Intellect Neurosciences Inc. (ILNS-OTCPK)
April 6, 2012 Issue
The Most Powerful Name In Corporate News and Information
Intellect Neurosciences is the Quiet Force Behind the Next Generation of Alzheimer’s disease Therapies
G. Chain, Ph.D.
Dr. Chain formed Intellect
in April 2005 and has served as Chairman and Chief Executive Officer since
October 2005. Dr. Chain was previously the President and CEO of Mindset
BioPharmaceuticals, a private company he founded in 1999.
Dr. Chain is the inventor of
the Company’s ANTISENILIN® technology for the treatment and prevention of
Alzheimer’s disease, which underlies products in Phase 2 and Phase 3
clinical trials by major pharmaceutical companies that have purchased
licenses from Intellect Neurosciences for the commercialization of those
products. Patents in relation to Dr. Chain’s invention have been granted in
Europe, Japan and recently received a Notice of Allowance by the USPTO. Dr.
Chain is also the inventor of a patent concerning the use of insulin
sensitizers for the prevention and treatment of memory loss and dementia and
recently filed two new patents that underlie the newest technology platforms
at Intellect Neuroscience.
Intellect Neurosciences, Inc. develops innovative approaches aimed at arresting or preventing Alzheimer's disease, and other neurodegenerative diseases, focusing especially on proteinopathies. Intellect's pipeline includes therapeutic vaccines, antibodies and neuroprotective antibody drug conjugates.
New York, NY 10018
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – April 6, 2012
Dr. Chain: I have a long interest in Alzheimer’s disease dating back to the mid-1990’s. There was then and remains today a tremendous need for therapies that can slow down or arrest disease progression. In the late 1990’s I came up with a potential therapeutic approach for Alzheimer’s disease and that was really the technology that was the impetus to for starting my first company whose assets were ultimately transferred to Intellect Neurosciences in 2005.
have a very rich patent and technology portfolio. We have patents that date
back to the original invention back in 1997. Today, we have 3 products in
advanced clinical trials of major pharmaceutical companies. They are
developing product independently of Intellect, based on the technology. They
have taken licenses from the company, so we would anticipate receiving
royalties when those drugs eventually reach the market. The most advanced
drug is in Phase III clinical trials and may be on the market by 2014 if
Phase III data is positive. The core competence of the company is based on
using various different antibody based approaches. This includes vaccines
against targets that are important in Alzheimer’s disease, such as beta
amyloid and tau proteins, as well as antibody drug conjugates, where we take
an antibody against these targets and combine them with a small molecule
that has neuroprotective function. We have several programs and platforms at
various different stages of development.
CEOCFO: Would you tell us about your RECALL-VAX™?
Dr. Chain: RECALL-VAX is a platform for generating antibodies, where an antibody is administered externally as a drug. Here the idea is more like a flu shot, with the idea of being able to immunize patients even before disease starts with an antigen that will promote production of antibodies in the bloodstream that eventually get to the brain. This will allow patients to develop their own immune response against these toxic proteins. We have three candidates from RECALL-VAX that are currently being tested in preclinical studies. One of them targets the beta amyloid protein, and the second one an abnormal tau protein. The third candidate is a combination of those two. Our hope is that the method of vaccination will be safe enough to be administered to anybody who is susceptible. It could be somebody who has reached a certain age that is close to the onset of Alzheimer’s disease in the general population, or it could be individuals who carry a particular gene defect or mutations that make them susceptible to develop Alzheimer’s disease.
Dr. Chain: Our key recent recruit is Dr. Dan Shochat, as a vice president for non-clinical development. Dan has thirty years of experience in antibody drug development and especially, he has brought three products all the way through FDA approval. He led the first team that had the first approved antibody drug conjugate for cancer, a drug called Mylotarg. He developed two additional products, so he brings an enormous breadth of experience to the program and we expect them to take the lead in directing this program towards the initiation of clinical trials.
Dr. Chain: We have many exciting things coming up. I should just mention that we have just recently achieved a very important milestone for the company with a patent allowance from the USPTO for the key patents that we have licensed to big pharma. In addition, we expect additional patents related to that technology to issue during the course of the year. Then we have the anticipated completion of Phase III clinical trials on a drug, Bapineuzumab, that is based on our ANTISENILIN platform technology. That data will, hopefully, be available towards the end of the year, or maybe the beginning of next year. That Phase III clinical data is very important, first of all, to validate Intellect core immunotherapy approach. It is also obviously of enormous importance to the community at large. It would be the first disease modifying drug for Alzheimer’s disease and the first new drug approved for Alzheimer’s disease since 2004. There is now a very large trial ongoing that I have to emphasis is being done independently of Intellect. It uses Intellect platform technology, but it is being independently developed and it is a co-development between Pfizer and Johnson & Johnson.
Dr. Chain: The whole model in terms of a biotechnology business has changed dramatically since I started in the late 1990’s and that time most biotech companies would have, first of all, one key technology. They would take it through some initial proof of concept, partner it with a large company, do an IPO and then all of the original founders and shareholders get out at that point and go start another company. That whole model has really disappeared. Today, there are fewer exits for companies and for shareholders. One tends to stay with the development or is linked to the development of the drug all the way through. That is a very different model than the one that we had envisaged. Also, the time for developing a drug as changed. It was at one point a ten-year development and now it is really a fifteen-year development, especially for Alzheimer’s disease. That is really quite challenging if you are starting at ground zero and have to think about that time course before the drug actually makes it through trials. It has been a tremendous learning experience. We have seen the Alzheimer’s field evolve tremendously over this time. There is much more understanding about the fundamental mechanisms involved in Alzheimer’s disease, and there is a lot of clinical trial experience that is making the design of new trials much easier than previously. There are very good biomarkers that are beginning to play, including imaging biomarkers. When we started, we did not think we would see any surrogate markers approved by the FDA within our lifetime and that has changed. In fact, with the new biomarkers, one still relies on a cognitive outcome, but we had made a lot of progress in the field in terms of developing biomarkers that could help facilitate clinical trial design and outcomes. Therefore, there have been very important developments over this period of time.
Dr. Chain: It depends what we want to do. What we would like is progress with the earliest stage programs now that we licensed the IP related to late-stage clinical development. We are focused on these very innovative, but relatively early stage platforms that we believe will generate data to attract additional partnerships over the next year and eighteen months. Therefore, what we would like to do is to raise some additional capital now that will allow us to move forward aggressively with developing those programs.
Intellect is really an extraordinary company with a portfolio that is much
more diverse than other companies in the field are and that really mitigates
the risk for investors. It gives us multiple shots on goal. We have really
shown now that we tend to pick technologies that find favor with major
pharmaceutical companies. We have entered into four agreements with large
companies, royalty bearing with significant milestones and we expect that we
will have several additional partnering opportunities related to these
earlier stage platforms as well. Therefore, we are really unique within the
Alzheimer’s space; a small company with licensed products in Phase II and
III clinical trials. We are addressing the major unmet medical need of
Alzheimer’s disease. We also have gone into the Orphan Drug space with the
licensing of OX1 for Fredrich’s ataxia and we have technologies that could
be applied to several different indications and generate new drugs.
Intellect is really an extraordinary company with a portfolio that is much more diverse than other companies in the field are and that really mitigates the risk for investors. It gives us multiple shots on goal. We have really shown now that we tend to pick technologies that find favor with major pharmaceutical companies. We have entered into four agreements with large companies, royalty bearing with significant milestones and we expect that we will have several additional partnering opportunities related to these earlier stage platforms as well. Therefore, we are really unique within the Alzheimer’s space; a small company with licensed products in Phase II and III clinical trials. We are addressing the major unmet medical need of Alzheimer’s disease. - Dr. Daniel G. Chain Ph.D.
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