Oxford Biomedica Announces that Boehringer Ingelheim has Exercised Option Relating to a Novel Gene Therapy Treatment for Cystic Fibrosis

Oxford, UK - 19 October 2021: Oxford Biomedica plc (LSE:OXB) ("Oxford Biomedica" or "the Group"), a leading gene and cell therapy group, today announces that Boehringer Ingelheim has exercised its option to license Oxford Biomedica's lentiviral vector technology to manufacture, register and commercialise BI 3720931, a lentiviral vector-based gene therapy for the treatment of cystic fibrosis (CF).

Under the terms of the option and license agreement with Boehringer Ingelheim, originally announced in August 2018, Boehringer Ingelheim will pay Oxford Biomedica an option exercise fee of £3.5 million. Oxford Biomedica is further entitled to development, regulatory and sales milestones of up to a further £27.5 million, in addition to a tiered low single digit royalty on net sales of a CF gene therapy product. This option exercise by Boehringer Ingelheim follows on another recent signature of a Development & Supply Agreement which was announced in April 2021, relating to the clinical manufacture of various types of viral vector based products.  

In parallel, Boehringer Ingelheim has also exercised its option to license intellectual property and know-how from IP Group and the UK Cystic Fibrosis Gene Therapy Consortium relating to the same lentiviral vector-based product candidate for the treatment of CF.

This innovative development partnership between academia, Pharma and Biotech focuses on the development of a novel, replication deficient lentiviral vector, in an inhaled formulation, to selectively introduce a CFTR gene into the relevant target cell. This approach has demonstrated high gene transfer efficiency and offers the possibility of repeated administration to maintain a therapeutic effect. In addition, the approach has the potential to address all of the more than 2,000 different known gene mutations across CF patients, and therefore offers a gene-independent disease-modifying treatment option for patients.

Should the program progress into clinical development, Oxford Biomedica expects to produce large quantities of lentiviral vectors using its highly efficient GMP-compliant manufacturing process in bioreactors.

To read the full Boehringer Ingelheim press release please follow this link: http://www.boehringer-ingelheim.com/press-release/cystic-fibrosis-genetherapy-development-option-excercise

John Dawson, Chief Executive Officer of Oxford Biomedica, said: "We have enjoyed working with Boehringer Ingelheim, IP Group, and the UK Cystic Fibrosis Gene Therapy Consortium since 2018. Building on the great progress made to date, we are delighted that Boehringer Ingelheim, one of the world's leading respiratory medicine organisations, has chosen to exercise the option to license Oxford Biomedica's lentiviral vector manufacturing technology for this highly innovative inhaled cystic fibrosis gene therapy formulation developed by the UK Cystic Fibrosis Gene Therapy Consortium. This partnership is central to our company's mission of delivering life changing gene therapies to patients and has the potential to provide a new therapeutic option for many cystic fibrosis patients globally."

Clive R. Wood, Ph.D., Corporate Senior Vice President and Global Head of Discovery Research at Boehringer Ingelheim, said: "Since 2018, Boehringer Ingelheim has sponsored research and development activities with the UK Cystic Fibrosis Gene Therapy Consortium and Oxford Biomedica. The shared success achieved with our partners in this potentially revolutionary project makes us confident that we can now further accelerate this highly innovative therapeutic approach. With our leadership in the discovery and development of therapies in respiratory diseases combined with the gene therapy and manufacturing knowledge of our partners, we aim to bring the next breakthrough to patients suffering from CF, who are desperately waiting for better options."

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Enquiries:       

Oxford Biomedica plc: T: +44 (0)1865 783 000 / E: [email protected]

John Dawson, Chief Executive Officer

Stuart Paynter, Chief Financial Officer

Sophia Bolhassan, Head of Investor Relations

Consilium Strategic Communications: T: +44 (0)20 3709 5700

Mary-Jane Elliott / Matthew Neal            

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, CNS disorders and liver diseases. The Group has also entered into a number of partnerships, including with Novartis, Bristol Myers Squibb, Sio Gene Therapies, Orchard Therapeutics, Santen, Beam Therapeutics and Boehringer Ingelheim, 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 candidate, 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 

About Boehringer Ingelheim

Boehringer Ingelheim is working on breakthrough therapies that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Around 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. Learn more at www.boehringer-ingelheim.com

About Cystic Fibrosis

Cystic Fibrosis is a rare, progressive, life-threatening disease that results in severe dysfunction and persistent infections of the lung affecting 70,000 people worldwide. It is caused by a defective or absent protein that results from mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. This innovative development partnership among academia, life science investors, pharma, and biotech focusses on the advancement of BI 3720931, a novel, replication deficient lentiviral vector, in an inhaled formulation, which selectively introduces a healthy CFTR gene into the relevant target cells.