ViroCell Signs Manufacturing Services Agreement with UCL to ...

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 & NEW YORK, December 12, 2023--(BUSINESS WIRE)--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.

Notes to editor:

ViroCell
www.virocell.com

ViroCell Biologics is an innovation-driven Contract Development and Manufacturing Organisation ("CDMO") focused exclusively on the design and GMP manufacture of viral vectors for clinical trials. Built around one of the most prolific academic viral vector manufacturing teams, ViroCell was created to address the global demand for precisely engineered viral vectors and aims to become the partner of choice for companies developing cell and gene therapies. The team leverages its deep track record to help clients to de-risk and accelerate novel cell and gene therapies into and through clinical development, with a mission of being the partner of choice for corporate and academic innovators in this field. Focused initially on manufacturing lentivirus and gamma-retrovirus vectors, ViroCell enables clients to start clinical trials on a scalable platform, delivering value by reducing costs, time and regulatory risk.

University College London
www.ucl.ac.uk

University College London (UCL) is a world-leading public research university. The Faculty of Life Sciences is home to one of the most successful and productive groupings of biomedical researchers within Europe. The Faculty is internationally recognised for its curiosity led and translational research in many life-science disciplines including neurosciences, genetics, structural, molecular, cellular, developmental, computational and environmental biology, biodiversity, and drug discovery. The Comprehensive Clinical Trials Unit (CCTU) at UCL collaborates with researchers to design, conduct, analyse and publish clinical trials and other well-designed studies. The unit provides clinical, statistical and trial operations leadership and facilitates the delivery of high quality, regulatory compliant clinical trials of both investigational medicinal products.

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