Cell Medica, a leading cellular immunotherapy company, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company's cancer immunotherapy treatment, referred to as CMD-003, under development for Epstein-Barr Virus (EBV) positive non-Hodgkin lymphomas. Additionally, the company announced the treatment of the first patient in the CITADEL Phase II clinical trial investigating the safety and efficacy of CMD-003 for the treatment of aggressive extranodal NK/T cell lymphoma (ENKTCL) in patients who have failed previous therapies. The patient was treated at the Dana-Farber Cancer Institute in Boston, MA under the care of Dr Eric Jacobsen.
Dr Jacobsen, clinical director of the adult lymphoma program at Dana-Farber Cancer Institute and an assistant professor of medicine at Harvard Medical School, said: "Extranodal NK/T cell lymphoma can be a difficult disease to treat. Until recently there has been limited research devoted to this relatively rare disease. We are very excited to have treated the first patient in the CITADEL trial. Cytotoxic T cells are an exciting therapeutic area in oncology and I am hopeful that this approach will offer an effective new treatment option for these patients."
CMD-003 is a novel way to target a range of cancers associated with the oncogenic Epstein-Barr Virus (EBV). The treatment has been developed by Cell Medica in collaboration with the Center for Cell and Gene Therapy (CAGT) at Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital. CMD-003 is produced from patient immune cells taken from a blood sample and sent to the Company's manufacturing site for activation and expansion through a proprietary procedure developed for commercial-scale use. CAGT (Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital) has treated more than 250 patients with research prototypes of CMD-003 and has reported promising clinical results across a range of malignancies.
The CITADEL Trial will include NK/T cell lymphoma patients who have failed conventional treatment of advanced extranodal NK/T cell lymphoma. The trial will include patients recruited at 24 centers in five countries as part of clinical development programme aimed at regulatory approval in the USA, Europe and South Korea.
Chief investigator Dr Helen Heslop, Interim Director of CAGT at Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, said: "It is very gratifying to see an innovative cell therapy approach, developed here by Dr Cliona Rooney and other CAGT investigators, progressing towards regulatory approval and clinical adoption."
Gregg Sando, CEO of Cell Medica, commented: "The CITADEL trial will investigate a new approach for treating patients with EBV-associated NK/T cell lymphoma by harnessing the human immune system to target and kill the cancer. With the Orphan Drug Designation, we can look forward to FDA regulatory support and incentives for the development of this novel therapy. These are important steps which show we are making real progress with cellular immunotherapy as a powerful new technology with the potential to transform the treatment of cancer patients."
The development of CMD-003 and the CITADEL Trial are funded in part by an investment from the Cancer Prevention and Research Institute of Texas (CPRIT) alongside Cell Medica's other strategic investors including Imperial Innovations, Invesco, Woodford Investment Management and The Wellcome Trust.