2013-09-26 08:05:03 -
Cell Medica, a leading T cell therapeutics company, today announced the opening of its European commercial manufacturing facility at the Max-Delbrück-Center of Molecular Medicine within the biotechnology park of Campus Berlin-Buch (Germany). This state-of-the-art facility for the GMP production of cell and gene therapies includes approximately 350 m2 clean room space.
Initial manufacturing will focus on Cytovir™ CMV – an innovative treatment which uses the immune cells of a healthy donor to restore viral immunity against Cytomegalovirus infections in patients who are immunocompromized following allogeneic hematopoietic stem cell (bone marrow) transplant. The commercial launch of this product is planned in early 2014 and will confirm Cell Medica’s position as one of the leaders in the development and market delivery of T
cell therapeutics – a new paradigm for the treatment of cancer and infections.
Dr. Rainer Knaus, Managing Director of Cell Medica GmbH and Head of the Company’s global manufacturing operations, commented: “This facility has been designed and equipped to provide high quality GMP compliant production of patient-specific cell and gene therapies for distribution across Europe. We are also very fortunate to have attracted highly educated and well-trained personnel who are keen to help shape this new era of cell-based therapeutics”, says Dr. Knaus. “These manufacturing specialists are preparing the facility for the supply of Cytovir CMV in early 2014.”
The facility in Berlin-Buch will also be important for Cell Medica’s planned CITADEL study for the investigation of Cell Medica’s T cell therapy for the treatment of EBV-associated lymphomas. The provision of investigational medicinal products for European study centers will be undertaken following the required regulatory approvals.
The financing of Cell Medica’s investment in the Berlin-Buch facility is supported in part by the Investitionsbank Berlin (IBB), the business development and promotional bank of the Federal Land of Berlin.
Notes to Editors
About Cell Medica
Cell Medica is a cellular therapeutics company engaged in the development, manufacturing and marketing of T cell immunotherapy approaches for the treatment of infections and cancers related to oncogenic viruses. The Company’s lead cell product, Cytovir™ CMV, for the treatment and prevention of cytomegalovirus (CMV) infections in patients following allogeneic bone marrow transplant, is available in the UK and is under development in other territories. Cytovir™ ADV is being developed for the treatment of adenovirus infections in pediatric patients following bone marrow transplantation. Cell Medica is also working with the Center for Cell and Gene Therapy, Baylor College of Medicine, to develop a cancer cellular therapeutic for the treatment of malignancies associated with the oncogenic Epstein Barr Virus.
About T cell immunotherapy
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 viral infections. Certain cancers are also associated with infection by viruses such as the Epstein-Barr Virus (EBV). Ongoing clinical research at UCL, Baylor College of Medicine and other institutions is exploring how T cell immunotherapy may be used to eliminate malignant cells which express viral antigens.
About Cytovir CMV
Cytovir™ CMV is available on clinician's request (UK only). It is comprised of naturally occurring CMV-specific cytotoxic T lymphocyte cells (T cells) that are directly selected from a seropositive donor.
Cytovir CMV is under development by Cell Medica as a novel treatment for cytomegalovirus infections in patients following allogeneic hematopoietic stem cell (bone marrow) transplantation by means of virus-specific immune reconstitution.
In Germany, the competent authority has confirmed that Cytovir CMV can be placed on the market under a manufacturing license.
About cancer cellular therapeutics in development
Cell Medica is developing a formulation of autologous cytotoxic T cell lymphocytes expanded to target EBV tumor-associated antigens. This product is under early phase clinical development as a specific cancer cellular therapeutic for a subset of EBV-associated advanced relapsed, refractory lymphoma.
Investitionsbank Berlin (IBB) is the business development and promotional bank of the Federal Land of Berlin. With a wide product spectrum it is active in the areas of business and property promotion.
IBB supports small and medium-sized enterprises in Berlin with subsidies, loan products and equity stakes developing targeted solutions for its clients. In doing so it works in close cooperation with all local commercial banks.
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For more information, please contact:Gregg Sando, CEO,Cell
Medica Limited+44 (0)20 7554 4070 www.cellmedica.co.uk : www.cellmedica.co.uk