Oxford Biomedica Regulatory News (OXB)

Oxford Biomedica notes interim results from AstraZeneca on AZD1222 showing strong antibody and T-cell responses and acceptable safety profile

Oxford, UK - 20 July, 2020: Oxford Biomedica plc (LSE:OXB) ("Oxford Biomedica" or "the Group"), a leading gene and cell therapy group, notes that AstraZeneca UK Ltd ("AstraZeneca") has announced interim results from the ongoing Phase I/II COV001 trial, led by Oxford University on AZD1222 which showed the SARS-CoV-2 vaccine candidate AZD1222 was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants.

COV001 is a blinded, multi-centre, randomised controlled Phase I/II trial with 1,077 healthy adult participants, aged 18-55 years. It assessed a single dose of AZD1222 against a comparator meningococcal conjugate vaccine, MenACWY. Ten participants also received two doses of AZD1222 one month apart.

The results published in The Lancet confirmed a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection. In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection.

Neutralising activity against SARS-CoV-2 (as assessed by the MNA80 assay) was seen in 91% of participants one month after vaccination and in 100% of participants who received a second dose. The levels of neutralising antibodies seen in participants receiving either one or two doses were in a similar range to those seen in convalescent COVID-19 patients. Strong correlations were observed across neutralisation assays.

To view the full announcement from AstraZeneca please follow this link

As announced on 28 May 2020, Oxford Biomedica has signed a one year Clinical & Commercial Supply Agreement with AstraZeneca who will have access to Oxford Biomedica's new 7,800 m2 commercial manufacturing centre Oxbox, located in Oxford, UK. The initial agreement requires Oxford Biomedica to provide AstraZeneca with multiple batches of vaccine, the majority of which are expected to be produced throughout 2020. The production will be from one of the Group's recently approved GMP suites in Oxbox.

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About Oxford BiomedicaOxford 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. Oxford Biomedica is based across several locations in Oxfordshire, UK and employs more than 550 people. Further information is available at http://www.oxb.com/

About Oxbox

Oxbox is Oxford Biomedica's new 7,800 m2 commercial manufacturing centre, located in Oxford, UK. Phase I, which will be operational in 2020, is 4,200 m2 of developed area consisting of six Good Manufacturing Practices ("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 in May this year. 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.