Date: 2011-01-06
Type of information: R&D agreement
Compound: cell-based treatment for cancers associated with the oncogenic Epstein Barr virus (EBV)
Company: Cell Medica (UK) Center for Cell and Gene Therapy (CAGT), Baylor College of Medicine (Houston, Texas - USA)
Therapeutic area: Cancer - Oncology
Type agreement: R&D
licensing
commercialisation
Action mechanism: cell therapy
Disease: EBV-associated lymphoma and nasopharyngeal carcinoma (NPC)
Details: Cell Medica, a cellular therapeutics company which develops, manufactures and markets cellular immunotherapy products for the treatment of infectious disease and cancer, has announced an exclusive license agreement and research collaboration with the Center for Cell and Gene Therapy (CAGT), Baylor College of Medicine (Houston, Texas), for the commercialization of an innovative cell-based treatment for cancers associated with the oncogenic Epstein Barr virus (EBV). Cell Medica’s expertise and experience in the development and manufacturing of cellular immunotherapy products in combination with the CAGT’s leading position in the research and development of cell therapies targeting EBV-related disease will accelerate the development of this potentially curative treatment for EBV-associated lymphoma and nasopharyngeal carcinoma (NPC). Cell Medica has already introduced its first cell therapy product in the UK which is based on antigen-specific T cells and is pioneering the manufacturing strategy for high volume production of patient-specific cell therapies. The CAGT has treated more than 250 patients over the past 15 years and has collected an impressive body of clinical data which indicate that EBV-CTLs can induce long-term cancer remission and prevent cancer relapse. An improved product design is currently being tested in an ongoing clinical trial 1 involving the treatment of EBV-associated Hodgkin lymphomas and non-Hodgkin lymphoma. A total of 33 evaluable patients in two treatment groups have received the cell therapy to date and no immediate toxicity was observed following infusion. Of 17 patients in remission but at high risk of relapse at the time of treatment, 16 remain in remission for a median of 2.5 years (ranging six months to more than five years). Of 16 patients with active disease refractory to standard treatment, 11 had clinical responses, including 8 complete responses, with a median duration of the clinical responses at 1.5 years. In the NPC application, the CAGT recently reported indications of positive clinical results in patients with locoregional disease and further investigation is ongoing. Based on the positive clinical results Cell Medica and CAGT will collaborate to establish a commercially viable and fully GMP compliant manufacturing process as part of a plan to launch a confirmatory multicenter Phase II/III trial by 2012. Cell Medica believes the potential market size for successful treatment of EBV associated Hodgkin lymphoma, non-Hodgkin lymphoma and nasopharyngeal carcinoma could exceed $1.0 billion based on the application of the cellular therapy in first or second line treatment for these diseases.
Financial terms: Financial terms were not disclosed.
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