New Immunotherapy Candidate receives FDA Fast Track Designation

Cell Medica’s Orphan Drug CMD-003 has received fast track designation by the FDA to advance immunotherapy of  patients with Epstein Bar Virus (EBV)-associated malignancies.

The FDA’s fast track designation has been designed to facilitate and accelerate the development of drugs which fill a major unmet medical need. It has now been granted to Cell Medica’s lead EBV immunotherapy candidate CMD-003 to address the need of patients with EBV-associated relapsed/refractory lymphoma and post-transplant lymphoproliferative disease. 

The UK-based biotech company Cell Medica is developing cell-based immunotherapeutic strategies for the treatment of cancer as well as viral infections. EBV infects over 90% of the population usually causing a latent infection. However, EBV-infection is connected to a variety of cancers including 15% – 20% of lymphomas, more than 90% of nasopharyngeal carcinomas and about 10% of gastric cancers.


Cell Medica’s lead product CMD-003 was developed in collaboration with the Center for Cell and Gene Therapy (CAGT) at Baylor College of Medicine and consists of patient-derived (autologous) EBV-specific T cells, targeting four EBV-associated antigens. The patient’s autologous T cells are activated, expanded and finally returned to the patient to recognize and kill EBV-infected malignant cells.


Principle of autologous T cell immunotherapy with CMD-003

CMD-003 is currently being investigated in the Phase II CITADEL trial for patients with extranodal natural killer T cell lymphoma (ENKTCL). Moreover, the company has recently expanded indications to include EBV-positive diffuse large cell lymphoma (DLBCL), Hodgkin lymphoma and post-transplant lymphoproliferative disease (PTLD), which are being investigated in the CIVIC phase II trial.

Recently, CMD-003 received orphan drug designation from both FDA (EBV-associated non-Hodgkin lymphoma) and EMA (extranodal NK/T lymphoma, nasal type and post-transplant lymphoproliferative disease). The orphan-drug designation already paves the road for accelerated marketing approval and extended market exclusivity. Now CMD-003 receives another boost from the FDA, as the fast track status will allow for more frequent interactions with the FDA review team and a rolling Biologics License Application (BLA) for earlier product review.

Cell Medica’s EBV immunotherapy addresses a rare medical condition. However, other T-cell players such as Atara Biotherapeutics in the US are also in the race. The US Biotech is conducting phase II trials with donor-derived (heterologous) cytotoxic T cells for the treatment of EBV-associated malignancies. They have recently received breakthrough therapy designation by the FDA – involving all fast track features – for the treatment of EBV-associated lymphoproliferative disease.

Still, the current status is great news for Cell Medica, who has also recently entered a collaboration with University College London to develop even more innovative T cell receptor products for the treatment of cancer.

Images via / Juan Gaertner and Cell Medica

Support good journalism, subscribe to Labiotech Insider

Labiotech Insider

If you liked this post and want to read more good journalism, support us by joining Labiotech Insider. Our Insider membership gives you access to exclusive content and other advantages.