SOUTH SAN FRANCISCO, Calif. -- (BUSINESS WIRE) -- True North Therapeutics, a biotechnology company developing novel therapies that selectively inhibit the Complement system to treat rare diseases, today announced the appointment of James Gilbert, M.D., as the Company’s first Chief Medical Officer (CMO). As CMO, Dr. Gilbert will oversee all clinical development and regulatory activities for the company, as True North advances its lead product candidate, TNT009, into human clinical trials for autoantibody-driven rare diseases that are mediated by the Complement system.
Dr. Gilbert is a seasoned biopharmaceutical executive with experience moving early stage R&D programs successfully through clinical development and product commercialization. He will report directly to True North’s CEO Nancy Stagliano, Ph.D., and will serve as a member of the company’s executive management team.
“The depth and breadth of Jim’s expertise in advancing and commercializing products for a wide range of indications, including rare hematologic diseases, make Jim an ideal fit for True North,” said Nancy Stagliano, Ph.D., President and Chief Executive Officer of True North Therapeutics. “His proven leadership will accelerate our success as we move forward with our plans to initiate the first human clinical trial of TNT009 in early 2015.”
Dr. Gilbert has more than 25 years of biopharmaceutical industry and medical experience, particularly in managing clinical development of programs in hematology, cardiovascular and inflammatory diseases. During this time, he led and contributed to numerous clinical programs with clinical trials at a wide spectrum of scales, from first-in-human studies with novel drug candidates to Phase 3b/4 trials, advancing drugs successfully from IND through sNDA/sBLA/MAA, including programs in metabolic, inflammation, cardiovascular, and hematology indications at various companies.
“True North’s novel antibodies are designed to selectively target and block upstream processes in the Classical Complement pathway, offering the potential to effectively interrupt Complement-mediated disease processes,” said Dr. Gilbert. “True North’s unique approach clearly opens up tremendous opportunities to meet the unmet needs of patients with rare diseases, and I look forward to working with the True North team to advance the first clinical development of our lead compound, TNT009, as well as additional development programs.”
Prior to joining True North, Dr. Gilbert most recently served as Chief Medical Officer at Cardioxyl and Archemix and as a consulting clinical advisor to a number of life science venture capital firms and privately-held, early-stage biotechnology companies. Prior to these CMO roles, he served as Senior Vice President of Clinical Development for Cardiovascular and Inflammation at Millennium, where he was responsible for early clinical development of Millennium's pipeline of novel immunomodulators and for late-stage development of its marketed cardiovascular product, Integrilin®. Prior to Millennium, he held positions of increasing responsibility over seven years at Boehringer Ingelheim Pharmaceuticals, Inc., including serving as Global Therapeutic Area Head for Cardiovascular and Metabolic Diseases. He also previously worked at Bayer Corporation. Dr. Gilbert received his Doctor of Medicine from the University of Connecticut School of Medicine and his Bachelor's degree from Yale University in Molecular Biophysics and Biochemistry. He did a post-doc in Pharmacology at Columbia University and, before taking a position within the pharmaceutical industry, he was an instructor in the Departments of Medicine and Pharmacology at the University of Connecticut School of Medicine and a staff physician at St. Mary's Hospital in Waterbury, Connecticut.
TNT009 is a first-in-class molecule developed to selectively inhibit C1s, a serine protease specific to the Classical Complement pathway of the immune system. TNT009 selectively inhibits the Classical Complement pathway, thereby preventing downstream disease processes involving phagocytosis, inflammation, and cell lysis. With a unique mechanism of action and high target specificity, TNT009 selectively inhibits disease processes in the Classical Complement pathway cascade while maintaining the important immune surveillance provided by the Alternative Complement Pathway and Lectin Complement Pathway.
About True North Therapeutics
True North Therapeutics is a biotechnology company developing novel therapies that selectively target the Complement pathway of the immune system to address fundamental mechanisms in diseases with high unmet need, including rare diseases. The company’s lead monoclonal antibody drug candidate, TNT009, offers a novel approach for treating Complement-mediated diseases by selectively inhibiting a target in the Classical Complement pathway. True North’s drug development programs are focused on Complement-mediated rare diseases in the hematologic, kidney transplant, dermatology and neurological therapeutic areas. True North Therapeutics is located in South San Francisco, California. For more information, please visit www.truenorthrx.com.