Oxford Biomedica PLC Axovant FDA meeting feedback

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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

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 For further information, please contact: 
  Oxford BioMedica plc:                            Tel: [phone] 
   John Dawson, Chief Executive Officer             783 000 
   Stuart Paynter, Chief Financial Officer          [e-mail] 
   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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December 06, 2018 11:11 ET (16:11 GMT)