Oxford Biomedica Regulatory News (OXB)

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Oxford Biomedica Signs Five Year Collaboration Agreement with the Vaccines Manufacturing and Innovation Centre

Oxford, UK - 8 June, 2020: Oxford Biomedica plc (LSE:OXB) ("Oxford Biomedica" or "the Group"), a leading gene and cell therapy group, announced today that it has signed a Collaboration Agreement ("the Agreement") with the Vaccines Manufacturing and Innovation Centre (VMIC), a not-for-profit organisation established to provide the UK's first strategic vaccine development and advanced manufacturing capability. This five year Agreement will involve the organisations working collaboratively to enable the manufacture of viral vector based vaccines, contributing towards a rapid increase in UK domestic capacity for this specialised field of vaccine manufacturing.

Both Oxford Biomedica and VMIC are original members of the Oxford University manufacturing consortium focussed on scaling-up the GMP manufacture of the adenovirus vector based COVID-19 vaccine candidate, AZD1222 (previously known as ChAdOx1 nCoV-19), which has entered clinical trials at multiple sites in the UK. AstraZeneca has now taken over global responsibility for the manufacturing, development and distribution for AZD1222 with an initial clinical and commercial supply agreement for multiple batches signed between AstraZeneca and Oxford Biomedica on the 28 May.

As part of the Collaboration Agreement, VMIC will provide manufacturing equipment for Oxford Biomedica to rapidly equip two new GMP manufacturing suites within Oxford Biomedica's new 7,800 m2 commercial manufacturing centre, Oxbox, located in Oxford, UK. This will provide significant additional manufacturing capacity and enable further scale up for AZD1222 from the summer of 2020 as needed to help supply UK and European vaccine demand. These suites could also potentially be utilised for other viral vector vaccine candidates. As part of the Agreement, Oxford Biomedica will provide training and technical assistance to VMIC staff to accelerate the operational readiness and GMP manufacturing capabilities for viral vector vaccine candidates at VMIC's new manufacturing site located at the Harwell Science and Innovation Campus. The VMIC facility is due to open in mid-2021, a year ahead of schedule.

The Agreement also provides a framework for a longer-term partnership between Oxford Biomedica and VMIC, whereby Oxford Biomedica could rapidly provide its commercial scale manufacturing capacity to supply other novel viral vector vaccine candidates for the UK population, when needed.

John Dawson, Chief Executive Officer of Oxford Biomedica, said: "Since we became involved in addressing the urgent need for UK manufacturing capacity for AstraZeneca's COVID-19 vaccine candidate AZD1222, we have strived to support VMIC's broader goal of accelerating and supporting UK manufacturing capacity and capabilities for vaccines more generally. This highly collaborative partnership allows for a rapid deployment capability to be established, and also accelerates fit out and utilisation of another two GMP manufacturing suites within our new commercial manufacturing facility, Oxbox."

Matthew Duchars, Chief Executive Officer of Vaccines Manufacturing Innovation Centre, said: 

"This collaboration with Oxford Biomedica means that together we can significantly increase the UK's capacity to manufacture viral vectors vaccines as part of a national effort in response to COVID-19. This marks a major milestone for VMIC in setting up collaborative partnerships with industry - this is the first collaboration agreement outside of our founding partners under VMIC's longer term objective of boosting the UK's vaccines manufacturing capability."

Kate Bingham, Chair of the UK Vaccine Taskforce, said: "The Government is backing the Vaccines Manufacturing and Innovation Centre as a crucial part of securing long-term vaccine manufacturing capability in the UK. Viral vector Covid-19 vaccine candidates are showing significant promise. This new partnership between VMIC and Oxford Biomedica marks a major milestone in increasing the UK manufacturing capacity of viral vector vaccines and will specifically help ensure that we have the right skills in place to manufacture a vaccine as soon as one is available."

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About Oxford Biomedica

Oxford Biomedica (LSE:OXB) is a leading, fully integrated, 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®), 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, CNS disorders, liver diseases and respiratory disease. The Group has also entered into a number of partnerships, including with Novartis, Bristol Myers Squibb, Sanofi, Axovant Gene Therapies, Orchard Therapeutics, Santen, Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium and Imperial Innovations, through which it has long-term economic interests in other potential gene and cell therapy products. Additionally the group has signed a Clinical and Commercial Supply Agreement with AstraZeneca for manufacture of the adeno based COVID-19 vaccine candidate, AZN1222. Oxford Biomedica is based across several locations in Oxfordshire, UK and employs more than 550 people. Further information is available at www.oxb.com

About Oxbox

Oxbox is Oxford Biomedica's new 7,800 m2 commercial manufacturing centre, located in Oxford, UK. Phase I, which became operational in 2020, is 4,200 m2 of developed area consisting of six GMP clean room suites - four for vector production and two for fill-finish, warehousing and cold chain facilities and support laboratories. The Company received MHRA approval for the first two suites in Oxbox last month. Phase II will provide for flexible expansion for a further six GMP clean room suites. This world class facility is expected to more than double Oxford Biomedica's manufacturing capacity, supporting further growth in revenues.

About the Vaccines Manufacturing and Innovation Centre (VMIC)VMIC is part of the national science infrastructure and has been established to fast track the development and manufacture of early stage vaccines for known diseases, and to serve as the UK's response to emerging infectious diseases. VMIC was founded in 2018 by the University of Oxford, Imperial College and London School of Hygiene and Tropical Medicine with support from industrial partners, MSD, Johnson and Johnson, and Cytiva, formerly GE Life Sciences. VMIC's 7,000 m2 state-of-the-art vaccines manufacturing facility will open in 2021 following a rapidly accelerated development schedule and will be located on the Harwell Science and Innovation Campus in Oxfordshire. The Centre's main funding comes from UK Research and Innovation, as part of the UK Government's Industrial Strategy Challenge Fund, with further contributions provided by industry partners and other businesses. More information can be found at www.vmicuk.com

The person who arranged for the release of this announcement on behalf of Oxford Biomedica plc was John Dawson, Chief Executive Officer.