Oxford, UK – 17 January 2018: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:Oxford Biomedica), a leading gene and cell therapy group, today notes an announcement by Novartis that the supplemental Biologics License Application (sBLA) for Kymriah™ (tisagenlecleucel, formerly CTL019) suspension for intravenous infusion for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who are ineligible for or relapse after autologous stem cell transplant (ASCT), has been accepted by the US Food and Drug Administration (FDA) for Priority Review. In addition, the European Medicines Agency (EMA) has granted accelerated assessment to the Marketing Authorisation Application (MAA) for Kymriah for the treatment of children and young adults with r/r B-cell acute lymphoblastic leukaemia (ALL) and for adult patients with r/r DLBCL who are ineligible for ASCT. CTL019 is a novel immunocellular therapy and a one-time treatment that uses a patient’s own T cells to fight cancer.
Priority Review and accelerated assessment are granted to therapies which may provide a significant improvement in the safety and effectiveness of the treatment of a serious disease, and the designations are intended to expedite the standard review time. If approved by the FDA and EMA, Kymriah would represent the first chimeric antigen receptor T cell (CAR-T) therapy available for two distinct indications in non-Hodgkin lymphoma and B-cell ALL.
Oxford BioMedica is the sole manufacturer of the lentiviral vector that encodes CTL019. The Group signed an agreement with Novartis in July 2017 for the commercial and clinical supply of lentiviral vectors used to generate CTL019 and other undisclosed CAR-T products, for which Oxford BioMedica could potentially receive in excess of $100m from Novartis over the next three years. As announced in October 2014, Oxford BioMedica will also receive undisclosed royalties on potential future sales of Novartis CAR-T products.
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