Oxford Biomedica PLC Kymriah receives Priority Review for adult DLBCL (0627C)
January 17 2018 - 2:00AM
UK Regulatory
TIDMOXB
RNS Number : 0627C
Oxford Biomedica PLC
17 January 2018
Oxford BioMedica notes the US FDA Priority Review for
Kymriah(TM) 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(TM)
(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: Tel: +44 (0)1865
John Dawson, Chief Executive Officer 783 000
Stuart Paynter, Chief Financial
Officer
Consilium Strategic Communications Tel: +44 (0)20
Mary-Jane Elliott/Matthew Neal/Philippa 3709 5700
Gardner/Laura Thornton/Rosie Phillips
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(R) ), 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.
This information is provided by RNS
The company news service from the London Stock Exchange
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