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Oxford, UK – 16 November 2011: Oxford BioMedica plc (“Oxford BioMedica” or “the Company”) (LSE: Oxford Biomedica), the leading gene-based biopharmaceutical company, today publishes its interim management statement for the period from 1 July to 15 November 2011.
PIPELINE UPDATE
LentiVector® platform
ProSavin® (gene-based therapy for Parkinson’s disease): development update
- Treatment of all six patients in fourth cohort complete
- Review of all four cohorts by the Data Monitoring Committee will be in December 2011
Ocular programmes (gene-based therapies targeting vision loss): partnered with Sanofi
- RetinoStat® Phase I study: second ascending dose cohort complete
- StarGen™ Phase I/IIa study: on-going with second site initiated in France
- FDA approval received for UshStat® investigational new drug (IND) application in October 2011, Phase I/IIa study expected to be initiated by the end of 2011
- Pre-IND meeting with FDA held in September 2011 for EncorStat®
New gene-based therapy for chronic glaucoma: in collaboration with Mayo Clinic
- R&D agreement announced in October 2011
Manufacturing
- Re-commissioning of new lentiviral vector facility is on track, expected to be fully-operational in H1 2012
5T4 tumour antigen platform
Targeted antibody therapy for cancer: partnered with Pfizer
In September 2011, Pfizer presented new data at the ISREC Symposium which confirmed that 5T4 is the single oncology target for the antibody-drug conjugate (ADC) technology licensed from Seattle Genetics earlier this year. The Oncology Research Unit has synthesised an anti-5T4 antibody-drug conjugate (ADC), called A1-mcMMAF, and has shown that A1-mcMMAF can eradicate tumor cells that have heterogeneous expression of 5T4. As previously announced, Oxford BioMedica has licensed the exclusive, global right to market antibodies targeting the 5T4 tumour antigen for all human cancer indications to Pfizer. The next milestone payment to Oxford BioMedica would be due if Pfizer initiates clinical trials.
FINANCIAL REVIEW
The Company’s net cash balance1 at 30 June 2011, as stated in the interim report, was £20.2 million. At 31 October 2011 the Company had a net cash1 balance of £17.5 million. Both figures are unaudited.
1 Cash, cash equivalents and current financial assets
OUTLOOK
Oxford BioMedica continues to focus on delivering progress across its core programmes having advanced two ocular gene therapies into clinical development and agreed a new R&D collaboration for glaucoma with a worldwide leader in medical research during 2011. With innovative technology platforms, world-class industry collaborations and data expected from its pioneering clinical studies throughout 2012, the Company looks forward to encouraging prospects ahead.
John Dawson, Chief Executive Officer of Oxford BioMedica, said: “Developing pioneering gene therapy programmes demands a significant amount of R&D, regulatory, manufacturing and commercial expertise and, with five clinical programmes expected to be underway by the end of 2011, we are pleased with our achievements this year. With clear strategic priorities ahead, all efforts remain focused on leveraging the potential of our novel technology platforms.”
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