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, presented data today from preclinical efficacy studies of TNT009 for the treatment of Cold Agglutinin Disease (CAD), a rare autoimmune hemolytic anemia, at the 2013 American Society for Hematology (ASH) International Conference in New Orleans. TNT009, the company’s lead monoclonal antibody drug candidate, was shown in preclinical studies to be a potent and specific inhibitor of the Classical Complement pathway and demonstrated the ex vivo ability to prevent Complement deposition, phagocytosis, and hemolysis of red blood cells induced by autoantibodies from CAD patients.
The results presented validate the novel mechanism of TNT009 to selectively inhibit C1s, a serine protease specific to the Classical Complement pathway, and thereby interrupt disease processes at one of the earliest points in the Complement cascade. Based on these and other results, True North plans to file an Investigational New Drug (IND) application for TNT009 with the U.S. Food and Drug Administration in late 2014.
“These studies clearly reveal the potential of TNT009 to meet unmet medical needs of patients with a variety of Complement-mediated autoimmune and inflammatory disorders, in addition to Cold Agglutinin Disease,” said Nancy Stagliano, Ph.D., CEO of True North Therapeutics. “By selectively targeting proximally in the Classical Complement pathway, TNT009 has shown potential to be a first-in-class monoclonal antibody with a novel mechanism of action that could effectively prevent downstream disease processes involving phagocytosis, inflammation, and cell lysis. Encouraged by the success of these studies, we plan to file an IND with TNT009 within the next year.”
Highlights from the oral presentation at ASH included:
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. By precisely targeting the Classical Complement pathway, TNT009 offers a novel approach for treating Complement-mediated diseases with significant unmet medical needs in the hematologic, renal, and neurological therapeutic areas. 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. With preclinical and ex vivo data demonstrating TNT009’s efficacy, True North Therapeutics anticipates initiating the first clinical program with TNT009 in late 2014.
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, selectively inhibits a target in the Classical Complement pathway, thereby preventing downstream disease processes involving phagocytosis, inflammation, and cell lysis. True North’s drug development programs are focused on Complement-mediated diseases in the hematologic, renal, and neurological therapeutic areas. True North Therapeutics is located in South San Francisco, California. For more information, please visit www.truenorthrx.com.