Kymriah® receives European Commission Approval

RNS Number : 9358Y

Oxford Biomedica PLC

28 August 2018

 

Kymriah^® (tisagenlecleucel, formerly CTL019) receives European Commission Approval

London, UK - 28 August 2018: Oxford BioMedica plc ("Oxford BioMedica" or "the Group") (LSE:OXB), a leading gene and cell therapy group, today notes that the European Commission (EC) has approved the Novartis CAR-T cell therapy, Kymriah^® (tisagenlecleucel, formerly CTL019). The approved indications are for the treatment of paediatric and young adults up to 25 years of age with B-cell acute lymphoblastic leukaemia that is refractory, in relapse post-transplant or in second stage or later relapse; and for the treatment of adults with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Kymriah, developed by Novartis in collaboration with the University of Pennsylvania (Penn), is a ground breaking one time treatment that uses a patient's own T cells to fight cancer, and the only chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval in the EU for these two distinct B-cell malignancies. Kymriah was also the first CAR-T cell therapy ever approved by the US Food and Drug Administration (FDA).

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.

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For further information, please contact:
Oxford BioMedica plc: John Dawson,  Chief Executive Officer Stuart Paynter, Chief Financial Officer	Tel: [phone]
Consilium Strategic Communications Mary-Jane Elliott/Matthew Neal/ Olivia Manser/Laura Thornton	Tel: [phone]

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, Boehringer Ingelheim/UK Cystic Fibrosis Gene Therapy Consortium/Imperial Innovations, 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)

Kymriah was first developed by the University of Pennsylvania (Penn) and uses the 4-1BB costimulatory domain in its chimeric antigen receptor to enhance cellular responses as well as persistence of Kymriah after it is infused into the patient, which may be associated with long-lasting remissions in patients.

The EC approval of Kymriah 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).

 

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