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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.
About Touchstone Innovations – www.touchstoneinnovations.com
Touchstone Innovations plc (formerly Imperial Innovations Group plc or just “Innovations”) creates, builds and invests in pioneering technology companies and licensing opportunities developed from outstanding scientific research from the 'Golden Triangle', the geographical region broadly bounded by London, Cambridge and Oxford.
This area has an unrivalled cluster of outstanding academic research and technology businesses, and is home to four of the world’s top 10 universities, as well as leading research institutions, the cream of the UK’s science and technology businesses and many of its leading investors.
Innovations supports scientists and entrepreneurs in the commercialisation of their ideas through protecting and licensing out intellectual property (through its Technology Transfer subsidiary, Imperial Innovations), by leading the formation of new companies, by recruiting high calibre management teams and by providing investment and encouraging co-investment. Innovations remains an active investor over the life of its portfolio companies, with the majority of Innovations’ investment going into businesses in which it is already a shareholder.
Since becoming a public company in 2006, Innovations has raised more than £440 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 agreed £80.0 million in loan facilities from the European Investment Bank (EIB).
Between Innovations’ admission to AIM (August 2006) and 31 July 2016, Innovations has invested a total of £306.7 million across its portfolio companies, which have collectively raised investment of £1.5 billion.
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...