Oxford Biomedica PLC Axovant FDA meeting feedback
December 06 2018 - 11:11AM
RNS Non-Regulatory
TIDMOXB
Oxford Biomedica PLC
06 December 2018
Oxford BioMedica notes Axovant announcement of feedback from FDA
regarding AXO-LENTI-PD and progress with ongoing Phase 2 clinical
trial
Oxford, UK - 06 December 2018: Oxford BioMedica plc ("Oxford
BioMedica" or "the Group") (LSE:OXB), a leading gene and cell
therapy group, notes an announcement today by Axovant Sciences
regarding feedback from a face-to-face pre-IND meeting with the
U.S. Food and Drug Administration (FDA) concerning AXO-Lenti-PD for
patients with Parkinson's disease. Based on the discussion at the
FDA meeting, the totality of data collected on the initial vector
construct, ProSavin, including over six years of phase 1/2 clinical
data and IND-enabling preclinical data, may be supportive of the
planned development programme for AXO-Lenti-PD.
In addition, the phase 2 clinical trial of AXO-Lenti-PD
(NCT03720418), now called SUNRISE-PD, was initiated in the U.K. in
the fourth quarter of 2018. The SUNRISE-PD study is advancing as
planned with dosing of the second patient in November 2018. To
date, both patients have tolerated the surgical procedure well and
were discharged home with no serious adverse events observed.
Axovant expects to announce data from the first two patients in
March 2019.
Under the terms of the agreement with Axovant, Oxford BioMedica
received a $30 million upfront payment (approximately GBP22
million) including $5 million as pre-payment for manufacturing
activities related to OXB-102, now renamed AXO-Lenti-PD. Oxford
BioMedica is also eligible to receive $55 million upon the
achievement of specified development milestones and $757.5 million
upon the achievement of specified regulatory and sales milestones,
with 7% to 10% tiered royalties on net sales of AXO-Lenti-PD.
Read the Axovant press release here
- 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 media@oxb.com
Sarah MacLeod, Head of Communications
Consilium Strategic Communications Tel: +44 (0)20
Mary-Jane Elliott/Matthew Neal/Laura Thornton 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(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, Boehringer Ingelheim/UK Cystic Fibrosis Gene
Therapy Consortium/Imperial Innovations and GC LabCell, 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 360 people.
Further information is available at www.oxb.com.
About AXO-Lenti-PD
AXO-Lenti-PD, also known as OXB-102, is an investigational gene
therapy for Parkinson's disease that delivers three genes in vivo
via a lentiviral vector to encode a critical set of enzymes
required for dopamine synthesis in the brain and is designed to
provide patient benefit for many years following a single
administration. AXO-Lenti-PD is a next-generation gene therapy
designed to further increase endogenous dopamine production over
the first-generation product, Prosavin, by modifying the payload
configuration. Preclinical studies directly comparing AXO-Lenti-PD
to ProSavin demonstrate increased AADC activity and dopamine
productivity of the new vector configuration. Oxford BioMedica has
successfully completed a phase I/II study for ProSavin(R), which
met its primary endpoint. The results, which were published in The
Lancet in 2014, demonstrate favorable safety and tolerability and a
statistically significant improvement from baseline of motor
function as measured by the UPDRS Part III score at 6 and 12
months. This improvement has been observed to be sustained in
patients for up to six years despite the progressively degenerative
nature of Parkinson's disease. Initial data from the ongoing
AXO-Lenti-PD clinical program is expected in the first half of
2019.
About Axovant Sciences
Axovant is a clinical-stage gene therapy company focused on
developing a pipeline of innovative product candidates for
debilitating diseases such as Parkinson's disease, oculopharyngeal
muscular dystrophy, Duchenne muscular dystrophy, ALS,
frontotemporal dementia, and other indications. For more
information, visit www.axovant.com.
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