MEDIMMUNE FILES IND APPLICATION FOR LYMPHOMA DRUG

MedImmune has filed an investigational new drug (IND) application with the FDA for MT103 for the treatment of patients with B-cell-derived non-Hodgkins lymphoma (NHL) not eligible for curative therapy. MT103 is a recombinant single-chain bispecific T-cell engager, or BiTE, molecule. It targets the CD19 antigen, which is uniquely expressed on B cells.

In the proposed Phase I open-label, single-arm, dose-escalation, U.S. trial, investigators will assess the safety, tolerability and anti-tumor activity of a continuous intravenous infusion of MT103 in patients with B-cell-derived NHL who have not responded to or have become refractory to other therapies. Other endpoints include MT103's pharmacokinetics, pharmacodynamics and immunogenicity, as well as exploration of the molecule's mechanism of action. Doses will be given for a four-week period, with an option for an additional four weeks of therapy if disease improvement or stabilization is observed.

In February the FDA granted MT103 orphan drug status for the treatment of indolent B-cell lymphoma, excluding chronic lymphocytic leukemia and NHL with central nervous system involvement. The drug also has orphan drug designation in the European Union for the treatment of mantle cell lymphoma and chronic lymphocytic leukemia.