Oxford Biomedica PLC Findings from Phase II JULIET Study
June 14 2017 - 10:00AM
RNS Non-Regulatory
TIDMOXB
Oxford Biomedica PLC
14 June 2017
Oxford BioMedica Notes Findings on CTL019 from Phase II JULIET
Study Presented at the 14(th) Meeting of International Conference
on Malignant Lymphoma (ICML)
Oxford, UK - 14 June 2017: Oxford BioMedica plc ("Oxford
BioMedica" or "the Group") (LSE:OXB), a leading gene and cell
therapy group, today notes the findings reported by Novartis on its
global multi-centre Phase II JULIET study evaluating the efficacy
and safety of CTL019 (tisagenlecleucel-T), an investigational
chimeric antigen receptor T cell (CAR-T) therapy, in adult patients
with relapsed and refractory (r/r) diffuse large B-cell lymphoma
(DLBCL). The study met its primary objective at interim
analysis.
Oxford BioMedica is the sole manufacturer of the lentiviral
vector expressing CTL019 for Novartis. The commercial launch of
CTL019 is anticipated by Novartis later this year and Oxford
BioMedica will receive undisclosed royalties on potential future
sales of Novartis CAR-T products.
The findings were presented during an oral session at 15:40 CET
on Wednesday 14(th) June 2017 at the 14(th) International
Conference on Malignant Lymphoma (ICML) meeting (Abstract
#007).
Novartis reported the interim analysis of the global
multi-centre Phase II JULIET study which showed a 3-month Overall
Response Rate (ORR) of 45% (23 of the 51 patients evaluated), with
37% achieving a Complete Response (CR) and 8% achieving a Partial
Response (PR), respectively. CR remained stable from three months
through data cut off among the patient group. Among 51 patients
with >3 month follow-up or earlier discontinuation, best ORR was
59% (95% CI, 44%-72%; P<0.0001) with 43% achieving CR and
achieving 16% PR. CR and PR rates at 3 months were 37% and 8%
respectively. Cytokine Release Syndrome (CRS) occurred in 57% of
infused patients (17% grade 3, 9% grade 4); no CRS associated
deaths occurred. No cerebral oedema was reported. Three patients
died from disease progression, within 30 days of infusion. No
deaths were attributed to CTL019. The abstract is available online
here:
http://onlinelibrary.wiley.com/doi/10.1002/hon.2437_6/full.
The overall response rate seen in this early analysis is
impressive for these heavily pre-treated patients with
relapsed/refractory DLBCL, who have limited treatment options. The
full JULIET primary analysis is expected to be available later this
year and will serve as the basis for US and EU regulatory
submissions.
John Dawson, Chief Executive Officer of Oxford BioMedica,
commented: "We are pleased that Novartis has reported these
additional strong data with CTL019 in another indication, r/r
DLBCL, which is a much larger target patient population than for
r/r ALL. We continue to work closely with Novartis in delivering
the lentiviral vector across their CTL019 pipeline/franchise, a
product group described earlier this year, by Novartis, as having
"blockbuster" potential."
-Ends-
For further information, please contact:
Oxford BioMedica plc: Tel: +44 (0)1865 783 000
John Dawson, Chief Executive Officer
Tim Watts, Chief Financial Officer
Financial PR Enquiries: Tel: +44 (0)20 3709 5700
Mary-Jane Elliott / Matthew Neal / Chris Welsh / Laura
Thornton
Consilium Strategic Communications
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 250 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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