RCS - Oxford Biomedica PLC - Notes FDA lift clinical hold on pheNIX trial

Oxford BioMedicaAnnouncement

14/06/2022 07:00

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RNS Number : 7260O  Oxford Biomedica PLC  14 June 2022

 

 

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
(https://www.homologymedicines.com/news-story/homology-medicines-announces-fda-lifted-clinical-hold-on-phenix-gene-therapy-trial-for-pku)
.

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.

-Ends-

 

Enquiries:

 

Oxford Biomedica plc: T: +44 (0)1865 783 000 / E: ir@oxb.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 / 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 (http://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.

 

 

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