October 28, 2013 Issue
The Most Powerful Name In Corporate News and Information
Induced Pluripotent Stem Cell Platform for Novel Drug Target Discovery
About iPierian, Inc.
iPierian is a biotechnology
company targeting secreted Tau for treatment of Alzheimer’s disease and
other Tauopathies. The company’s lead drug candidate (IPN007) is a
monoclonal antibody targeting a novel form of secreted Tau that is
differentially regulated in Alzheimer’s disease patients, designed to slow
the spread of Tau throughout the brain and therefore inhibit the associated
conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, To be published –
October 28, 2013
CEOCFO: Dr. Stagliano, what is the concept at iPierian?
Dr. Stagliano: The concept at iPierian is to leverage our induced pluripotent stem cell platform to discover novel drug targets and better therapeutics. The company was founded in 2008 when Shinya Yamanaka developed the Nobel Prize winning approach to making adult stem cells. We used that technology and method and developed models of various diseases; most recently in the past two years since I have been the CEO, we’ve capitalized on models of Alzheimer’s disease in a cell culture dish, taking skin cells; fibroblasts, from patients that had Alzheimer’s disease. Through multiple laboratory steps we created adult neurons and understand better what makes the Alzheimer’s neurons different from healthy neurons.
CEOCFO: What is it about the process that is different than what has been tried in the past?
Dr. Stagliano: In particular, in fields like Alzheimer’s diseases and neurodegenerative diseases the industry has suffered quite a bit by the lack of relevant models and the lack of tissues to study. That is because, as you might imagine, people are reluctant to give out pieces of their brain for scientists like me to study. However, they certainly are willing to give up tumors. They certainly are willing to give blood samples. Therefore, other disease areas like oncology and hematology have benefitted from the access to patient tissues. This field, neurodegeneration and Alzheimer’s, has really struggled. For that and other reasons, there are no approved disease modifying drugs for Alzheimer’s disease. Therefore, this approach of making adult stem cells from patients and then studying them, allows us to really have a window into the disease that never could happen before. It is a very relevant window and view into what is happening in these patients’ cells verses what is happening in healthy cells. That is the big difference in the special technology that we are able to leverage to then develop very standard looking drugs, such as antibodies. One of the drugs that we discovered out of this platform is a monoclonal antibody; a large molecule that the industry is extremely used to and is extremely comfortable making and manufacturing. However, we have a novel target and we learned about that target through these cell models.
CEOCFO: What are you targeting? Would you tell us about Tau?
Dr. Stagliano: Tau is the protein that comprises tangles in the Alzheimer’s and other neurodegenerative brains. Alzheimer’s disease patients have plaques and tangles. You have probably heard of those. The Tau protein, we have discovered, is secreted and truncated. It is released from neurons in Alzheimer’s patients at a very high level, compared to the level that it is released in healthy individuals. Therefore, we developed a monoclonal therapeutic antibody to the Tau form that is released, with the idea that if we block its function and remove it from the brain and cerebral spinal fluid (CSF) that we will reduce the progression of Alzheimer’s disease and the spread of Alzheimer’s disease that is thought to be Tau driven.
CEOCFO: Where are you in the process?
Dr. Stagliano: We are in the manufacturing stage of the molecule. We have completed efficacy studies in mouse models of Alzheimer’s. They have shown robust, positive effects. We are working on the manufacturing phase, which will take us into about a year from now, when we will file an IND with the FDA.
CEOCFO: iPierian had a recent funding. What will the funds be used for and how far will it take you?
Dr. Stagliano: A few weeks ago we did announce that iPierian raised thirty million dollars from its existing venture capitalists, insiders. Out of that thirty million dollars come two major milestones. One was the formation of a new company called True North Therapeutics, which is an iPierian spinout. The other is the financing of the Tau antibody through an IND filing and positioning it to get into the clinic. Therefore, the thirty million dollar financing accomplishes two things; getting the Tau antibody into the clinic and spinning out a new company called True North.
CEOCFO: Why the spinout? What is the business concept?
Dr. Stagliano: The spinout was accomplished because we had a second molecule that we discovered using the iPSC platform that I told you about. It is an antibody against a target in the complement pathway. We do not publicly disclose the target. However, suffice it to say that we believe that this molecule would be applicable to a number of orphan diseases and autoimmune diseases. It differed quite a bit from the iPierian strategy of working on Alzheimer’s therapeutics. Although it was discovered again, initially in Alzheimer’s models, the more we studied this target and the more we developed the therapeutic antibody, the more we realized that it had better potential, both clinically and commercially, in ultra orphan diseases of the autoimmune type. Therefore, we thought that that represented a completely different business opportunity, would attract completely different partners and require different capital.
CEOCFO: Has the medical community been paying attention to iPierian or is it too early?
Dr. Stagliano: No, it is not too early! Actually, we have gotten a lot of attention most recently because we have described the preclinical the success of this Tau antibody,in a presentation as well as a press release. Tau is a very exciting and attractive area for pharmaceutical interest and investment right now. Most researchers think that this is a very important mechanism in Alzheimer’s. Therefore, because we have discussed the success in animals with this molecule, because we have described that we are going to have an IND filed next year, we have gotten a lot of attention from pharmaceutical partners.
CEOCFO: What are the next steps?
Dr. Stagliano: At iPierian, in the next year we will continue to study the Tau antibody. We will do the normal studies required for toxicology. We will look at building out a clinical development strategy to define which patients do we begin with – orphan tauopathies such as PSP or Alzheimer’s disease. We will get in front of the FDA in January and have a conversation via a pre IND meeting to discuss our plans. That will be a big milestone for the company. Again, we will continue to advance the manufacturing, so that we are ready to get into the clinic at the end of next year. Our team is poised to continue to study the biology and to develop diagnostic tools and additional biomarker components of the program. We also hope to engage a pharmaceutical partner for this program within the next year.
CEOCFO: You have considerable history in the industry. What you learned that has been most helpful as you are developing iPierian?
Dr. Stagliano: I have learned that you cannot overestimate the value of a strong team and supportive investors. I think that no matter how smart we are and no matter how creative we are, we must always be willing to adapt to the data, adapt to what the science teaches us, adapt to the competition and that your initial plan and your initial vision for where a company might go and what might be the most exciting product is usually not the right one. It is usually not the one that turns out to be the case. Therefore, for me I came in with the goal of developing products. The company had been rooted in a strong platform, but my job was to convert that platform into a product engine. I did not know where the products would come from. I did not know whether they would be for Alzheimer’s or ALS or other diseases. Again, I did not know whether there would be one or ten programs to choose from. However, I think the flexibility of your team and the support of your investors allows you to follow the science and allows you to then get to this place where we have, not just a strong Alzheimer’s program, but a second company.
CEOCFO: Why does iPierian standout for investors and people in the business community?
I think that iPierian
represents a success story, in the sense that we very rapidly converted a
Nobel Prize winning method into viable therapeutic candidates that range
from blockbuster indications like Alzheimer’s disease, to rare hematology
disorders for the True North Company. Again, the iPierian approach, using
adult stem cells to model disease, will represent the first target and
molecule in the clinic that was derived from those types of models, to our
knowledge. We have executed extremely rapidly. I have been with the company
two years and in less than two years we now have two antibodies in
development. We have been working hard here, but it is very exciting.
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