True North’s Lead Product Candidate, TNT009, Demonstrates High Response Rates and Rapid Onset of Action in Interim Clinical Data in Patients with Cold Agglutinin Disease (CAD)
Data from Ongoing Phase 1b Clinical Study Presented at 21st Congress of the European Hematology Association in Copenhagen
South San Francisco, CA, June 11, 2016— True North Therapeutics, a clinical stage biotechnology company developing novel therapies that selectively inhibit the Complement system to treat rare diseases, today announced new clinical data for its lead product candidate, TNT009, which showed encouraging initial results for the first Cold Agglutinin Disease (CAD) patients dosed in the ongoing Phase 1b study. These interim data demonstrated a concordant improvement of blood parameters with rapid onset of action in patients with CAD, a form of hemolytic anemia in which autoantibodies target and destroy red blood cells. The data are being presented in a late-breaking oral presentation at the 21st Congress of the European Hematology Association (EHA) in Copenhagen. 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.
“These data are highly encouraging and demonstrate proof-of-concept of TNT009 in CAD patients, as well as support the novel mechanism of action of targeting C1s. We are moving expeditiously to complete the Phase 1b study, as we continue along our path for planning an upcoming pivotal study of TNT009 in Cold Agglutinin Disease,” said Nancy Stagliano, PhD, Chief Executive Officer of True North.
“The improvements in blood parameters observed in the initial patients with Cold Agglutinin Disease treated with TNT009 in this study were clinically meaningful and among the most robust I have seen in this disease. This well-tolerated and effective drug candidate could provide an extremely promising approach to the treatment of patients with Cold Agglutinin Disease, a challenging disease for which there are no approved treatment options,” said Ulrich Jäger, MD, of the Medical University of Vienna.
In an oral presentation titled “The Anti C1S Complement Antibody TNT009 Induces Rapid Complete Remissions of Anaemia in Patients with Primary Cold Agglutinin Disease,” Prof. Ulrich Jäger described interim data from the ongoing Phase 1b clinical study demonstrating robust activity of TNT009 in patients with CAD. The data reported on the first five CAD patients dosed in the study, each receiving an initial dose of 10 mg/kg of TNT009 followed by a full dose of 60 mg/kg 1-4 days later, and three additional weekly doses of 60 mg/kg. Four of these five CAD patients in the study responded to TNT009 within the first 24 hours, and of the four responders, three patients achieved a Complete Response (hemoglobin > 12 g/dL) after the 4-week dosing period. In addition, TNT009 was observed to be well-tolerated without need for premedication, and no serious, drug-related adverse events occurred in these study subjects.
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 thrombosis. The prevalence of primary CAD is approximately twenty 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.
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 disease in hematology. Because numerous other diseases are known to share the basic underlying mechanism addressed by TNT009, the potential for other indications is clear.
About True North Therapeutics
True North Therapeutics is a clinical stage biotechnology company developing a pipeline of novel therapies that selectively target the Complement pathway of the immune system to address fundamental mechanisms in rare diseases with high unmet need. The company’s lead 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 antibody drug development is focused on the treatment of rare diseases mediated by the Complement system in hematology, transplantation, and dermatology. True North Therapeutics is located in South San Francisco, California. For more information, please visit www.truenorthrx.com.
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