University College London (UCL) has selected ViroCell Biologics to manufacture the lentiviral vector for its CAR T-cell therapy for relapsed paediatric acute lymphoblastic leukemia (ALL).
ViroCell, a UK-based contract development manufacturing organization (CDMO) for cell and gene (CGT) clinical trials, will “manufacture a third generation, self-inactivating lentiviral vector for this project, using an adherent cell-based process,” a spokesperson for the firm told us.
“The lentiviral vector is a critical raw material in the CAR-T manufacturing process to genetically modify the T-cells.”
ALL is the most common type of cancer seen in children and despite 85% of patients being cured with chemotherapy and a stem cell transplant, relapsed ALL is one of the leading causes of cancer death in childhood.
According to both parties, there is an “unmet” need to advance CAR-T cell products with improved efficacy for these types of illnesses. To address said challenges, Persis Amrolia — professor of Transplantation Immunology at the UCL Great Ormond Street Institute of Child Health and an international leader in CAR T-cell therapy for paediatric ALL — has developed a solution that conserves early stem cell memory T-cells. In turn, this preserves longer in patients by targeting CD19 and CD22 CAR-T cells to hinder antigen-negative relapse.
The lentiviral vector produced by ViroCell will be used in the CAR-T manufacturing process for the Phase I CARPALL cohort 4 clinical trial.
In September 2021, ViroCell partnered with Great Ormond Street Hospital (GOSH) to address the global viral vector manufacturing bottleneck for clinical trials. At the time, the CDMO said the collaboration will more than double the UK’s lentivirus vector production capacity for clinical trials in 2022.
Furthermore, in November the Medicines and Healthcare products Regulatory Agency (MHRA) granted ViroCell manufacturing approval to produce viral vectors at GOSH for CGT clinical trials.
You May Also Like
