Viral Vector Manufacturing Facility Pty Ltd (VVMF), Australia’s only commercial viral vector Contract Development and Manufacturing Organisation (CDMO) and Optosleep, an emerging startup involving researchers from UNSW Sydney, have signed a Letter of Intent (LOI) to collaborate on the evaluation and development of an adeno associated virus (AAV)-based optogenetic gene therapy program being advanced by UNSW researchers.
Under the non-exclusive LOI, VVMF will undertake an initial proof-of-concept study to assess the manufacturability of UNSW and Optosleep’s AAV9-based gene therapy candidate, a key component of the OptoSleep platform, using VVMF’s viral vector development and manufacturing capabilities. The study will evaluate productivity, recovery and quality attributes to inform manufacturing feasibility, and chemistry, manufacturing, and controls (CMC) development activities as part of a broader grant application being pursued by UNSW researchers and Optosleep.
The novel therapy candidate combines gene therapy, optogenetics and medical device technologies. The preclinical program is being developed as a potential treatment for obstructive sleep apnoea (OSA), a common disorder characterised by repeated airway collapse during sleep and affecting many people worldwide.
The approach uses an AAV-based gene therapy delivered to tongue muscles to enable light-responsive activation of upper airway muscles. In combination with a custom-fit oral appliance that delivers light pulses during sleep, the technology is intended to help maintain airway patency during sleep.
The LOI is a great example of clinical translation within the New South Wales (NSW) life sciences ecosystem, bringing together UNSW and Optosleep’s research expertise, Tyree Institute of Health Engineering (Tyree IHealthE) translational expertise, and VVMF’s advanced manufacturing capabilities. It’s a shared commitment to strengthening Australia’s sovereign capability in advanced therapy development and manufacturing while creating clearer pathways to translate promising academic research into clinical and commercial applications.
Stephen Thompson, VVMF CEO said: “Australia is producing world-class research in cell and gene therapy. Translating that research into clinical programs requires access to specialised development and manufacturing expertise that is often unavailable locally. We are excited to support the evaluation of OptoSleep’s program, supporting the development and manufacturing data needed to advance this promising therapy towards the clinic.”
Dr Ian Goon, COO Tyree IHealthE said: “This collaboration highlights the importance of bringing together the different parts of the health innovation ecosystem to address the critical translational milestones required to advance OptoSleep. We look forward to supporting its continued progression towards clinical implementation and, ultimately, improved outcomes for people living with obstructive sleep apnoea.”
Professor Lynne Bilston, School of Biomedical Engineering, UNSW Sydney, said: “We are delighted to be partnering with VVMF to develop the manufacturing approach for Optosleep’s gene therapy candidate. VVMF’s expertise in viral vector manufacturing is the essential missing piece for us to bring our new therapy to human trials and then to patients. We are excited about the potential of this partnership.