Oxford Biomedica sees FDA lift clinical hold on Homology's HMI-102 trial

14th Jun 2022 09:35

(Sharecast News) - Gene and cell therapy group Oxford Biomedica said on Tuesday that the US Food and Drug Administration had notified Homology Medicines that the clinical hold on its pheNIX gene therapy trial of HMI-102 in adults with phenylketonuria had been lifted.

Homology previously received official notice of the clinical hold on the trial back on 17 March following elevated liver function tests observed in the trial, which were all resolved with no hospitalisations.

The FTSE 250-listed firm noted that 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, Oxford Biomedica completed a deal with Homology to establish Oxford Biomedica Solutions, a new US-based full scope, adeno-associated virus manufacturing, and innovation business.

Oxford Biomedica stated the transaction had enabled the group to broaden its presence in the US, whilst offering future customers extensive manufacturing expertise in AAV, adenovirus and lentiviral-based cell and gene therapies. Oxford Biomedica Solutions was expected to generate a minimum first twelve months contracted revenues of approximately $25.0m from Homology under a three-year manufacturing and supply agreement.

As of 1000 BST, Oxford Biomedica shares were down 3.23% at 436.42p.

Reporting by Iain Gilbert at Sharecast.com