Cell Medica Signs an Exclusive License Agreement and Strengthens Collaboration With the Center for Cell and Gene Therapy, Baylor College of Medicine

January 6, 2011
    LONDON, January 6, 2011 /PRNewswire/ --
    - Agreement Focuses on Innovative Cellular Treatments for EBV Associated
    - Positive Results Already Seen in Current Clinical Development
    - Significant Market Potential, Estimated to Exceed $1.0 billion

Cell Medica, a leading cellular therapeutics company which develops,
manufactures and markets cellular immunotherapy products for the treatment of
infectious disease and cancer, is pleased to announce 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 tumor 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
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.[2]

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).

Notes to Editors

About the Center for Cell and Gene Therapy

The Center for Cell and Gene Therapy, based in Houston, Texas, was
established by Baylor College of Medicine, The Methodist Hospital and Texas
Children’s Hospital to provide a research infrastructure to rapidly translate
novel cell and gene therapy protocols from the laboratory to the clinic.

About Cell Medica

Cell Medica is a cellular therapeutics company engaged in developing,
manufacturing and marketing of cellular immunotherapy treatment strategies
for infectious disease and cancer. The Company’s lead clinical application,
Cytovir CMV, is for the treatment of cytomegalovirus infections in patients
following allogeneic haematopoietic stem cell (bone marrow) transplant. The
Company is currently sponsoring a confirmatory (Phase III style) clinical
trial for Cytovir CMV across 15 bone marrow transplant centers in the UK. The
development of cancer immunotherapy applications represents a natural
progression of the Company’s core expertise in using antigen-specific T cells
immunotherapy to treat disease. In addition to the License and Collaboration
Agreement with the Center for Cell and Gene Therapy, Cell Medica has also
licensed a T cell gene therapy technology for the treatment of leukaemia.

    For further information visit http://www.cellmedica.co.uk or contact:

    Cell Medica

    Gregg Sando, CEO
    Cell Medica Limited


    Mary-Jane Elliott/ Nick Francis/ Amber Bielecka

SOURCE Cell Medica

Source: newswire

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