IDM PHARMA CONFIRMS WILL SUBMIT NDA FOR JUNOVAN

IDM Pharma has provided an update regarding its plans for Junovan, the company's investigational immunotherapy for the treatment of osteosarcoma, a bone cancer that occurs predominantly in adolescents and young adults.

The company recently had a pre-NDA meeting with the FDA regarding plans to submit a new drug application (NDA) for Junovan. Based on current preclinical and clinical information about Junovan, the company plans to submit the NDA for Junovan later this year.

Junovan is a liposomal formulation of MTP-PE (muramyl tripeptide phosphatidylethanolamine) specifically designed for in vivo targeting of macrophages by intravenous infusion. It is a fully synthetic derivative of muramyl dipeptide, a naturally occurring component of bacterial cell walls. Junovan has been evaluated in Phase II and Phase III clinical trials for the treatment of osteosarcoma.