Partners will develop commercial GMP process and hope to start Phase II/III study in 2012.
Cell Medica and the Center for Cell and Gene Therapy (CAGT) at Baylor College of Medicine signed a research collaboration and license agreement for development and commercialization of the latter’s clinical-stage cell-based treatment for cancers associated with oncogenic Epstein Barr virus (EBV). The partners will work together to establish a commercially viable GMP manufacturing process for the EBV cytotoxic lymphocyte (CTL) therapy, and project starting a Phase II/III trial by 2012. Cell Medica and CAGT first teamed up at the start of 2010 to work together on the commercialization of clinically proven cell therapies pioneered by Baylor.
The technology forming the basis of this latest deal involves the recovery of EBV CTLs from a patient and their activation via an ex vivo procedure prior to reinfusion back into the patient. CAGT has already used this approach to treat over 250 patients, and generated a body of evidence suggesting that EBV-CTLs can induce long-term cancer remission and prevent relapse, Cell Medica claims.
CAGT is currently evaluating the treatment in patients with EBV-associated Hodgkin lymphomas and non-Hodgkin lymphoma. It says results suggest that of 17 patients in remission but at high risk of relapse, treatment with EBV-CTL allowed 16 to remain in remission for a median of 2.5 years. Of the 16 EBV-CTL-treated patients with active disease that was refractory to standard therapy, 11 had clinical responses, including eight complete responses.
“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,” notes Malcolm Brenner, M.D., CAGT director. “Based on 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.”
“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,” adds Gregg Sando, Cell Medica CEO.
U.K.-based T-cell immunotherapy firm Cell Medica’s own lead product is designed to protect immunosuppressed patients at high risk of infection from cytomegalovirus (CMV) following allogeneic hematopoietic stem cell (bone marrow) transplant. The technique involves purifying CMV-specific T cells from the bone marrow donor’s blood, and giving these to the recipient patient. In September 2010 Cell Medica announced treatment of the first patient in the late-stage CMV-IMPACT clinical study, designed to demonstrate the clinical effectiveness of immunoprophylactic adoptive cellular therapy for the treatment of cytomegalovirus infections in immunosuppressed patients.
The trial, funded by the Wellcome Trust through a Translation Award will include 110 patients across 11 U.K.-based hospitals.