US FDA grants fast-track designation to Cell Medica's CMD-003

The US Food and Drug Administration (FDA) has granted fast-track designation to UK-based cellular immunotherapy firm Cell Medica's oncology product CMD-003 (baltaleucel-T).

The designation includes the treatment of patients with relapsed / refractory lymphoma and post-transplant lymphoproliferative disease (PTLD) associated with the oncogenic Epstein Barr virus (EBV).

CMD-003 is an investigational therapy that activates the T-cells to destroy malignant cells expressing EBV antigens. It also has the potential to treat various EBV-associated lymphomas, nasopharyngeal carcinoma and gastric cancer.

Cell Medica chief medical officer Dr Kurt Gunter said: "The fast-track designation supports the potential for CMD-003 to address an important area of high unmet clinical need.

"The fast-track designation supports the potential for CMD-003 to address an important area of high unmet clinical need."

"The potential eligibility for accelerated approval and priority BLA review will help facilitate the development of our lead cancer immunotherapy candidate."

CMD-003 has also secured orphan drug designations from the FDA for EBV-associated non-Hodgkin lymphoma, as well as from the European Commission for extranodal NK/T lymphoma, nasal type and PTLD.

An international, open-label Phase II CITADEL clinical trial is being conducted to evaluate CMD-003 in extranodal natural killer T-cell lymphoma (ENKTCL) patients.

The firm has also initiated a Phase II CIVIC clinical trial to assess the potential benefits of CMD-003 in EBV-associated diffuse large B-cell lymphoma (DLBCL), Hodgkin lymphoma and PTLD.

Cell Medica develops, manufactures and markets cell-based immunotherapy products using proprietary technology platforms such as activated cytotoxic T-cells, chimeric antigen receptors (CARs) and engineered T-cell receptors (TCRs).