ViroCell Biologics, a specialized Contract Development and Manufacturing Organization (CDMO) focused on viral vectors for cell and gene therapy clinical trials, has announced a strategic collaboration with University College London (UCL) to advance the innovative chimeric antigen receptor (CAR) T-cell therapy for relapsed pediatric acute lymphoblastic leukemia (ALL) developed by Professor Persis Amrolia. Dr. Amrolia, an international leader in CAR T-cell therapy for pediatric ALL, holds the position of Professor of Transplantation Immunology at the UCL Great Ormond Street Institute of Child Health.
While conventional chemotherapy and stem cell transplant cure 85% of pediatric ALL cases, relapsed ALL remains a major cause of cancer-related deaths in children. Although genetically modified CAR T-cells targeting CD19 have shown promise in treating relapsed/refractory ALL, approximately 50% of responding patients experience relapse. This is often due to the evolution of CD19-negative disease or early loss of CAR T-cells, resulting in only around 40% of patients being cured by currently licensed CAR T-cell therapies. To address this challenge, Professor Amrolia has developed an advanced solution that preserves early "stem cell memory" T-cells, which persist longer in patients. This approach involves dual targeting with both CD19 and CD22 CAR T-cells to prevent antigen-negative relapse.
ViroCell has been selected as the manufacturing partner for the lentiviral vector required for this novel CAR T-cell therapy. The collaboration will leverage UCL's world-leading research capabilities and ViroCell's expertise in manufacturing high-specificity lentiviral vectors to advance UCL's Phase I CARPALL cohort 4 clinical trial, focusing on children and young adults (age <18) with relapsed/refractory ALL. The trial is anticipated to commence in Q2 2024.
This partnership comes on the heels of the recent approval by the UK Medicines and Healthcare products Regulatory Agency of ViroCell's manufacturing operations at the Zayed Centre for Research, a state-of-the-art facility located at Great Ormond Street Hospital (GOSH). The Manufacturer's Authorization License granted to GOSH on November 1, 2023, enables ViroCell to manufacture and globally export high-quality viral vectors for use in cell and gene therapy clinical trials.
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