The following two biomedical companies – Gyroscope Therapeutics in Stevenage UK and Orbit Biomedical in Philadelphia, US – have announced that they have merged in a combined entity to build “precise and targeted delivery of gene and cell therapies into the retina”. The company will maintain the Gyroscope name, and the press release has stated that “the organization will become the first fully-integrated retinal gene therapy company with clinical, manufacturing and delivery capabilities”. Gyroscope has built to a gene therapy company focused on AMD while Orbit Biomedical calls itself a company that works in “the intersection of biomedical engineering, surgeon training and curative therapeutics.” Both companies were part of the Syncona investment group set up by the Wellcome Trust, Cancer Research UK, academic institutions and industry.
Gyroscope has recently initiated a Phase I/II clinical trial in dry age-related macular degeneration (AMD), set up as an open label, dose escalation, multi-centre study to assess the safety and biological activity of a novel therapeutic approach (GT005). The therapeutic is an rAAV2 delivery vector comprising a nucleotide sequence encoding CFI (complement factor I) (rAAV2.CFI) and the study is formally entitled: “FOCUS: An open label first in human Phase 1/2 multicentre study to evaluate the safety, dose response and efficacy of GT005 administered as a single subretinal injection in subjects with Macular Atrophy due to Age-related Macular Degeneration” (www.clinicaltrialsregister.eu).
Chris Hollowood, Chief Investment Officer of Syncona and Chairman of Gyroscope, said: “Gyroscope is one of the first companies globally to move gene therapy out of rare diseases through the delivery of natural regulatory proteins. As retinal gene therapy progresses to more prevalent conditions, delivering a therapeutic in a way that ensures higher consistency of dosing, whilst allowing patients to receive a less invasive treatment, is key to widespread use and clinical effectiveness. The merger ensures Gyroscope now has all the platform capabilities it requires to develop and deliver its therapeutics commercially. This marks an important step in fulfilling founding academics, David Kavanagh and Andrew Lotery’s vision of widespread use of genetically defined treatments for dry AMD.”