Ono and Medarex cancer antibody advancing into phase I

The phase I dose-escalation trial is the first human study with MDX-1106 (also known as ONO-4538), a fully human anti-PD-1 antibody for the treatment of cancer, 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.

In May 2005, Ono entered into a collaboration agreement with Medarex to research and develop a fully human 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.

Thereafter, each company will be fully responsible for any continued development and any commercialization in its exclusive territory; Medarex’ exclusive territory is North America, and Ono’s exclusive territory is all areas outside of North America.

“We believe that MDX-1106 is part of an emerging new class of immunopotentiators – antibodies that target immune regulatory pathways, such as CTLA-4 – that are designed to boost a patient’s immune response to eliminate cancer and chronic infection,” said Dr Donald Drakeman, president and CEO of Medarex.