London, UK – 29 June 2018: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today notes that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of Novartis’ Kymriah® (tisagenlecleucel, formerly CTL019) – a novel one-time treatment that uses a patient’s own T cells to fight cancer. The positive opinion includes two B-cell malignancies: B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse in patients up to 25 years of age; and diffuse large B-cell lymphoma (DLBCL) that is relapsed or refractory (r/r) after two or more lines of systemic therapy in adults.
If approved by the European Commission, Kymriah will be the first CAR-T cell therapy available in the European Union (EU) for both DLBCL and B-cell ALL
Oxford BioMedica is the sole manufacturer of the lentiviral vector that encodes the CD19-directed chimeric antigen receptor in Kymriah. The Group signed an agreement with Novartis in July 2017 for the commercial and clinical supply of lentiviral vectors used to generate Kymriah 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.
For further information, please contact:
Oxford BioMedica plc:
John Dawson, Chief Executive Officer
Stuart Paynter, Chief Financial Officer
Tel: +44 (0)1865 783 000
Financial and corporate communications enquiries:
Consilium Strategic Communications
Mary-Jane Elliott/Matthew Neal/Laura Thornton
Tel: +44 (0)20 3709 5700
Notes for editors
About Oxford BioMedica
Oxford BioMedica (LSE:OXB) is a leading gene and cell therapy group focused on developing life changing treatments for serious diseases. Oxford BioMedica and its subsidiaries (the “Group”) have built a sector leading lentiviral vector delivery platform (LentiVector®), which the Group leverages to develop in vivo and ex vivo products both in-house and with partners. The Group has created a valuable proprietary portfolio of gene and cell therapy product candidates in the areas of oncology, ophthalmology and CNS disorders. The Group has also entered into a number of partnerships, including with Novartis, Bioverativ, Sanofi, Axovant, Orchard Therapeutics, GC LabCell and Immune Design, through which it has long-term economic interests in other potential gene and cell therapy products. Oxford BioMedica is based across several locations in Oxfordshire, UK and employs more than 320 people. Further information is available at www.oxfordbiomedica.co.uk.
About Kymriah® (tisagenlecleucel, formerly CTL019)
CTL019 was first developed by the University of Pennsylvania (Penn) and uses the 4-1BB costimulatory domain in its chimaeric antigen receptor to enhance cellular responses as well as persistence of CTL019 after it is infused into the patient, which may be associated with long-lasting remissions in patients. In 2012, Novartis and Penn entered into a global collaboration to further research, develop and commercialise CAR-T cell therapies, including Kymriah, for the investigational treatment of cancers.
The positive CHMP opinion is based on two pivotal Novartis-sponsored global, multi-centre, Phase II trials, ELIANA and JULIET, led by the University of Pennsylvania, which included patients from Europe among other regions in the world.
The collaboration of Novartis and the University of Pennsylvania has led to historic milestones in CAR-T cell therapy since 2012, including the initiation of the first global CAR-T trials, the PRIME designation granted by the EMA for Kymriah in paediatric patients with r/r B-cell ALL, and the approval of Kymriah in two distinct indications by the US Food and Drug Administration (FDA).