Manufacturing process development for Nuvec nanoparticles for the delivery of therapeutic Papilloma Virus (HPV) nucleic acid vaccines

"Human Papilloma Virus (HPV) has been implicated in a range of cancers. Currently, a prophylactic vaccine is prescribed for adolescent girls with a view to prevent infection by HPV. However, this preventative vaccine does not have a therapeutic effect on malignancies developed as a result of HPV infection. In this regard, the use of nucleic acid vaccines for treatment of HPV related cancers has been considered, for which the proposed strategy is to induce antigen specific immune response to cancer cells in the body. As for many systems of this type the challenge is to deliver the plasmid DNA (pDNA) or messenger RNA (mRNA) effectively to antigen presenting cells, with a view to stimulating recognition and destruction of cancerous cells by the immune system. The challenge for pDNA vaccine delivery relates to the availability of suitable and safe non-viral vectors which have high loading capacity for pDNA and mRNA and are able to recruit antigen presenting cells to the site of injection, but do not elicit an excessive inflammatory response.

In this regard, N4 Pharma have developed a novel vector (Nuvec), which has been demonstrated to provide high nucleic acid loading capacity and transfection in in-vitro and in-vivo experiments. This 9 month feasibility project will explore the manufacture of a prototype nanomedicine product using N4 Pharma's Nuvec system for delivery of a therapeutic HPV nucleic acid vaccine. It will focus on the design of a process for manufacturing Nuvec nanoparticles optimally loaded with pDNA and modified mRNA encoding antigens specific to HPV related malignancies. This will include evaluation of strategies for maximising loadings and reducing the levels of free nucleic acids in the formulation."