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T cell targets
BOSTON—A three-year research collaboration between global pharmaceutical company Sanofi and Brigham and Women's Hospital, a teaching and research affiliate of Harvard Medical School, will focus on the immunology of type 1 diabetes in an attempt to analyze and develop new drug targets.
"Because diabetes is a major focus of our company, we are always seeking opportunities to develop new medicines for both type I and type 2 varieties of the disease," explains Dr. Srideran Natesan, scientific site head of research and development at Sanofi in Cambridge, Mass., and head of external innovation and partnering for the U.S. northeast region. "Now that we have become a significant presence in the Cambridge area, we are looking for ways to collaborate with top researchers and invite them to make presentations to our diabetes management team."
Sanofi was impressed with the work of Dr. Vijay Kuchroo, a veterinarian and pathologist who serves as professor of neurology at the Harvard Medical School and Wasserstrom professor of neurology and associate immunologist at the Brigham and Women's Hospital, according to Natesan.
"Vijay is a key leader in immunology in type 1 diabetes and has validated several targets in his laboratory," Natesan says. "Eventually, through this collaboration, we will look for new targets and develop them."
Kuchroo's laboratory has made several transgenic mice that serve as animal models for human disease. The major focus of research in the laboratory is to study the autoimmune T cell response, role of costimulatory molecules and their receptors in the induction and differentiation of T cells and identification of cell surface molecules differentially expressed on T cell subsets. Kuchroo's research interests are studying the autoimmune diseases, particularly the role of costimulation, the genetic basis of experimental autoimmune encephalomyelitis or experimental allergic encephalomyelitis, an animal model of brain inflammation and type 1 diabetes and cell surface molecules and regulatory factors that contribute to susceptibility and resistance to autoimmune diseases.
"Brigham and Women's Hospital is excited to engage in this important research collaboration," said Dr. Barbara Bierer, the hospital's senior vice president of research, in a press release. "This strategic collaboration brings further recognition to the outstanding research of Dr. Kuchroo and his colleagues, including Drs. Terry Strom and Maria Koulmanda from Beth Israel Deaconess Medical Center, and the importance of the translation of fundamental discoveries into routine clinical practice."
According to the terms of the collaboration, Sanofi and Brigham and Women's Hospital will share knowledge and apply their respective expertise in basic and applied research regarding diabetes and drug target and candidate development. Researchers from both organizations will undertake proof-of-concept, safety and functional studies for a novel immunomodulatory approach to treat type 1 diabetes, and Sanofi will have an option to exclusively license intellectual property emerging from the collaboration. There will be "milestones on one or two targets" and then "a decision on whether to expand the program," Natesan says.
Internationally acclaimed for its patient care, biomedical research and healthcare professional teaching capabilities, Brigham and Women's Hospital is a 793-bed teaching affiliate of Harvard Medical School. With roots dating back to 1832, the hospital formed in 1980 with the merger of three Harvard teaching hospitals.
Sanofi, which discovers, develops and distributes therapeutic solutions, has established a number of partnerships to offer diagnostics, therapies, services and devices for the prevention and cure of diabetes. After two years of discussions with leaders in universities and research institutions, Sanofi has made plans to ally with other researchers to enhance its own offerings of insulin products. The global and diversified healthcare company recently announced a collaboration with the Joslin Diabetes Center, a clinical, teaching and research affiliate of Harvard Medical School that has 47 affiliated clinics in the United States.
Natesan believes that diabetes is moving toward more personalized medicine and hopes the collaboration between Sanofi and Brigham and Women's Hospital will bring about "a comprehensive strategy to address immunomodulation, which we believe to have a lot of value."
Sanofi and Regeneron launch Phase III cholesterol trial
PARIS—Sanofi also announced last month, along with partner Regeneron Pharmaceuticals Inc., that several trials within ODYSSEY, the Phase III clinical program of SAR236553/REGN727, have initiated patient enrollment.
SAR236553/REGN727 is a potential first-in-class, subcutaneously administered, fully human antibody that lowers low-density lipoprotein (LDL) cholesterol by targeting proprotein convertase subtilisin/kexin type 9 (PCSK9), an enzyme which binds LDL receptors, leading to their accelerated degradation and increased LDL-cholesterol levels.
ODYSSEY, a global program to evaluate SAR236553/REGN727, will consist of more than 10 clinical trials and will include more than 22,000 patients. The studies will be conducted in clinical centers around the world, including the United States, Canada, Western and Eastern Europe, South America, Australia and Asia.
SAR236553/REGN727 is administered as a single injection every two weeks in multiple treatment strategies and patient types, such as those who are at elevated cardiovascular risk, are unable to tolerate statin therapy or have familial hypercholesterolemia.