Start of commercial cell therapy manufacturing at the Max-Delbrück-Center of Molecular Medicine in Berlin-Buch (Germany).
London, UK – 19 February 2015 : Cell Medica, a leading cellular immunotherapy company, today announced the start of commercial cell therapy manufacturing at its facility at the Max-Delbrück-Center of Molecular Medicine in Berlin-Buch (Germany). The first product has been successfully manufactured and delivered for use in the patient.
Manufacturing at this site will initially be focused on Cytovir™ CMV for the treatment of patients with cytomegalovirus (CMV) infections following a hematopoietic stem cell (bone marrow) transplant. Cytovir™ CMV is comprised of naturally-occurring donor cytotoxic T cells which are transferred to the patient to restore viral immunity against CMV. The cell therapy is individually manufactured for each patient. The commercial delivery of this product confirms Cell Medica’s leading position in transforming the treatment of cancer and infections through innovative cellular immunotherapy techniques.
The production of Cytovir™ CMV has been engineered based on a closed system which contains the cell product within aseptic conditions throughout the manufacturing process. The closed system is critical to enable high-volume, cost efficient production. Cell Medica acquired this GMP production facility in 2013 and received a commercial manufacturing license using the new manufacturing system in November 2014.
Gregg Sando, CEO of Cell Medica Ltd. commented: “This facility has been designed and equipped to provide high quality GMP-compliant production of patient-specific cell therapies for distribution across Europe. We are very excited to have taken our lead product from early development into commercial sales with an industrial-scale manufacturing system. We are among the very first companies in the world to have demonstrated this capability.”
Cell Medica is a leading cellular immunotherapy company, focused on the development, manufacturing and marketing of cell-based therapeutics for the treatment of cancers related to oncogenic viruses and infections following hematopoietic stem cell transplantations. In addition to Cytovir™ CMV, the Company is also developing Cytovir™ ADV for the treatment of adenovirus infections in pediatric patients following hematopoietic stem cell (bone marrow) transplantations. Cell Medica is also working with the Center for Cell and Gene Therapy, Baylor College of Medicine, to develop cellular therapeutics for the treatment of malignancies associated with the oncogenic Epstein Barr Virus.
Cytovir™ CMV is comprised of naturally occurring CMV-specific cytotoxic T lymphocyte cells (T cells) that are directly selected from a seropositive donor. The safety and efficacy of Cytovir CMV has been investigated in two randomized clinical trials, ASPECT (NCT01220895) and IMPACT (NCT01077908). Cytovir™ CMV is commercially available in the UK, Ireland and Germany.
T cell immunotherapy involves harnessing the power and precision of the human immune system to treat disease. Extensive academic research in the field of clinical immunology has provided early evidence that T cells may be used for the treatment of cancers. Many new drugs under development by pharmaceutical companies are targeting strategies to enhance the natural immune response to fighting cancer.
19th February 2015