They then would incubate these isolated NK cells with Interleukin II (IL-2) outside the body and then infuse them back into the patient. These activated NK cells would then be able to kills aberrant cells again. One issue with this method was to keep the NK cells activated they had to infuse IL-2 in to the patient following reintroduction of the activated NK cells. Unfortunately, IL-2 can have significant toxicity. Since this initial discovery that activated NK cells can treat cancer, specifically minimal residue disease many researchers have been searching for a method to activate these NK cells outside the body without having to use IL-2. We now believe that Dr. Lowdell has discovered a method to activate NK cells without the use of IL-2 by using CDNO-109. Dr. Lowdell’s discovery is a tumor cell line that when incubated with NK cells activate them without IL-2.
CEOCFO: Going forward will this be like an adjuvant or something you are doing in conjunction with other chemotherapies or will this be a stand-alone product?
Dr. Sandage: It is not technically an adjuvant, but this therapy is not designed to be used alone. It is anticipated that the patient will be treated with the prescribed chemotherapy and then treated with the activated NK cells. Because of the nature of the NK cell treatment we think it might have utility in many cancers and in fact have laboratory data showing efficacy in multiple myeloma, ovarian cancer, breast cancer and prostate cancer.
CEOCFO: How is Coronado Biosciences situated financially to move your products into the trials and will you have to raise funds at this point or are you ok?
Dr. Sandage: We took a very unusual route to becoming public. Traditionally companies do IPOs or reverse mergers to get their companies public. We had completed three private rounds and raised $65 million to-date. The last round was completed in late June for $26 million. We had had evaluated various routes to get the company public. In the end we decided to go public through a self-registration process. We first filed a Form-10 and after approval by the SEC became a public reporting company in the middle of September. Then a potential market maker filed a Form-211 to allow us to list on the OTC Bulletin Board. At the same time we filed an S-1 to register all of our private shares. The S-1 went effective and we started trading on the OTC Bulletin Board, in the middle of November. On that same day we submitted our application to NASDAQ. Four weeks later we were approved by NASDAQ and started trading on Monday, December 19, 2011. As of the end of September we had $27 million should take us toward the end of 2012. Therefore, we are in a very good position going into 2012. The programs are making significant progress, we are a NASDAQ listed company and we executing on our plan.
CEOCFO: Do you spend much time out doing road shows to reach investors?
Dr. Sandage: Yes we do! Again, because we did not do a traditional IPO with a banker assisting with the roadshow, we are doing it ourselves. It is up to us to make sure people hear and understand the story, the potential of the products and the plans for the company. Therefore, we are spending a lot of time on the road meeting with buy-side, sell-side organizations, individual investors and brokers. Just a few weeks ago the first analyst initiated coverage of the company.
CEOCFO: In closing, why should potential investors consider Coronado Biosciences?
Dr. Sandage: I think the best way to sum up Coronado Biosciences, as a potential investment is to review the value proposition. We have two biologics, which are inherently more valuable than a small molecule because of lack of multiple potential generic competitors. Both products address huge unmet medical need markets, one for autoimmune disease potentially addressing up to 5% to 8% of the U.S. population and immunotherapy for cancer. The mechanisms of both of these products are such that they could potentially treat any autoimmune disease or any cancer. The first biologic TSO is oral product taken once every two weeks and already has clinical evidence of efficacy in several important autoimmune diseases and the NK program where we have evidence of efficacy in AML. It also has the potential to treat many other cancers. We have cash in the bank that should take us late into 2012. We think the future is quite promising.
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I think the best way to sum up Coronado Biosciences, as a potential investment is to review the value proposition. We have two biologics, which are inherently more valuable than a small molecule because of lack of multiple potential generic competitors. Both products address huge unmet medical need markets, one for autoimmune disease potentially addressing up to 5% to 8% of the U.S. population and immunotherapy for cancer. The mechanisms of both of these products are such that they could potentially treat any autoimmune disease or any cancer. The first biologic TSO is oral product taken once every two weeks and already has clinical evidence of efficacy in several important autoimmune diseases and the NK program where we have evidence of efficacy in AML. It also has the potential to treat many other cancers. We have cash in the bank that should take us late into 2012. We think the future is quite promising. - Dr. Bobby W. Sandage Jr., Ph.D.
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