Unique platform offering capabilities from vector design and process development through to clinical trials is now available to new customers
Oxford, UK – 11 March 2022: Oxford Biomedica plc (LSE:OXB) (“Oxford Biomedica” or the “Company”), a leading gene and cell therapy group, is pleased to announce that it has completed its deal with Homology Medicines Inc. (Nasdaq: FIXX) (“Homology”), a genetic medicines company, to establish Oxford Biomedica Solutions LLC, a new US-based full scope, Adeno-Associated Virus (AAV) manufacturing and innovation business.
The new Oxford Biomedica Solutions business is fully operational and offers a proprietary ‘plug and play’ platform that is capable of achieving both high titre and high product quality vector for customers. The platform has already been proven with three separate new product INDs, and the process has been run successfully at representative scale more than 600 times. High titre, high product quality, proven expertise, and speed are the foundation of the platform, and this differentiated new offering.
The unique platform and fully integrated end-to-end capabilities, including from vector design and process development through to clinical trials, are now available to customers. This includes:
• Proprietary ‘plug and play’ process and manufacturing platform (i.e., same process for different transgenes and capsids) protected by intellectual property (IP)
• Team of approx.125 with complete end to end AAV expertise and experience
• 45+ successful 500L cGMP batches produced since 2019
• 3 x 500L single use bioreactors in multiple GMP suites operational
• Full CMC development scope: vector design, plasmid engineering, upstream, downstream, analytical development, formulation development
• cGMP operations scope: Manufacturing (Drug Substance & Drug Product), engineering, quality assurance, quality control, warehousing
• Platform successfully scaled to 2,000L
• Platform is a consistent and reliable serum free suspension cell culture and transfections system, and a two-column chromatography purification
Oxford Biomedica’s presence in the US, together with its existing UK-based business, offers customers extensive manufacturing expertise in AAV, adenovirus and lentiviral-based cell and gene therapies. Customers will also benefit from technical synergies brought in by the Company’s extensive innovations and a world-leading position in viral vector manufacturing.
Dr. Roch Doliveux, Chair and Interim CEO of Oxford Biomedica, commented: “We are delighted to have closed this transaction. Oxford Biomedica is transforming into an innovative global viral vector leader that provides solutions to cell and gene therapy biotech and biopharma companies for their process development and manufacturing needs. Our ambition is to become a leading partner of choice with advanced capabilities across key vector types. This transaction also sees us form our first US operating subsidiary, located close to customers, talent, innovation in academia and pools of capital, which will enhance our market leadership position working across key viral vector types.Oxford Biomedica is in a strong position to enable our customers to bring their new medicines to many more patients and change their lives.”
Tim Kelly, CEO of Oxford Biomedica Solutions, commented: “The team is excited to be able to offer this unique platform capability to help more companies and ultimately patients. The combination of our deep expertise, innovative platform technology, and dynamic team will make for a truly differentiated capability that I am confident will contribute to addressing some of the challenges being encountered in the cell and gene therapy space today, an area Oxford Biomedica knows well.”
Oxford Biomedica plc:
T: +44 (0)1865 783 000 / E: email@example.com
Stuart Paynter, Chief Financial Officer
Sophia Bolhassan, Head of Investor Relations
Consilium Strategic Communications:
T: +44 (0)20 3709 5700 / E: Oxfordbiomedica@consilium-comms.com
Mary-Jane Elliott / Matthew Neal
About Oxford Biomedica
Oxford Biomedica (LSE:OXB) is a leading, fully integrated, gene and cell therapy group. In January 2022, Oxford Biomedica announced that it was broadening its leading viral vector offerings by incorporating Homology Medicines’ established AAV capabilities into a newly formed AAV Manufacturing and Innovation Business in the US with Homology Medicines as a 20% owner. To date, 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, CNS disorders and liver diseases. The Group has also entered into a number of partnerships, including with Novartis, Bristol Myers Squibb, Boehringer Ingelheim, Beam Therapeutics, Arcellx, Cabaletta, Orchard Therapeutics and Santen, through which it has long-term economic interests in other potential gene and cell therapy products. Additionally, the Group has signed a 3-year master supply and development agreement with AstraZeneca for large-scale manufacturing of the adenoviral based COVID-19 vaccine, AZD1222. Oxford Biomedica is based across several locations in Oxfordshire, UK and employs more than 740 people. Further information is available at www.oxb.com.