Published 21st February 2017

Cell Medica granted FDA Fast Track designation

Touchstone Innovations plc (AIM: IVO, ‘the Group’, ‘Innovations’) is pleased to note today’s announcement by portfolio company Cell Medica (the ‘Company’) that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company's lead oncology product (CMD-003) for patients with relapsed/refractory lymphoma and post-transplant lymphoproliferative disease associated with the oncogenic Epstein Barr virus (EBV).

CMD-003 (baltaleucel-T) is an investigational therapy in which the patient's T cells are activated to kill malignant cells expressing EBV antigens. The product is being investigated in the international open label Phase 2 CITADEL clinical trial for patients with extranodal natural killer T cell lymphoma (ENKTCL), a type of non-Hodgkin lymphoma. Cell Medica has also opened the Phase 2 CIVIC clinical trial to explore the potential benefits of CMD-003 for patients with EBV-positive diffuse large cell lymphoma (DLBCL), Hodgkin lymphoma, and post-transplant lymphoproliferative disease (PTLD). 

Maina Bhaman, Director Healthcare Ventures at Touchstone Innovations, said:

“This is a very positive development for Cell Medica as the Fast Track designation for CMD-003 will facilitate the development of CMD-003 and makes the product eligible for accelerated approval and priority BLA review if relevant criteria are met.

“CMD-003 has the potential to treat a range of cancers associated with the EBV virus which infects more than 90% of the human population on a latent basis and is known to be associated with various types of cancer, including 15‐20% of lymphomas, 95% of nasopharyngeal carcinomas and 10% of gastric cancer.”

Cell Medica is a cellular immunotherapy company, focused on the development, manufacture and marketing of cell-based therapeutics for the treatment of cancer. As at 31 July 2016, the Group had a 25.5% interest in the issued share capital of the Company with such interest having a net fair value of £28.5 million.