FDA grants orphan drug status to Cell Medica's CMD-003

The US Food and Drug Administration has granted orphan drug designation to Cell Medica’s lead cancer immunotherapy product CMD-003.

The designation was granted to treat Epstein-Barr Virus-positive non-Hodgkin lymphomas. Cell Medica has also announced the treatment of the first patient in its CITADEL Phase II trial, a clinical study to investigate the safety and efficacy of CMD-003 to treat aggressive extranodal NK/T cell lymphoma where other therapies have proved unsuccessful.

CMD-003 is a cell therapy product comprising T-cells targeted at malignant cells expressing the oncogenic Epstein Barr virus, a ubiquitous virus infecting more than 90% of the human population on a latent basis. The expression of EBV antigens by tumor cells provides the opportunity to use the patient’s immune cells to target and kill the cancer. It is produced from the patient’s T-cells harvested from a blood sample and sent to Cell Medica’s manufacturing site for activation and expansion through a proprietary procedure developed for commercial-scale use.