Development of Human Anti-Influenza Monoclonal Antibodies for Treatment of Flu

Janessen Vaccines And Prevention, Bv, Leiden

Investigators

Abstract

The overall objectives and scope of this contract is to advance the development of human monoclonal antibody (mAbs) products for treatment of Influenza A viral infections. The scope of work for this contract includes nonclinical, preclinical, and clinical development activities to: (1) perform studies to characterize and validate lead mAbs using in vitro and in vivo approaches;(2) develop manufacturing and formulation processes and analytical testing procedures for lead Flu mAb candidates and manufacture GMP clinical materials;(3) perform enabling activities to file the Investigational New Drug (IND) applications with the Food and Drug Administration (FDA);and (4) perform clinical trials to evaluate the safety, tolerability, pharmacokinetics, and the proof of efficacy in humans of the candidate drug products.