18 Mar 2015 07:00
18 March 2015
Imperial Innovations Group plc
Cell Medica granted Orphan Drug designation for novel cellular therapy and treats first lymphoma patient in CITADEL Phase II trial
Imperial Innovations Group plc (AIM: IVO, "Innovations", "the Group") is pleased to note that its portfolio company Cell Medica ("the Company") has today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the Company's lead cancer immunotherapy product CMD-003. The designation was granted for the treatment of Epstein-Barr Virus (EBV) positive non-Hodgkin lymphomas. Additionally, the Company announced the treatment of the first patient in its CITADEL Phase II trial. This is a clinical study investigating the safety and efficacy of CMD-003 for the treatment of aggressive extranodal NK/T cell lymphoma (ENKTCL) in patients whose treatment with other therapies has proved unsuccessful. The patient was treated at Dana-Farber Cancer Center in Boston, Massachusetts.
CMD‐003, is a novel cellular therapy product that comprises T‐cells targeted at malignant cells that express the oncogenic Epstein Barr virus (EBV). EBV is a ubiquitous virus that 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. The expression of EBV antigens by tumor cells thus provides the opportunity to use the patient's own immune cells to target and kill the cancer.
CMD-003 is produced from the patient's own T cells which are harvested from a blood sample and sent to Cell Medica's manufacturing site for activation and expansion through a proprietary procedure that has been developed for commercial-scale use.
The CITADEL Trial will investigate whether CMD-003 is safe and effective as a potential therapy for patients who have failed conventional treatment of advanced extranodal NK/T cell lymphoma. The trial will include NK/T cell lymphoma patients recruited at 24 centres in five countries as part of clinical development programme aimed at regulatory approval in the USA, Europe and Korea.
Maina Bhaman, Director of Healthcare Investments at Innovations, said:
"Cytotoxic T cells are an exciting therapeutic area in oncology and we are hopeful that this approach will offer an effective new treatment option for these patients for which there are few other treatment options available.
"The Grant of Orphan Drug status by the FDA for CMD-003 together with the start of the CITADEL trial are further indications of strong progress. Cell Medica is one of our five largest unquoted investments and having completed a recent £50m Series B funding round, the Company is well positioned as a leader in cellular immunotherapy."
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Notes to editors
About Imperial Innovations - www.imperialinnovations.co.uk
Imperial Innovations Group plc creates, builds and invests in pioneering technologies developed from the academic research within the 'Golden Triangle' broadly bounded by London, Cambridge and Oxford, which is home to the UK's four leading research-intensive universities.
This area is home to many new technology companies through its proximity to the academic communities of Imperial College London, the University of Cambridge, the University of Oxford and University College London, as well as other leading research institutions.
Imperial College London, the University of Cambridge, the University of Oxford and University College London collectively have research income of £1.4 billion per annum and are ranked as four of the top ten Universities in the world (source: QS World University Rankings 2014/15).
Innovations supports scientists and entrepreneurs in the commercialisation of their ideas through the licensing of intellectual property, by leading the formation of new companies, providing facilities in the early stages, providing investment and encouraging co-investment to accelerate development, providing operational expertise and recruiting high-calibre management teams. It also runs an incubator in London that is the initial home for many of its technology spin-outs.
Since admission of its shares to trading on AIM in 2006, Innovations has raised more than £346.0 million of equity from investors, which has enabled it to invest in some of the most exciting spin-outs to come out of UK academic research. In addition, the Group has a £30.0 million loan facility from the European Investment Bank (EIB) for investment in biotech and therapeutics businesses.
During the period from admission on AIM up until 31 July 2014, Innovations has invested a total of £176.0 million across its portfolio companies, which have raised collectively investment of £822.5 million.
About Cell Medica - www.cellmedica.co.uk
Cell Medica is a cellular therapeutics company engaged in the development, manufacturing and marketing of cellular immunotherapy products for infectious disease and cancer. The Company's Cytovir™ product family for immune reconstitution is for the treatment of infections caused by latent viruses in immunosuppressed patients following allogeneic haematopoietic stem cell (bone marrow) transplant. In the field of cancer immunotherapy, Cell Medica is targeting a range of cancers associated with the oncogenic Epstein Barr Virus (EBV) including lymphoma and nasopharyngeal carcinoma.
About extranodal NKT cell lymphoma
Extranodal NK/T-cell lymphoma (ENKTCL) is a rare type of non-Hodgkin lymphoma (NHL) recognized as a separate entity by the World Health Organization. ENKTCL is almost always positive for Epstein-Barr virus (EBV). The incidence in the US is approximately 650 cases per annum with an estimated prevalence of 4,500 patients but higher in Asia where it represents 6% - 9% of NHL. It is an aggressive lymphoma with median survivals of 13-42 months and 5-year overall survivals (OS) of 20% to 65%.
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 can be used as a cellular therapeutic 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 Orphan Drug Designation
Orphan Drug designation is granted by the FDA's Office of Orphan Products Development for drugs that target conditions affecting 200,000 or fewer U.S. patients annually. Orphan Drug designation qualifies a company for several benefits across all stages of drug development, which include accessibility to grants, seven years of market exclusivity following marketing approval, and tax credits on U.S. clinical trials.