Oxford Biomedica Regulatory News (OXB)

Oxford BioMedica and Green Cross LabCell form a Partnership to Develop Gene-modified NK Cell Therapeutics in cancer

Unique combination of Oxford BioMedica's LentiVector® delivery platform and Green Cross LabCell's NK cell platform to generate a pipeline of differentiated products in cancer

Oxford, UK & Seoul, Korea - 2 June 2016: Oxford BioMedica plc ("Oxford BioMedica" or "the Group") (LSE: OXB), a leading gene and cell therapy group, today announces that it has entered into a Research & Development Collaboration with Green Cross LabCell ("GCLC"), a subsidiary of Green Cross Holdings, a leading South Korean biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. The collaboration will focus on identifying and developing gene modified natural killer (NK) cell-based therapeutics for treatment of life-threatening diseases such as cancer.

This collaboration brings together two clinically validated platform technologies with the aim of generating a pipeline of novel and differentiated cell-based products in areas of serious unmet medical need. Oxford BioMedica is contributing its clinically tested LentiVector® gene delivery platform for the efficient modification of immune cells, as well as its expertise in GMP bioprocessing, clinical development and regulatory affairs in ex vivo cell & gene therapy. GCLC is contributing its clinically tested platform for production of highly potent and activated NK cells.

During the initial Research Collaboration, Oxford BioMedica and GCLC (the "Parties") will collaborate to identify potential NK cell-based product candidates, modified using lentiviral vectors. The collaboration will focus on allogeneic CAR-NK cell-based products. Under the terms of the agreement, Oxford BioMedica and GCLC will share the costs associated with the Research Collaboration equally. Oxford BioMedica's contribution to the Research Collaboration will be funded from its existing Discovery resources and budget. The Parties will agree which product candidates from the Research Collaboration will be taken forward into the Development Collaboration stage of the programme on a product-by-product basis.

After nearly a decade of research on NK cells, GCLC has gathered a substantial body of evidence that their proprietary manufacturing platform for activated NK cells derived from peripheral blood mononuclear cells (PBMCs), such as MG4101, has potential to act as the basis for a pipeline of CAR-NK and other gene-modified NK cell products. By forming a partnership with GCLC, Oxford BioMedica gains access to one of the leading, clinically validated NK cell platforms in the industry and access to a highly skilled and experienced R&D partner in Korea, one of the most dynamic biotechnology markets in Asia.

Commenting on the new partnership, John Dawson, CEO of Oxford BioMedica, said: "We are very excited to form a key partnership with Green Cross LabCell, who have the industry-leading production platform for NK cell therapeutics for cancer. Over the years Green Cross LabCell has built a significant depth of scientific, technical and industrial expertise in NK cells that is difficult to find elsewhere.

"We are therefore delighted to be collaborating with Green Cross LabCell in a new partnership which brings our LentiVector® delivery platform and expertise to the relationship and which builds on our existing partnerships with other companies including Novartis, Sanofi, GSK and Immune Design. We believe that our collaboration will lead to the generation of a rich pipeline of novel gene-modified NK cell therapeutics for both companies."

Bok-Soo Park, Chief Executive Officer of Green Cross LabCell, commented "To work with Oxford BioMedica as our partner for the development and future commercialization of gene-modified NK cell products is exciting, given their world-leading expertise in the clinical development and bioprocessing of lentiviral vector based products. This agreement underscores our commitment to maximise the value of our technologies and accelerate their progress to the market through partnering with industry leaders. We chose to work with Oxford BioMedica as we believe they are best positioned to accelerate development of these programs and are fully committed to their success. We look forward to working with the team at Oxford BioMedica to bring desperately needed new treatment options to cancer to patients all around the world."

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Notes for editors

About Oxford BioMedica®

Oxford BioMedica (LSE:OXB) is a leading gene and cell therapy company 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®) through which the Group develops 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 and CNS disorders. The Group has also entered into a number of partnerships, including with Novartis, Sanofi, GSK, and Immune Design, 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 230 people. Further information is available at www.oxfordbiomedica.co.uk.

About Green Cross LabCell

Green Cross LabCell is a subsidiary of Green Cross Corp, a leading Korean pharmaceutical company with its headquarters in Seoul. Green Cross Corp. has annual sales of more than $1 billion across 14 marketed prescription products. The Company has been actively developing a number of new technologies and products in the emerging cell therapy industry. Its subsidiary, Green Cross LabCell is focused on clinical development of MG4101, a random donor PBMC-derived, ex vivo expanded and activated NK cell product in a number of Phase II clinical trials in Korea, as well as developing next generation gene-modified NK cell therapeutics. Green Cross LabCell operates its own GMP facilities in Seoul, Korea for production of NK cell based therapeutics. Its proprietary production platform enables allogeneic supply of therapeutic NK cells for multiple clinical trials. This technology platform holds the promise to dramatically reduce the cost of gene-modified cell therapies for cancer, while also aiding the quality control and industrial scale production of NK cell products.

About Oxford BioMedica's LentiVector® Delivery Platform

Oxford BioMedica has developed one of the most clinically validated gene therapy delivery systems based on lentiviruses. Its LentiVector® platform has been tested in more than 60 patients in clinical trials focussing on CNS and ophthalmology applications. In addition, via the Company's collaboration with Novartis in the field of CAR-T therapeutics, its vectors have been broadly used in the ex vivo setting for treating severe unmet medical needs in cancer.

About MG4101

MG4101 is a clinical stage cell-based product developed by Green Cross LabCell based on ex vivo expanded and activated NK cells derived from peripheral blood mononuclear cells from random healthy donors. MG4101 has completed a Phase I study in patients with a variety of terminal stage solid tumours and recurrent lymphoma patients (NCT01212341, Cancer Immunol Res. 2016 Mar;4(3):215-24.), a Phase II study in hepatocellular carcinoma (HCC) after resection (NCT02008929), and a Phase II study in paediatric solid tumours (NCT01807468). Another Phase II study in HCC after transarterial chemoembolization (TACE) will be start in Q3 2016. MG4101 and its associated production process provide the basis for the next generation of gene-modified NK cell therapeutics being jointly developed by Green Cross LabCell and Oxford BioMedica.