London, UK-based Cell Medica has received European Commission orphan drug designations for its lead cancer immunotherapy CMD-003 (baltaleucel-T).
The designation relates to the treatment for extranodal NK/T-cell lymphoma, a rare type of non-Hodgkin lymphoma, and post-transplant lymphoproliferative disorder, a condition caused by B-cell proliferation due to therapeutic immunosuppression after organ transplantation.
CMD-003 is made of the patient’s immune cells which have been activated to kill malignant cells expressing antigens associated with the oncogenic Epstein Barr virus (EBV).
According to Cell Medica, is therapy has the potential to address a range of EBV-associated lymphomas, nasopharyngeal carcinoma and gastric cancer; the EU orphan designation will provide the firm with regulatory and financial incentives for developing and marketing CMD-003, along with a ten-year period of marketing exclusivity after product approval.
“CMD-003 is a novel cellular immunotherapy with the potential to transform the way we treat patients with EBV-associated lymphomas. We are now testing this product in our CITADEL Phase II trial for patients with advanced extranodal NK/T cell lymphoma and look forward to completion of the study next year,” noted Gregg Sando, Cell Medica’s chief executive.
The therapy picked up orphan status in the US in March.
