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Oxford BioMedica notes the sBLA submission to FDA for Kymriah(TM) in adult patients with r/r DLBCL

Oxford BioMedica plc
Posted on: 31 Oct 17

Oxford BioMedica notes the sBLA submission to FDA for Kymriah(TM) in adult patients with r/r DLBCL

Oxford, UK - 31 October 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 supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for Kymriah TM (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT). Kymriah TM is a novel immunocellular therapy and a one-time treatment that uses a patient's own T cells to fight cancer.

The submission is based on results from the Novartis-sponsored, global, multi-centre Phase II JULIET study (NCT02445248), the first global, multi-centre registration study for Kymriah TM in adult patients with r/r DLBCL. In April 2017, Novartis received Breakthrough Therapy designation for r/r DLBCL which, if approved, would be the second indication for Kymriah TM .

Novartis plans to submit an additional application for marketing authorization for Kymriah TM with the European Medicines Agency (EMA) in both DLBCL and paediatric ALL later this year. Novartis plans additional regulatory filings for Kymriah TM outside the US and EU in 2018.

In August 2017, Kymriah TM became the first available chimeric antigen receptor T cell (CAR-T) therapy when it received FDA approval five weeks prior to its PDUFA date and was launched for patients up to 25 years of age with B-cell precursor acute lymphoblastic leukaemia (ALL) that is refractory or has relapsed at least twice.

Oxford BioMedica is the sole manufacturer of the lentiviral vector that encodes Kymriah TM . The Group signed an agreement with Novartis in July 2017 for the commercial and clinical supply of lentiviral vectors used to generate Kymriah TM 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 -


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/Rosie Phillips

 
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, Sanofi, GSK, Orchard Therapeutics 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 280 people. Further information is available at www.oxfordbiomedica.co.uk .



This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Oxford BioMedica plc via GlobeNewswire
HUG#2146192
GlobeNewswire
globenewswire.com

Last updated on: 01/11/2017

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