FDA lifts clinical hold on Homology Medicines’ pheNIX 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, it said. Homology’s response to the FDA included changes to the protocol intended to enhance risk-mitigation measures, including a steroid-sparing immunosuppression regimen.

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.