Theraclone Sciences reports positive phase 1 trial results for influenza A antibody

Theraclone Sciences, Inc., a Seattle-based therapeutic antibody developer, announced positive top-line data from its phase 1 trial of a broadly protective, fully human monoclonal antibody meant to treat infections of influenza A.

The company found that the antibody, TCN-032, had no dose-limiting toxicities, was well tolerated throughout the study and exhibited a favorable profile for immunogenicity. The trial was supported partly by a multi-year research and development agreement between Zenyaku Kogyo Co., Ltd., and Theraclone to identify essential conserved antibody targets and develop candidates for treating severe and pandemic seasonal influenza.

"TCN-032 is a therapeutic antibody drug candidate discovered with our I-STARTM platform, and we are extremely pleased with the safety and pharmacokinetic profile and lack of immunogenicity generated from its Phase 1 trial," Eleanor Ramos, Theraclone's chief medical officer, said. "Based on these data, we are confident moving forward to the next step in the development of TCN-032, a Phase 2 influenza viral challenge trial to be conducted in human subjects."

The placebo-controlled, double-blind, randomized phase 1 study enrolled 40 healthy adult volunteers in five single dose cohorts of TCN-032 that escalated from one milligram per kilogram to 40 milligrams per kilogram. No antibodies were detected against TCN-032. The antibody also showed pharmacokinetic parameters that were consistent with other human antibodies. The results from the trial will be presented during an upcoming scientific conference.