Oxford Biomedica PLC Kymriah receives FDA approval for DLBCL (8213M)
02 May 2018 - 4:00PM
UK Regulatory
TIDMOXB
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(R) (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.
- 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
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, 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(R) (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
The company news service from the London Stock Exchange
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