A unique non-viral adjuvant delivery system for vaccines and cancer treatments. This silica nanoparticle has the potential to help commercialise cancer immunotherapy drugs and improve the effectiveness of viral vaccines.

Nuvec® silica nanoparticles have a unique irregular (spikey) surface structure, coupled with polyethyleneimine (PEI), that simply and effectively traps and protects nucleic acid (such as mRNA / pDNA) as it travels to the cells. Once inside the cell, it is released to activate the immune system. Nuvec® is also a natural adjuvant so it attracts large numbers of antigen presenting cells which, in turn, leads to a strong activation of T-cells, increasing the level of immune response against the target cancer cells.

Studies so far have shown that Nuvec® is well tolerated, even at high doses, with no major toxicology findings across rat/mouse in vivo and PBMC/spleen in vitro studies. Nuvec® has been shown to remain at the injection site, without being directed to the liver, unlike some lipid systems, which can result in systemic inflammation. Nuvec® has been developed with a scalable manufacturing process, using standard processing technology.

Recent studies have confirmed that the immune response observed with Nuvec® was sufficient to have produced high levels of antibodies specific for the standard test antigen Ovalbumin (OVA).  A high level of antibody production is essential for a vaccine to initiate immunity. The levels of antibodies produced were greater than those of in vivo-jetPEI®, an industry standard used to deliver pDNA-OVA in pre-clinical studies. Furthermore, assessing the produced antibody isotypes, it became evident that Nuvec® delivers a robust immune response necessary for an effective vaccine in the field of oncology and virology.

Dr Allan Hey, Head of Nuvec® CMC Program Development commented: “Existing delivery systems, such as lipid nanoparticles, were not originally designed for working with nucleic acids and although they can also produce good immune responses, they can be unstable and difficult to handle and often require an additional adjuvant / immunomodulator to ensure immunogenicity. They can also cause liver toxicity. Nuvec® has been designed specifically to work with nucleic acids, which are the subject of significant research investment in the fields of cancer immunotherapy and vaccines.

N4 Pharma was established in 2014 by Nigel Theobald, previously head of healthcare brands at Boots Group plc and founder of a series of successful businesses, including Oxford Pharmascience Group plc. Joining Nigel on N4 Pharma’s Board are Paul Titley, who offers 40 years’ experience in the pharma industry, Dr David Templeton, pharmacology and pre-clinical drug discovery expert and Luke Cairns, Corporate Financier. N4 Pharma added to its R&D team in 2018 with the appointments of Dr Allan Hey as Head of Nuvec® CMC Program Development and Dr Melody Janssen as a Consultant for the Nuvec® biological research program. N4 Pharma floated on the AIM stock market in May 2017.

Nigel Theobald added: “The more research we undertake with Nuvec®, the more potential we uncover. Many indications are pointing towards it being a more effective delivery particle than current alternatives for DNA and mRNA, particularly in cancer immunotherapy and viral vaccines. We are now undertaking further essential pre-clinical research, focussing on demonstrating actual immune efficacy of the particles in combination with an alternative tool antigen, as well as OVA. Our goal is to have Nuvec® ready to be used in clinical trials in 2020 and all indications so far are that this is entirely achievable.