Cell Medica signs agreement with Texan gene therapy centre

Focuses on innovative cellular treatments for EBV associated cancers

Cell Medica, a London, UK-based developer of cellular immunotherapy products for the treatment of infectious disease and cancer, has signed an exclusive licence agreement and research collaboration with the Center for Cell and Gene Therapy (CAGT), Baylor College of Medicine in Houston, Texas, US, to accelerate the launch of a cell-based treatment for cancers associated with the Epstein Barr virus (EBV).

Financial terms were not disclosed, but Cell Medica estimates that the market potential for the treatment of EBV associated Hodgkin lymphona, non-Hodgkin lymphona and nasopharyngeal carcinoma will exceed US$1bn.

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.

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. Reinfusion 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 clinical data indicating 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 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.

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 multicentre Phase II/III trial by 2012.

Professor Malcolm Brenner, director of CAGT, said: ‘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, added: ‘Clinical results arising from the current trials indicate that this cell product is an excellent candidate for commercialisation. Different types of cancer can be targeted in different ways, and EBV CTLs provide an effective approach to treat EBV associated malignancies.’

Cell Medica is a partnership of clinicians, scientists, universities, and investors working together to make T cell immunotherapy available to patients on a routine basis rather than being confined to a few research hospitals in a clinical trial setting.

The firm’s research partners include the Royal Free Hospital, University College London, Imperial College London, and the University of Würzburg, Germany.

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