Oxford Biomedica PLC Kymriah receives positive CHMP opinion (1022T)
29 June 2018 - 10:37PM
UK Regulatory
TIDMOXB
RNS Number : 1022T
Oxford Biomedica PLC
29 June 2018
Kymriah (tisagenlecleucel, formerly CTL019) receives positive
CHMP opinion for the treatment of two aggressive blood cancers,
marking important milestone for patients in Europe
London, UK - 29 June 2018: Oxford BioMedica plc ("Oxford
BioMedica" or "the Group") (LSE:OXB), a leading gene and cell
therapy group, today notes that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) adopted a positive opinion recommending approval of Novartis'
Kymriah(R) (tisagenlecleucel, formerly CTL019) - a novel one-time
treatment that uses a patient's own T cells to fight cancer. The
positive opinion includes two B-cell malignancies: B-cell acute
lymphoblastic leukaemia (ALL) that is refractory, in relapse
post-transplant or in second or later relapse in patients up to 25
years of age; and diffuse large B-cell lymphoma (DLBCL) that is
relapsed or refractory (r/r) after two or more lines of systemic
therapy in adults.
If approved by the European Commission, Kymriah will be the
first CAR-T cell therapy available in the European Union (EU) for
both DLBCL and B-cell ALL
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.
- 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/ 3709 5700
Oliver Manser/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, Axovant,
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 positive CHMP opinion 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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END
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