Oxford Biomedica PLC

Regulatory Filings • May 2, 2018

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RNS Number : 8213M

Oxford Biomedica PLC

02 May 2018

Kymriah receives FDA approval to treat appropriate patients with large B-cell lymphoma 

London, UK - 02 May 2018: Oxford BioMedica plc ("Oxford BioMedica" or "the Group") (LSE:OXB), a leading gene and cell therapy group, today notes that the US Food and Drug Administration (FDA) has approved Novartis' chimeric antigen receptor T cell (CAR-T) therapy Kymriah® (tisagenlecleucel, formerly CTL019) suspension for intravenous infusion for its second indication - the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Kymriah is not indicated for the treatment of patients with primary central nervous system lymphoma. Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient's own T cells to fight cancer.

Kymriah is the first CAR-T therapy available in the US for two distinct indications in non-Hodgkin lymphoma (NHL) and B-cell acute lymphoblastic leukaemia (ALL). DLBCL is the most common form of NHL.

Oxford BioMedica is the sole manufacturer of the lentiviral vector that encodes 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.

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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 Mary-Jane Elliott/Matthew Neal/Philippa Gardner/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, GSK, 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 FDA approval is based on the Novartis-led pivotal phase II JULIET clinical trial (NCT02445248).

This information is provided by RNS

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