Grant: CCI Applied Research and Development Grants

Synthetic biology has arisen as one of the largest global industries, impacting a multitude of sectors. Within this space, global cell and gene therapy continues to surge as a leading area of growth. Continued challenges are emerging within the health space with a rise in infectious and genetic disease. Contemporary viral gene therapies continue to face many ongoing challenges with regards to safety, redosability, and versatility. A new technology, ministring DNA (msDNA), offers a novel non-viral gene therapy technology that paves the way for personalized, redosable genetic medicine that is safe, durable, and accessible for patients worldwide. Mediphage Bioceuticals located in Toronto, Canada has developed their flagship product msDNA to overcome the critical challenges facing gene therapy showing distinct advantages over current viral platforms. msDNA has proven high versatility beyond non-viral gene therapy, through high effectiveness in a range of applications, including gene editing, DNA vaccines, and as starting materials for viral vector (rAAV, LVV) and mRNA production. Internal therapeutic development may take 2-3 years before reaching the clinic. As such, there remains a need to improve production processes to satisfy the growing demand of this product as starting materials for triple transfection rAAV production has resulted in 2-4x increase in production yield and more potent final therapeutic products. In collaboration with Lambton College, Mediphage proposes to optimize the fermentation and downstream processes needed for large scale manufacturing of Mediphage’s msDNA. The results from this project will see augmented production which will lead to a scale up to a 40 L fermentation unit to conduct the growth trials while adjusting the key parameters for each run to optimize the msDNA production and selection. Mediphage will engage in Phase 2 clinical trials for multiple therapeutics in partnership with pharma companies and receive corresponding milestone payments as part of the above licensing agreements over the next 4-7 years. The optimization of msDNA production will have immense benefits not only for Mediphage but also in Canada, enhancing Canada’s reputation as a global leader in gene therapy technology. The success of this project will support and enable biomanufacturing technologies in the health sector aligning with Canada’s new direction of strengthening the biomanufacturing and life science ecosystem.