ViroCell signs manufacturing services agreement with UCL to accelerate research into prevention of relapse in childhood blood cancer

Agreement will leverage ViroCell’s expertise in lentiviral vector manufacturing for an innovative CAR T-cell therapy for the treatment of paediatric acute lymphoblastic leukaemia

London, UK and New York, US, 12 December 2023 – ViroCell Biologics (“ViroCell” or the “Company”), a specialist viral vector Contract Development and Manufacturing Organisation (“CDMO”) for cell and gene therapy (CGT) clinical trials, announces a new partnership with University College London (“UCL”) to advance Professor Persis Amrolia’s innovative chimeric antigen receptor (CAR) T-cell therapy for relapsed paediatric acute lymphoblastic leukaemia (ALL). Dr. Amrolia is 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.

ALL is the most common cancer in childhood and, whilst 85% of patients can be cured with conventional chemotherapy and stem cell transplant, relapsed ALL remains one of the leading causes of cancer death in children. Genetically modified CAR T-cells targeting CD19 have shown impressive outcomes in relapsed/refractory ALL.

However, 50% of responding patients will relapse either due to evolution of CD19 negative disease or early loss of CAR T-cells so that only around 40% of patients are cured by the currently licensed CAR T-cell therapies. There is thus a clear unmet need to develop novel CAR T-cell products with improved efficacy. To address these challenges, Professor Amrolia has developed a cutting-edge solution that preserves early “stem cell memory” T-cells, which persist longer in patients together with dual targeting with both CD19 and CD22 CAR T-cells to prevent antigen-negative relapse.
Professor Amrolia selected ViroCell as a partner to manufacture the lentiviral vector for this novel CAR T-cell therapy. Through this collaboration, UCL’s world-leading research capabilities will be supported by ViroCell’s expertise in the manufacturing of high-specificity lentiviral vectors to advance UCL’s Phase I CARPALL cohort 4 clinical trial in children and young adults (age <18) with relapsed/refractory ALL. The study is expected to initiate in Q2 2024.

Farzin Farzaneh, PhD, CSO of ViroCell, commented: “We are honoured to be partnering with such a prestigious research institution as UCL to bring next generation CAR T-cells to paediatric patients with relapsed acute lymphoblastic leukaemia. We at ViroCell are passionately focused on leveraging our experience in viral vector design and supply to support bringing innovative therapies like Professor Amrolia’s to patients.”

Persis Amrolia, Professor of Transplantation Immunology, University College London, commented: “I am excited to be working with ViroCell to supply the lentiviral vector for our relapsed ALL programme. The depth of experience of the team, paired with their commitment to speed in manufacturing, testing and release makes ViroCell the ideal partner for innovators looking to transition their therapy swiftly from vector design to manufacturing and, ultimately, into patients.”

This agreement follows the recent UK Medicines and Healthcare products Regulatory Agency approval of ViroCell’s manufacturing operations at Great Ormond Street Hospital’s (GOSH) state-of-the-art manufacturing facility, the Zayed Centre for Research. The Manufacturer’s Authorisation License granted to GOSH, announced on 1 November 2023, allows ViroCell to manufacture and globally export its high-quality viral vectors for use in cell and gene therapy clinical trials.

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