Oxford Biomedica Regulatory News (OXB)

Oxford Biomedica notes announcement that FDA has lifted clinical hold on Homology Medicines' pheNIX trial

Oxford, UK - 14 June 2022: Oxford Biomedica plc (LSE:OXB) ("Oxford Biomedica" or "the Company"), a leading gene and cell therapy group, notes the recent announcement from Homology Medicines Inc. (Nasdaq: FIXX) ("Homology"), a genetic medicines company regarding the pheNIX gene therapy trial.

The U.S. Food and Drug Administration (FDA) has notified Homology that the clinical hold on its pheNIX gene therapy trial of HMI-102 in adults with phenylketonuria (PKU) has been lifted. As Homology previously disclosed, it received official notice of the clinical hold on March 17, 2022 and it pertained to elevated liver function tests observed in the trial, which were all resolved with no hospitalizations required. Homology's response to the FDA included changes to the protocol intended to enhance risk-mitigation measures, including a steroid-sparing immunosuppression regimen.

To view the full announcement from Homology Medicines please follow this link.

On 11 March 2022, Oxford Biomedica announced that it had completed its deal with Homology to establish Oxford Biomedica Solutions LLC ("Oxford Biomedica Solutions"), a new US-based full scope, Adeno-Associated Virus (AAV) manufacturing and innovation business. Oxford Biomedica Solutions, 20% owned by Homology, offers a unique 'Plug & Play' platform and fully integrated end-to-end capabilities, including from vector design and process development through to clinical trials. The transaction has enabled Oxford Biomedica to broaden its presence in the US, whilst offering future customers extensive manufacturing expertise in AAV, adenovirus and lentiviral-based cell and gene therapies. In addition, Oxford Biomedica Solutions is expected to generate a minimum first twelve months contracted revenues of approximately US$25 million from Homology under a three-year Manufacturing and Supply Agreement.

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Mary-Jane Elliott / Matthew Neal / Matthew Cole 

About Oxford Biomedica

Oxford Biomedica (LSE:OXB) is an innovative leading viral vector specialist focused on delivering life changing therapies to patients.

Oxford Biomedica plc and its subsidiaries (the Group) work across key viral vector delivery systems including those based on lentivirus, adeno-associated virus (AAV) and adenovirus, providing innovative solutions to cell and gene therapy biotechnology and biopharma companies for their process development, analytical development and manufacturing needs. Oxford Biomedica has built a sector leading lentiviral vector delivery system, LentiVector® platform, which the Group leverages to develop product candidates in-house, before seeking partners to take the products into clinical trials.

Oxford Biomedica is based across several locations and headquartered in Oxfordshire, UK. In early 2022, the Group established Oxford Biomedica Solutions, a new US based subsidiary AAV manufacturing and innovation business, based near Boston, US.

Oxford Biomedica employs more than 940 people. Further information is available at www.oxb.com.

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. The Company'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 (AAVHSCs) vectors 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 and broad intellectual property position the Company as a leader in genetic medicines. For more information, visit www.homologymedicines.com.