True North Provides Corporate Update at J.P. Morgan Healthcare Conference

Accelerates Development of TNT009 in Patients with Cold Agglutinin Disease (CAD) Based on Encouraging Clinical Data

Highlights Potential for TNT009 in Other Rare Diseases including non-Hematologic Indications

Strengthens Management team with Appointment of Gary Patou, M.D. as Chief Medical Officer and Adam Rosenthal, Ph.D. to Chief Business Officer

SOUTH SAN FRANCISCO, Calif.--()--True North Therapeutics, a clinical stage biotechnology company developing novel product candidates that selectively inhibit the Complement system, announced today that the company is expanding its development plan for TNT009, a first-in-class anti-C1s monoclonal antibody. Based on recently presented interim clinical results for TNT009, in which normalization of hemoglobin levels were observed in patients with Cold Agglutinin Disease (CAD), True North will seek to open additional clinical studies in the U.S. and Europe in this rare form of autoimmune hemolytic anemia, and consider developing TNT009 in additional Complement-driven rare disease indications. The company also announced the appointment of Gary Patou, M.D., as Chief Medical Officer and Adam Rosenthal, Ph.D., to Chief Business Officer. An update of the company’s overall development plan for TNT009 will be presented by Nancy Stagliano, Ph.D., CEO of True North Therapeutics, at the 35th Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2017 at 11:00 a.m. in San Francisco.

“TNT009 has demonstrated robust Phase 1b clinical data in patients with CAD and proof-of-pharmacology with an encouraging safety and tolerability profile across several diseases”

“TNT009 has demonstrated robust Phase 1b clinical data in patients with CAD and proof-of-pharmacology with an encouraging safety and tolerability profile across several diseases,” said Nancy Stagliano, PhD, Chief Executive Officer of True North Therapeutics. “Given the unifying biology of diseases mediated by the Classical Complement pathway, we intend to expand the development of TNT009 and leverage the potential for TNT009 to be a ‘pipeline in a product.’”

TNT009 selectively inhibits the Classical Complement pathway by targeting C1s, a serine protease within the C1-complex in the Complement pathway of the immune system. Positive interim results from the ongoing Phase 1b study of TNT009 demonstrated normalization of hemoglobin levels in patients with CAD and were presented in December 2016 at the American Society of Hematology (ASH) annual meeting. In 2016, True North received Orphan Drug Designation for TNT009 from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

“This is also a great time to fortify our management team with the addition of Gary Patou to serve as Chief Medical Officer and the promotion of Adam Rosenthal to Chief Business Officer,” Dr. Stagliano continued. “Gary’s significant experience in biopharmaceutical clinical development in rare diseases and across major therapeutic areas will be instrumental to execute on our clinical programs and realize the full potential of TNT009 for patients across a range of challenging diseases. Adam has been a part of the management team since True North’s founding and previously served as Vice President of Corporate Development. We look forward to his further contributions in this new role as True North continues to grow and evolve.”

Dr. Patou holds the position of Managing Director at MPM Capital, a venture capital fund focused on life sciences companies, and has served in this role since 2005. In addition to his position as Chief Medical Officer at True North Therapeutics, Dr. Patou also serves as Head of Clinical for the biopharmaceutical company Chiasma, Inc., on a limited basis. Previously, Dr. Patou was Chief Medical Officer for Pacira Pharmaceuticals (NASDAQ: PCRX), Chief Medical Officer at Peplin, Chief Medical Officer of Cerimon Pharmaceuticals, and Executive Vice President and Chief Medical Officer of Oscient Pharmaceuticals just after its merger with GeneSoft Pharmaceuticals. Before GeneSoft, Dr. Patou worked at SmithKline Beecham Pharmaceuticals, now a unit of GlaxoSmithKline, as Senior Vice President and Director, Project and Portfolio Management, managing the company’s pharmaceutical development projects. He also serves on the board of directors at Xenon Pharmaceuticals (NASDAQ: XENE). Dr. Patou has held a number of academic appointments at University College & Middlesex School of Medicine, and he received a B.Sc. from University of London and an M.D. from University College London.

About Cold Agglutinin Disease (CAD)
CAD is an autoimmune hemolytic anemia in which autoantibodies target and destroy red blood cells, causing anemia, fatigue and potentially fatal thrombotic events. The prevalence of primary CAD is approximately sixteen per million. There are limited treatment options available and many of these patients, despite therapy, have moderate to severe anemia. True North sponsors a patient registry for CAD and other autoimmune hemolytic anemias, called the COMPASS Registry (https://www.compassregistry.org/), dedicated to advancing a deeper understanding of these diseases, engaging with patients, and supporting clinical trial recruitment.

About TNT009
TNT009 is a first-in-class monoclonal antibody that selectively inhibits the Classical Complement pathway by targeting C1s, a serine protease within the C1-complex in the Complement pathway of the immune system. TNT009 thereby prevents 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 while maintaining the important immune surveillance provided by the Alternative Complement Pathway and Lectin Complement Pathway. TNT009 is currently in clinical development for the treatment of Cold Agglutinin Disease (CAD), a rare hematological disease and three other rare diseases. TNT009 has the potential to address indications in addition to CAD because numerous other diseases are known to share the basic underlying pathological mechanism addressed by TNT009.

About True North Therapeutics
True North Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of first-in-class product candidates for Complement-mediated diseases. The company’s lead product candidate, TNT009, is designed to selectively inhibit a target in the Classical Complement pathway. True North’s antibody drug development is focused on the treatment of certain rare diseases mediated by the Complement system. True North Therapeutics is located in South San Francisco, California. For more information, please visit www.truenorthrx.com.

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Release Summary

Based on clinical results for TNT009, in which normalization of hemoglobin levels were observed in patients with Cold Agglutinin Disease (CAD), True North will accelerate and expand development.

True North Therapeutics