Summary :
- Oxford Biomedica and Homology Medicines to establish Oxford Biomedica Solutions LLC, a new U.S.-based AAV Manufacturing and Innovation Business
- Homology Medicines to receive $130 million from Oxford Biomedica to continue to advance its three clinical programs and genetic medicines platform
- Oxford Biomedica to invest $50 million to fund the growth of Oxford Biomedica Solutions LLC and will own 80%, with Homology Medicines to own 20%; Homology Medicines to secure preferred key customer status
- Dr. Roch Doliveux to become Interim CEO of Oxford Biomedica and John Dawson to retire as CEO and remain a Board Director of Oxford Biomedica
- Oxford Biomedica and Homology Medicines to host webcasts today to discuss the announcement
Leading gene and cell therapy group, Oxford Biomedica, and Homology Medicines, have announced that the companies will establish a high-performing Adeno-Associated Virus (AAV) Manufacturing and Innovation Business in the US.
Oxford Biomedica aims to establish a presence across the pond and will offer pharmaceutical and biotechnology manufacturing expertise in AAV and lentiviral-based gene therapies. In addition, the deal will provide access to Homology’s proven end-to-end manufacturing toolbox.
Oxford Biomedica and Homology Medicines to host webcasts today to discuss the announcement
Under the terms of the agreement, Oxford Bionmedica will pay Homology $130m upfront and invest $50m to fund Oxford Biomedica Solutions, in return for an 80% ownership stake, while Homology will also own 20% of the new company. The transaction is expected to close in the first quarter of 2022, depending on the satisfaction of certain closing conditions.
Dr Roch Doliveux, Chair and interim CEO of Oxford Biomedica, commented on the development: “Accessing Homology Medicines’ unique AAV capabilities is a major advancement in Oxford Biomedica’s goal to become an innovative global viral vector leader that provides solutions to Cell and Gene Therapy (C>) Biotech and Biopharma companies for their process development and manufacturing needs across key viral vectors.
Oxford Biomedica Solutions’ AAV Manufacturing and Innovation Business is to be led by Tim Kelly as Chief Executive Officer and Chair of its Board of Directors. Tim is currently the Chief Operating Officer of Homology, where he and his team were responsible for building and leading Homology’s internal technical and manufacturing operations, which will become Oxford Biomedica Solutions and incorporate the following:
- Proprietary ‘plug and play’ process development and manufacturing platform (i.e., same process for different transgenes and capsids) protected by intellectual property (IP);
- 125 AAV manufacturing experts who encompass the full CMC scope of upstream and downstream process development, analytical development, manufacturing operations and quality control;
- Experienced team and high-quality GMP vector production capabilities that has been operating since 2019 without a single failed batch;
- Over 40 analytical assays developed and an established breadth of vector characterization that has met CMC requirements for three cleared Investigational New Drug applications (INDs) from Homology’s pipeline; and
- A GMP facility near Boston, Massachusetts, operating three 500-liter bioreactors using a serum-free suspension process, which has also been successfully scaled to 2,000 liters.
Under the terms of the agreement, the Group will pay Homology $130 million upfront and invest $50 million to fund Oxford Biomedica Solutions in return for an 80 percent ownership stake, while Homology will own 20 percent of the new company. Additionally, at any time following the three-year anniversary of the agreement, the Group will have a call option to purchase, and Homology will have a put option to require the Group to purchase, Homology’s ownership interest in Oxford Biomedica Solutions.
The transaction is expected to close in Q1 2022, subject to the satisfaction of certain closing conditions including the requirements of the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
Simultaneous to this announcement, Dr. Roch Doliveux will assume the role of interim CEO of Oxford Biomedica, as well as Chair of the Group’s Board, and John Dawson will retire from the Group as CEO with immediate effect, while remaining a Board Director and Advisor to the Group. A search for a CEO successor is underway, as previously announced by the Group.
Dr. Roch Doliveux, Chair and Interim CEO of Oxford Biomedica, commented: “Accessing Homology Medicines’ unique AAV capabilities is a major advancement in Oxford Biomedica’s goal to become an innovative global viral vector leader that provides solutions to Cell and Gene Therapy (C>) Biotech and Biopharma companies for their process development and manufacturing needs across key viral vectors. Process Development/CMC being one of the most important critical success factors to ensure efficacy, safety and affordability of C>, Oxford Biomedica is in a strong position to enable our customers to bring their new medicines to many more patients and change their lives. We look forward to working with Homology’s impressive team and uniquely robust processes to achieve world-leadership as a provider of AAV solutions in addition to enhancing our leadership in lentiviral vectors. Having a U.S. base brings us closer to customers, talent, innovation in academia and pools of capital all of which will allow growth and building a market leadership position.”
Arthur Tzianabos, Ph.D., President and Chief Executive Officer of Homology Medicines, said: “We chose Oxford Biomedica for its leadership in viral-based manufacturing and prestigious global client base, and we believe that Oxford Biomedica Solutions will build upon the strengths of both companies. Our leadership in AAV process development and CMC, which resulted from establishing internal capabilities early on, has enabled us to advance three programs from discovery into the clinic within five years. We believe the opportunity in Oxford Biomedica Solutions further leverages the value we created in this broad capability, including the demonstrated expertise of our team, to provide much-needed high-quality viral vector to other companies and, importantly, more patients around the world. Additionally, the $130 million cash infusion, coupled with the reduction in operating expenses, significantly extends our runway and supports the continued advancement of our programs and genetic medicines platform. We believe our ownership stake in Oxford Biomedica Solutions, continued access to our AAV ‘plug and play’ manufacturing platform as a preferred customer, and our ability to benefit from any further manufacturing innovations, will be key value drivers for Homology.”
Dr. Roch Doliveux commenting on John’s departure added: “I would like to express my sincere appreciation for John Dawson’s leadership and achievements as CEO. He and the world-class management team he has built have worked relentlessly in selecting the best AAV partner and creating this potentially transformative deal for the Group. This makes it easier to support John’s decision to step down at this time. I am delighted that he will remain a Board member and Advisor.”
John Dawson, CBE, added: “I am excited that this will be my final deal as CEO of the Group. This transaction not only brings proven, scalable, high-quality AAV manufacturing capabilities to Oxford Biomedica, which was in line with our strategy, but also expands Oxford Biomedica’s presence into the U.S. and brings us a dedicated team in close geographic proximity to other leading gene therapy companies in Boston and more widely across the U.S.”
He added: “Process Development/CMC being one of the most important critical success factors to ensure efficacy, safety and affordability of C>, Oxford Biomedica is in a strong position to enable our customers to bring their new medicines to many more patients and change their lives.
“We look forward to working with Homology’s impressive team and uniquely robust processes to achieve world-leadership as a provider of AAV solutions in addition to enhancing our leadership in lentiviral vectors. Having a US base brings us closer to customers, talent, innovation in academia and pools of capital all of which will allow growth and building a market leadership position.”
Homology Medicines Webcast
Homology management will host a webcast today, January 28, 2022, at 8:00 a.m. ET to discuss the transaction and provide an update on its clinical programs and product pipeline. The webcast will be accessible on Homology’s website in the Investors section, and the webcast replay will be available on the website for 90 days following the presentation. To access using the conference call line, dial (866) 244-8091 (U.S./Canada toll-free) or +1 (602) 563-8623, with Conference ID 9734109.
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, Boehringer Ingelheim, Arcellx and Cabaletta, 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
About Homology Medicines, Inc.
Homology Medicines, Inc. is a clinical-stage genetic medicines company dedicated to transforming the lives of patients suffering from rare diseases by addressing the underlying cause of the disease. Homology’s clinical programs include HMI-102, an investigational gene therapy for adults with phenylketonuria (“PKU”); HMI-103, a gene editing candidate for PKU; and HMI-203, an investigational gene therapy for Hunter syndrome. Additional programs focus on metachromatic leukodystrophy (“MLD”), paroxysmal nocturnal hemoglobinuria (“PNH”) and other diseases. Homology’s proprietary platform is designed to utilize its family of 15 human hematopoietic stem cell-derived adeno-associated virus vectors (“AAVHSCs”) to precisely and efficiently deliver genetic medicines in vivo through a gene therapy or nuclease-free gene editing modality, as well as to deliver one-time gene therapy to produce antibodies throughout the body through the GTx-mAb platform. Homology has a management team with a successful track record of discovering, developing and commercializing therapeutics with a focus on rare diseases. Homology believes its initial clinical data and compelling preclinical data, scientific and product development expertise, internal manufacturing capabilities and broad intellectual property position Homology as a leader in genetic medicines