Oxford BioMedica PLC (OXBDF)

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Oxford Biomedica PLC Axovant FDA meeting feedback
06/12/2018 4:11pm
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