Sydney-based Viral Vector Manufacturing Facility (VVMF) and Melbourne-headquartered Mirugen have signed a non-exclusive Letter of Intent to evaluate and potentially develop the company's AAV-based gene therapy candidate targeting Retinitis Pigmentosa.
The genetic condition causes progressive loss of photoreceptors and vision.
Under the agreement, VVMF will run an initial pilot study to assess the productivity, recovery, and quality attributes of Mirugen’s lead candidate as the company progresses the program toward a first-in-human clinical trial.
The collaboration is designed to leverage Australia’s research and development incentives and capital-efficient clinical development environment while strengthening onshore capability in the design and manufacture of advanced therapy medicinal products.
The partners said the work will support the growth of the cell and gene therapy sector across the Asia-Pacific region and reinforce Australia’s status as an emerging hub for advanced biomanufacturing. VVMF describes itself as Australia’s only contract manufacturing organisation dedicated to viral vector research, development and manufacture for advanced therapeutic applications.
Stephen Thompson, Chief Executive Officer of VVMF, said, "Collaborating with Mirugen provides an opportunity to support the evaluation and development of promising gene therapy candidates. This Letter of Intent reflects our focus on enabling high-quality process development and manufacturing pathways for emerging therapies, while strengthening Australia’s capability in viral vector manufacturing for the global CGT market."
Charlotte Casebourne Stock, Executive Chair of Mirugen, said, "We are pleased to work with VVMF on this pilot evaluation, as Mirugen advances its lead program towards clinical development. This study will allow us to assess an emerging Australian manufacturing capability against technical criteria, while supporting the continued growth of the local gene therapy ecosystem. We are taking a staged and evidence-led approach to manufacturing and look forward to evaluating the results of this initial work."
