Life Science Compliance Update

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January 28, 2013

More Industry Academic Alliances

Drug development lab
We recently covered Twenty Industry-Academic Alliances in 2012.  In the past, we have also written extensively about other physician-industry and academic-industry collaborations.  After running our recent story, we came across several other alliances, discussed in further detail below, and will continue to cover such collaborations as they occur.   

GlaxoSmithKline and University of Texas, MD Anderson Cancer Center

GlaxoSmithKline (GSK) recently announced that it has gained rights to a preclinical program from the renowned MD Anderson Cancer Center, in a pact focused on antibodies that trigger immune attacks against cancer.  It’s the first major pharma deal for the center's Institute for Applied Cancer Science (IACS), which was set up last year to operate as a translational research unit that is akin to “a biotech embedded” in an academic setting, a spokesman for the center said in an email.

The prized antibodies in the deal act on OX40 receptors on T cells, helping the ninjas of the immune system recognize tumor cells as enemies in need of an ass kicking.  Like all preclinical programs, the merits of the therapies must pass some initial tests before they advance to human clinical studies.  MD Anderson’s immune-triggering antibodies emerged from the research of Yong-Jun Liu, M.D., Ph.D., and colleagues when he was professor and chair of MD Anderson's Department of Immunology.  He’s since moved on to become the chief scientist of the Baylor Research Institute in Dallas.

Malignant cells are an abnormality that usually attracts a response from the body’s immune system, yet cancer often survives by evading or thwarting anti-tumor immunity.  Consistently unleashing the power of the immune system against cancer would be a major step forward for cancer patients.

T cells are lymphocytes, a type of white blood cell produced by the thymus, equipped with receptors that recognize and bind to antigens, which may include abnormal cells.  “T cell recognition of a tumor antigen is not enough to activate the T cells against cancer cells, they need a secondary signal to tell them 'that antigen you have is a bad thing, you have to attack,’” said Liu.

OX40 is one of these secondary or co-stimulatory receptor proteins. Liu and colleagues found that when it’s activated, it enhances immune attack and blocks suppressors of immune response.  Liu and his MD Anderson colleagues generated and screened hundreds of antibodies that could potentially act as on switches for OX40 by mimicking its natural activator, OX40L, a molecule that binds to OX40. Years of research narrowed the candidates to a handful of activators, or agonists, which were tested in mice and then altered for human use.  Initial clinical trials will occur only after necessary preclinical drug development conducted under the agreement succeeds.

 “This agreement is not only a tribute to the ability of MD Anderson scientists to discover new targets and potential therapies against those targets for cancer patients, it's also a testament to the vision shared by GSK and MD Anderson that successful clinical development of oncology drugs requires seamless integration of drug development expertise and deep biological knowledge,” said Giulio Draetta, M.D., Ph.D., IACS director. “The IACS was formed to enable precisely such integration to expedite the accurate translation of great science into drugs.”

The overall potential value of the agreement to MD Anderson over the life of the agreement is estimated at more than $335 million. Under the terms of the agreement, MD Anderson will receive an upfront license payment and funding for IACS research collaboration activities, as well as payments for reaching development, regulatory and commercial milestones.  In addition, MD Anderson will also be entitled to royalties deriving from the commercial sales of products developed under the collaboration.

“We’re excited about this opportunity with GSK to improve cancer treatment,” Draetta said. “The IACS is a drug development engine with industry-seasoned scientists embedded in a comprehensive cancer center, and as such is ideally suited for this type of collaboration.”

The institute is a vital platform resource for MD Anderson’s recently announced and unprecedented Moon Shots Program, which focuses resources and diverse expertise to significantly reduce mortality in the short term and promote cures long term, beginning with eight inaugural cancers.  “It’s gratifying to see MD Anderson and GSK take this important step towards translating a basic science discovery into a potential new therapy that can proceed to clinical trial,” Liu said.

StemBANCC 

Roche and the Innovative Medicines Initiative (IMI) launched StemBANCC, a new academic–industry partnership that unites ten (10) pharmaceutical companies and 23 academic institutions. Initiated and coordinated by Roche and managed by Oxford University, StemBANCC aims to use human induced pluripotent stem cells as research tools for drug discovery with the goal of using this new technology to develop human disease models and enhance drug development. 

“The aim of StemBANCC is to generate and characterize 1,500 high quality human induced pluripotent stem cell lines derived from 500 patients that can be used by researchers to study a range of diseases including diabetes and dementia,” explained Martin Graf, head of the stem cell platform and coordinator of the project.  “The cell lines will help implement patient models that will facilitate the drug development process thanks to the possibility of reproducing the disease mechanism in vitro.”  The ten companies include: 

  • F. Hoffmann-La Roche Ltd, Basel, Switzerland
  • Abbott GmbH & Co KG, Wiesbaden-Delkenheim, Germany
  • Boehringer Ingelheim International GmbH, Ingelheim, Germany
  • Eli Lilly, Hampshire, United Kingdom
  • Janssen Pharmaceutica NV, Beerse, Belgium
  • Merck KGaA, Darmstadt, Germany
  • Novo Nordisk A/S, Bagsværd, Denmark
  • Orion Corporation, Espoo, Finland
  • Pfizer Limited, Sandwich, UK
  • Sanofi-Aventis Research and Development, Chilly-Mazarin, France 

The StemBANCC project will focus on peripheral nervous system disorders (especially pain), central nervous system disorders (dementias), neurodysfunctional diseases (migraine, autism, schizophrenia, and bipolar disorder), and diabetes. The project will also investigate the use of human induced pluripotent stem cells for identifying drug targets and biomarkers, screening potential drug treatments, and toxicology testing. 

The research resulting in the creation of the first induced pluripotent stem cells was a major scientific advance by scientists John Gurdon (Cambridge University) and Shinya Yamanaka (Kyoto University) who were awarded the 2012 Nobel Prize in Physiology or Medicine.  Most adult cells can only divide to produce other cells of the same type.  For example, skin cells can only make other skin cells, and liver cells can only make other liver cells.

However, in recent years researchers have developed a way of reprogramming ordinary adult cells to create stem cells that can be used to generate any kind of cell.  These induced pluripotent stem cells offer a supply of different kinds of human cell such as cardiomyocytes, endothelial cells, or neurons that can be used for a broad range of in vitro tests in research and early-stage drug development. 

Because these cell lines are derived directly from real patients, they include the genes that may be implicated in diseases of interest.  Moreover, such cell lines have the advantage of being developed from samples that have been obtained from accurately screened and defined groups of patients.  Having a solid database with numerous patients and accurate data on their disease is expected to enable a new level of insight into the disease mechanisms. 

Roche scientists recognized the potential of induced pluripotent stem cells more than three years ago.  Since then they have worked with partners at Harvard University, Massachusetts General Hospital, and Boston Children’s Hospital to create over 100 human induced pluripotent stem cell lines that can be used to model cardiovascular and neurological diseases. 

According to ReportsnReports.com, induced pluripotent stem cells (iPSCs) are now sold by 53.4% of U.S. research product companies and 38.7% of research product companies worldwide. Annual growth in the number of iPSC research products sold worldwide is growing at a rate of 14.7% per year.  In addition, 22% of all stem cell researchers now report having using iPSCs within a research project.  The 23 universities research organisations, public bodies, non-profit groups include: 

  • University of Oxford, Oxford, UK
  • Charité - Universitätsmedizin Berlin, Berlin, Germany
  • Hebrew University of Jerusalem, Jerusalem, Israel
  • Helmholtz Zentrum München - Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH). Neuherberg, Germany
  • Institut National de la Santé et de la Recherche Médicale, Paris, France
  • King’s College London, London, UK
  • Linkopings Universitet, Linköping, Sweden
  • Medical Research Council UK, Swindon, UK
  • Medizinische Hochschule Hannover, Hannover, Germany
  • Medizinische Universität Innsbruck, Innsbruck, Austria
  • Naturwissenschaftliches und Medizinisches Institut an der Universität Tübingen, Reutlingen, Germany
  • Region Hovedstaden - Capital Region of Denmark, Hillerød, Denmark
  • Tel Aviv University, Tel Aviv, Israel
  • Universitätsklinikum Schleswig-Holstein, Lübeck, Germany
  • Université de Genève, Geneva, Switzerland
  • Université de Lausanne, Lausanne, Switzerland
  • Université de Technologie de Compiègne, Compiègne, France
  • University College London, London, UK
  • University of Birmingham, Birmingham, UK
  • University of Cambridge, Cambridge, UK
  • University of Edinburgh, Edinburgh, UK
  • University of Lübeck, Lübeck, Germany
  • University of Newcastle upon Tyne, Newcastle upon Tyne, UK 

Joslin Diabetes Center and Sanofi 

In addition, last spring, Joslin Diabetes Cente,r a teaching and research affiliate of Harvard Medical School, and Sanofi Aventis, announced a new collaboration to promote the development of new medicines for the treatment of diabetes and related disorders.  The collaboration was unveiled at the 2012 Bio International Convention in Boston, Mass. by Dr. Elias Zerhouni, President of Global R&D of Sanofi.  This broad alliance between Joslin and Sanofi spans four significant R&D areas of diabetes and complications aimed at new drug discovery and advancing treatment effectiveness in patients.  

Building on Joslin’s experience in diabetes research and care, the collaboration will focus on four key areas within diabetes and related metabolic disorders to identify potential new biologics or small drug candidates for the treatment of late complications of diabetes and new insulin analogs with more targeted efficacy.  Additionally, research will address the challenges of insulin resistance and personalized medicine, with the overall aim of improving the lives of people living with diabetes. 

Dr. Elias Zerhouni , President, Global R&D, Sanofi, commented: "This collaboration brings together two important forces in diabetes therapy – Sanofi Diabetes and Joslin Diabetes Center – which have the potential to define new pathways towards better understanding the nature of this disease and developing new treatments. This collaboration further demonstrates Sanofi's commitment to improving diabetes management and care through the development of innovative research strategies."

Under the terms of the agreement, Sanofi has options to commercialize the results of the research.  Both parties will have access to intellectual property for internal research use. 

C. Ronald Kahn , M.D., Mary K. Iacocca Professor of Medicine at Harvard Medical School and Chief Academic Officer of Joslin Diabetes Center, who will head the alliance team, added: "This opportunity brings together experts from the pharmaceutical industry with our team of scientists and clinicians, who are devoted to research and clinical care for diabetes and related metabolic disorders. The result should be a very exciting collaboration with great potential for innovative research that will participate to advance diabetes treatment and patient care."



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