London, UK – 7 May 2015: Oxford BioMedica plc (“Oxford BioMedica” or “the Group” or “OXB”) (LSE:OXB), a leading gene and cell therapy Group, today publishes its interim management statement for the period from 1 January to 7 May 2015.
Lentiviral vector based programmes
The results of the RetinoStat® Phase I study were announced at the Association for Research in Vision and Ophthalmology (ARVO) conference on 4 May 2015. The study met the primary endpoints of safety and tolerability. Patients also showed signs of clinical benefit, with visual acuity stabilisation and a reduction in vascular leakage consistent with the mechanism of endostatin and angiostatin function in vivo in this severe wet AMD population. OXB will now work with the Principal Investigators of the study as well as Key Opinion Leaders in the retinal field at the ARVO conference to determine the optimum future development path for the product. The data from the Phase I study will be published in a peer reviewed journal in due course.
The Group is working towards the start of a Phase I/II study for EncorStat® for the prevention of corneal graft rejection. The study, partially funded by an Innovate UK grant, is expected to start in 2016.
OXB 102 / Prosavin®
Also on 4 May 2015 Professor Stéphane Palfi MD, PhD gave an oral presentation at the American Association of Neurological Surgeons (AANS) conference of the results of the long term (three years) follow up of the 15 patients in the Phase I/II study of ProSavin. A significant improvement in mean unified Parkinson’s disease rating scale (UPDRS) part III motor scores in the off medication compared to baseline in all patients had been observed at six and 12 months. The follow up to date has shown that this improvement has been sustained in the majority of patients for up to three years in this progressively degenerative disease. The data supports the continued development of an enhanced construct of ProSavin®, OXB-102, as a treatment for advanced Parkinson’s disease.
The Group is now progressing OXB-102, which is at least five times more potent than Prosavin®, into clinical development utilising a £2.2 million grant from Innovate UK. Clinical trial material has been manufactured and the study is planned to start in 2016.
One Phase I/II and two Phase II investigator-sponsored studies are currently underway in the UK to assess the safety and immunological activity of Trovax® in patients with inoperable metastatic colorectal cancer, mesothelioma and ovarian cancer. All of these studies are using a biomarker to select patients for the studies. These studies are expected to report towards the end of 2015 and in 2016.
CAR-T 5T4 programme
The Group is developing a product which combines both its LentiVector® and 5T4 technology platforms. The product is based on a gene modified autologous T cell which is engineered using a lentiviral vector to express an antibody against 5T4. The T-cell would then be infused into the patient where it would recognise the 5T4 tumour antigen and trigger the “normal” T cell killing mechanisms which kill the cancer cell. This innovative approach directly primes the immune system against the 5T4 antigen, by presenting the antigen on T-cells which are responsible for detecting foreign antigens. This new product is currently in pre-clinical stage development.
OXB is in the process of expanding its Cowley, Oxford, manufacturing facility as well as opening a new manufacturing facility in Yarnton, Oxford. These developments will increase the physical space for manufacturing nearly five-fold and in addition there will be a new fill/finish facility. Work will also start soon on expanding and upgrading the laboratories at Windrush Court so that the Group can complete its move out of the Medawar Centre by March 2016. The Group expects to spend in the region of £20 million on these expansion plans during 2015 and 2016. The resulting capacity will allow the Group to meet its commitments to Novartis and also to offer services to other third parties.
On 1 May 2015 the Group announced that it had secured a $50 million loan facility from Oberland Capital Healthcare. The funds will be used to invest in the Group’s capacity expansion to enable it to deliver on commitments under its manufacturing agreement with Novartis and for pipeline advancements and product acquisitions. $25 million of the loan has been drawn down already, with the remaining funds available to be drawn down in minimum tranches of $5 million at the Group’s option prior to 31 December 2016. The AMSCI £5.3 million loan facility has been terminated and the £3 million drawn down to date has been repaid.
The Novartis contracts will generate significant manufacturing and process development revenues in 2015 and 2016 which will lead to the reduction of OXB’s underlying operational cash burn, and the Group is seeking similar contracts with other third parties. Critical to delivering these contracts is the expansion of the Group’s manufacturing and laboratory capacity. The recently-announced loan facility provides the finance necessary to get through the period of investment to the point at which the Group should become cash-generative.
Having secured the Novartis contracts in October 2014 and now underpinned the delivery of the capacity expansion programme with the Oberland loan facility, Oxford BioMedica remains focused on driving value through its gene and cell therapy product portfolio and opportunities, with four products currently in active clinical development, in parallel with delivering the contract with Novartis.
The Group is actively seeking further revenue-generating opportunities from licensing its technology and signing further process development and manufacturing contracts from third parties. The Group expects that, as more gene and cell therapy products enter clinical development, there will be demand from other companies for OXB’s manufacturing capabilities.
Oxford BioMedica will continue to expand its physical capacity during 2015 and in the first half of 2016 to ensure that it can meet the deliverables under the Novartis contract. By the end of 2016, profits from the OXB Solutions manufacturing and process development business should largely offset business overheads (excluding any product project funding requirements).
John Dawson, Chief Executive Officer of Oxford BioMedica, said: “I am delighted that we have managed to secure the Oberland loan facility as this removes any uncertainty concerning our financial position during our capacity expansion phase. We can now focus on delivering the Novartis contracts and, crucially for driving further shareholder value, making progress with our product portfolio. We continue to see very exciting potential with the current portfolio but also from new internal ideas and external opportunities.”
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