ONO AND MEDAREX PLAN TO BEGIN TRIAL OF CANCER TREATMENT
Ono Pharmaceutical and Medarex have filed an investigational new drug application with the FDA for MDX-1106, a fully human anti-PD-1 antibody for the treatment of cancer.
The Phase I dose-escalation trial will be the first human study of MDX-1106/ONO-4538 and is expected to enroll up to 39 patients with recurrent or treatment-refractory cancer. The study is intended to evaluate the pharmacokinetics and the safety of MDX 1106/ONO-4538. Studies suggest that the PD-1 signaling pathway may play an important role in tumor evasion and escape from host immune responses and may also promote the persistence of certain chronic viral infections. Preclinical studies suggest that antibody blockade of the PD-1 signaling pathway promotes anti-tumor responses and control of persistent viral infections.
Ono entered into a collaboration agreement with Medarex in May 2005 to
research and develop an anti-PD-1 antibody for the treatment of cancer. The two companies plan to share the costs and responsibilities of research and product development up to the completion of a Phase II clinical study.