Cell Medica, a leading 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). Financial terms were not disclosed.
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.
EBV is present in 90% of the human population and the virus resides in a latent state in B cells and epithelial cells in the nasopharynx. EBV was one of the first viruses to be associated with malignancies. The expression of EBV antigens by cancerous cells provides the opportunity to use EBV antigen-specific cytotoxic T lymphocytes (EBV CTLs) for therapy. EBV CTLs can be recovered from the patient and activated through an ex vivo procedure to enhance their ability to target and kill tumour cells. Re-infusion of these activated T cells into the patient has been shown to be safe and effective as a curative treatment for EBV associated malignancies.
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 trial1 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 ongoing2.
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.
Professor Malcolm Brenner, Director of the Center for Cell and Gene Therapy, said: “The results from our ongoing lymphoma clinical trial demonstrate that cellular immunotherapy can be used very effectively to target cancerous cells which co-express viral antigens. Based upon our recent success with an improved product design, we are looking forward to working with Cell Medica to take this therapy into advanced clinical trials and regulatory approval.”
Gregg Sando, CEO of Cell Medica, commented: “We are very excited to be signing this exclusive license agreement and further strengthening our relationship with the CAGT who we believe is the clear leader in the use of research and development of cell therapies targeting EBV-related disease. Clinical results arising from the current trials indicate that this cell product is an excellent candidate for commercialization. Different types of cancer can be targeted in different ways, and EBV CTLs provide an effective approach to treat EBV associated malignancies. We will use our experience in the manufacturing scale-up, regulatory approval and reimbursement of cell therapies to bring this cell therapy into routine clinical practice as rapidly as possible.”
1 Bollard CM et al. Complete responses of relapsed lymphoma following genetic modification of tumor-antigen presenting cells and T-lymphocyte transfer. Blood; 110:2838–2845 (2007).
2 Louis CU et al. Adoptive Transfer of EBV-specific T Cells Results in Sustained Clinical Responses in Patients With Locoregional Nasopharyngeal Carcinoma. Journal of Immunotherapy; 33:983–990 (2010).