True North’s TNT009 demonstrates high response rates and rapid onset of action in interim clinical data in patients with CAD

Data from ongoing Phase Ib clinical study presented at 21st Congress of the European Hematology Association in Copenhagen.

“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 Ib study, as we continue along our path for planning an upcoming pivotal study of TNT009 in CAD,” said Nancy Stagliano, CEO of True North.

“The improvements in blood parameters observed in the initial patients with CAD 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 CAD, 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 Ib 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.