Viral Vector Manufacturing Facility Pty Ltd (VVMF) and Mirugen Pty Ltd have signed a Letter of Intent (LoI) to collaborate on the evaluation and potential development of an adeno-associated virus (AAV)-based gene therapy candidate, in a move the companies say will support Australia’s advanced therapy manufacturing capabilities.
According to a media release from VVMF, the non-exclusive agreement will see VVMF conduct an initial pilot study to assess the productivity, recovery and quality attributes of Mirugen’s lead gene therapy candidate, which is being developed to treat Retinitis Pigmentosa, an inherited condition that causes progressive degeneration of photoreceptors and vision loss.
The companies said the collaboration reflects a shared commitment to advancing gene therapy innovation while strengthening Australia’s onshore capabilities in the development and manufacture of advanced therapy medicinal products (ATMPs).
VVMF said Mirugen’s lead program is progressing towards a first-in-human clinical trial and could benefit from Australia’s clinical development environment, including research and development tax incentive frameworks. The companies also said the collaboration supports the continued growth of the cell and gene therapy sector across the Asia-Pacific region and reinforces Australia’s position as an emerging advanced biomanufacturing hub.
VVMF chief executive officer Stephen Thompson said the collaboration aligns with the company’s focus on supporting emerging therapies through manufacturing expertise.
“Collaborating with Mirugen provides an opportunity to support the evaluation and development of promising gene therapy candidates,” Thompson said.
“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.”
Mirugen executive chair Charlotte Casebourne Stock said the pilot study would help assess Australia’s emerging manufacturing capabilities as the company advances its lead program.
“We are pleased to work with VVMF on this pilot evaluation, as Mirugen advances its lead program towards clinical development,” Casebourne Stock said.
“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.”
According to VVMF, ATMPs are therapies based on genes, cells or tissue engineering that require specialised manufacturing expertise and infrastructure due to their complexity. The company said viral vectors are a key component in delivering genetic material into cells and are used in the development of treatments for cancers, rare diseases and other advanced therapeutic applications.
VVMF describes itself as Australia’s only contract development and manufacturing organisation dedicated to the research, design, development and manufacture of viral vectors for advanced therapeutic applications, while Mirugen is a preclinical biotechnology company developing regenerative therapies for retinal diseases.
