MedImmune files IND for MT103 with US FDA

The USA's MedImmune has filed an Investigational New Drug application with the Food and Drug Administration for MT103 (also known as MEDI-538) for the treatment of patients with B-cell-derived non-Hodgkin's lymphoma not eligible for curative therapy. According to the firm, the recombinant single-chain bispecific T-cell engager, or BiTE drug candidate, targets the CD19 antigen, which is uniquely expressed on B cells.

Dirk Reitsma, vice president, of clinical development at MedImmune oncology, noted that the specific targeting of T-cells against tumor cells by MT103 represents a "new approach to cancer therapy with potential benefits for patients suffering from certain lymphomas and leukemias, particularly those who have not responded to previous therapies." He added that, "pending FDA review, we plan to begin dosing patients soon in a Phase I study designed to extend the clinical progress made to date in European studies by our partner, Micromet AG."

The German firm, a wholly-owned subsidiary of USA-based Micromet Inc, entered an agreement with MedImmune in 2003 to jointly develop the agent. Under the terms of their collaboration deal, Micromet will receive an undisclosed milestone payment from MedImmune due to the IND filing.