Press releases

Oxford BioMedica notes the CTL019 MAA submission to the EMA for children, young adults with r/r B-cell ALL and adult patients with r/r DLBCL

Oxford, UK – 06 November 2017: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today notes an announcement by Novartis confirming submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for CTL019 (tisagenlecleucel) for two indications. The application is for the treatment of children and young adults with relapsed or refractory (r/r) B-cell acute lymphoblastic leukaemia (ALL) and for adult patients with r/r diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT). CTL019 is a novel immunocellular therapy and a one-time treatment that uses a patient’s own T cells to fight cancer.

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.

- Ends -

Notes to editors

About Oxford BioMedica®

Oxford BioMedica (LSE:OXB) is a leading gene and cell therapy company 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®) through which the Group develops 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, Sanofi, GSK, 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 250 people. Further information is available at www.oxfordbiomedica.co.uk.

For further information please contact

Oxford BioMedica plc

John Dawson, Chief Executive Officer

Stuart Paynter, Chief Financial Officer

Tel: +44 (0)1865 783 000

 

Consilium Strategic Communications – Media Enquiries

Mary-Jane Elliott/Matthew Neal/Philippa Gardner/Laura Thornton/Rosie Phillips

Tel: +44 (0)20 3709 5700

 

Jefferies (Corporate Broker) 

Gil Bar-Nahum/Simon Hardy/Lee Morton/Max Jones/Nicholas Moore

Tel: +44 (0)20 7029 8000