Last checked at 17 Jan 2018 07:00
Oxford BioMedica notes the US FDA Priority Review for Kymriah™ for adults with r/r DLBCL and EMA accelerated assessment for children, young adults with r/r B-cell ALL and adult patients with r/r DLBCL
Oxford, UK - 17 January 2018: Oxford BioMedica plc ("Oxford BioMedica" or "the Group") (LSE:OXB), a leading gene and cell therapy group, today notes an announcement by Novartis that the supplemental Biologics License Application (sBLA) for Kymriah™ (tisagenlecleucel, formerly CTL019) suspension for intravenous infusion for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who are ineligible for or relapse after autologous stem cell transplant (ASCT), has been accepted by the US Food and Drug Administration (FDA) for Priority Review. In addition, the European Medicines Agency (EMA) has granted accelerated assessment to the Marketing Authorisation Application (MAA) for Kymriah for the treatment of children and young adults with r/r B-cell acute lymphoblastic leukaemia (ALL) and for adult patients with r/r DLBCL who are ineligible for ASCT. CTL019 is a novel immunocellular therapy and a one-time treatment that uses a patient's own T cells to fight cancer.
Priority Review and accelerated assessment are granted to therapies which may provide a significant improvement in the safety and effectiveness of the treatment of a serious disease, and the designations are intended to expedite the standard review time. If approved by the FDA and EMA, Kymriah would represent the first chimeric antigen receptor T cell (CAR-T) therapy available for two distinct indications in non-Hodgkin lymphoma and B-cell ALL.
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 -
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 300 people. Further information is available at www.oxfordbiomedica.co.uk.