BioCentury
ARTICLE | Clinical News

TNT009: Interim Phase Ib data

June 20, 2016 7:00 AM UTC

Interim data from 5 patients with cold agglutinin disease (CAD) in Part C of a 3-part, double-blind, Austrian Phase Ib trial showed that a single dose of 10 mg/kg IV TNT009 followed by 60 mg/kg IV TNT009 1-4 days later and once weekly thereafter for 3 weeks led to responses in 4 patients within 24 hours. TNT009 normalized hemolysis-related laboratory parameters after the first dose and repeated dosing led to correction of anemia by the normal hematopoietic process in all responders at a rate of >1 g/dL per week. Three patients who were transfusion-dependent at baseline became transfusion-independent during treatment and 2 of those patients who had been chronically treated with steroids became steroid-free during treatment. Relapse of hemolysis and anemia occurred in all patients 3-4 weeks after the end of treatment. The product was then made available to the patients under a named patient program and re-exposure to TNT009 again led to remission in each of those patients. TNT009 was well tolerated with no treatment-related serious adverse events reported. ...