N4 Pharma Plc Regulatory News (N4P)

02 October 2018

N4 Pharma Plc

("N4 Pharma" or the "Company")

Research collaboration for novel DNA vaccine

N4 Pharma Plc (AIM: N4P), the specialist pharmaceutical company developing silica nanoparticles for vaccines and therapeutics, today announces that it has commissioned a research program with the Gowans laboratory in the University of Adelaide ("UoA") to investigate the potential of the Company's Nuvec® system to increase the efficacy of UoA's novel DNA vaccine.

The UoA has developed a novel cytolytic DNA vaccine which encodes an immunogen and a cytolytic protein (perforin). UoA has shown their cytolytic DNA vaccine to be significantly more immunogenic than a canonical DNA vaccine (which encodes an alternative immunogen) when delivered via the intradermal route. DNA vaccines are being developed as novel vaccine strategies to improve on the poor immunogenicity seen by traditional protein based vaccines in cancer and infection (e.g. HIV, hepatitis C).

Despite UoA showing improved immunogenicity with their cytolytic DNA vaccine the immune response is not sufficient to proceed into clinical trials. The purpose of this research collaboration is to determine if the use of Nuvec® can further increase the efficacy of the UoA cytolytic DNA vaccine in vivo.

The research program will not result in any financial benefit to the Company and the limited costs of the research, which are not expected to exceed £30,000, will be borne by N4 Pharma. Phase 1 is to test the delivery efficacy of combining the UoA cytolytic DNA vaccine with Nuvec® and will take around 4 weeks before proceeding into actual immunogenicity studies using different models, which would take a further 24 weeks.

Nigel Theobald, CEO of N4 Pharma commented: 

"This research program is a good example of how we see Nuvec® ultimately being used by partners. UoA has developed a novel cytolytic DNA vaccine but still needs to enhance its efficacy in order to take it forward.

"By partnering with UoA in this way and funding this research N4 will gain considerable insight into Nuvec's enhancing capability which will then form part of the data package to present to prospective commercial partners."

Enquiries:

About N4 Pharma

N4 Pharma is a specialist pharmaceutical company developing a novel silica nanoparticle delivery system (Nuvec®) for use in vaccines and therapeutics.

Nuvec® has a unique spiky structure designed for excellent loading and transfection of pDNA and mRNA. As well as good dose loading it has strong binding affinity, pDNA and mRNA protection, transfects a range of cells and has shown a good immune response in preliminary studies.

N4 Pharma's business model for Nuvec® nanoparticles is to undertake the required pre-clinical and manufacturing work to demonstrate the readiness and capability of its nucleic acid delivery system as part of a vaccine and/or method to deliver DNA/RNA so that it can license the technology to major players developing treatments in this area, in return for up front milestone and royalty payments associated with the licence.

Glossary

Cytolytic: An agent that causes a cell to burst open. In the context of the cytolytic DNA vaccine, the cytolytic protein will induce necrosis in vaccine targeted cells resulting in release of a range of damage associated molecular patterns (DAMPs) and cross presentation of the immunogen (antigen), and an increase in antigen-specific immune responses.

Canonical DNA vaccine: DNA encodes the immunogen only (i.e. not the cytolytic agent). DNA vaccines not encoding a cytolytic agent, such as perforin, fail to result in cell death and rely on direct targeting of antigen presenting cells. Hence, canonical DNA vaccination is less efficient than cytolytic DNA vaccination.