N4 Pharma Plc Regulatory News (N4P)

29 October 2018

N4 Pharma Plc

("N4 Pharma" or the "Company")

Nuvec® research update

N4 Pharma Plc (AIM: N4P), the specialist pharmaceutical company developing a novel delivery system for vaccines and cancer treatments, today announces an update on the latest key research findings for the Company's Nuvec® delivery system.

As announced on 18 June 2018, the Company has been undertaking a key research study to determine the level of immune response Nuvec® can deliver when combined with a target antigen. This study has been undertaken using both messenger RNA ("mRNA") and plasmid DNA ("pDNA")  encoded with the standard test antigen Ovalbumin ("OVA"). The work has been performed both by N4 Pharma and as part of the Company's grant collaboaration with MedImmune UK, announced on 2 February 2018.

The results demonstrate that the Nuvec® particles themselves have a clear adjuvant effect to help deliver a level of immune response for both the mRNA and pDNA OVA antigens comparable to that of existing delivery systems. The fact that Nuvec® provides such an adjuvant response directly means an additional adjuvant would not be required when formulating a vaccine using Nuvec® as the delivery system. This would simplify and reduce the production cost of the final vaccine and mean less antigen would be required. Furthermore, the level of immune response is generated using a dose of Nuvec® particles that is within acceptable levels showing no adverse toxicity.

The data received to date indicates that Nuvec® will be suitable for use with multiple antigens. Following this, the Company has now shown successful loading and delivery of mRNA as well as pDNA and now have both in vitro and in vivo data to show that Nuvec® not only delivers the mRNA and pDNA intracellularly, it does so to a sufficient level to generate a required immune response.

Additional studies to optimise the loading properties of Nuvec® and to characterise the immune response are in progress. The Company will provide further updates following the conclusion of these studies.

Nigel Theobald, CEO of N4 Pharma commented: 

"These results are another positive step forward for our Nuvec® delivery platform. The data validates the potential of Nuvec® to act as an alternative delivery system for the development of vaccines and cancer treatments but without the associated unwanted systemic side effects and with no signs of liver toxicity often seen using lipid nanoparticle systems.

"Our next research study will focus on demonstrating the ability of Nuvec® to deliver an effective level of immunity using OVA, results of which will be available in first half of 2019.

"We are pleased with the Nuvec® results received to date and will continue to focus on the many opportunities that we believe will exist for Nuvec® to be used to develop a range of different vaccines and cancer treatments. We are building a compelling data package to aide our commercial collaboaration discussions which we continue to progress."

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About N4 Pharma

N4 Pharma is a specialist pharmaceutical company developing a novel delivery system for vaccines and cancer treatments using its unique silica nanoparticle delivery system called Nuvec®

Nuvec® has shown to be capable of loading and delivering mRNA and pDNA into cells to the required level needed to generate an immune response. Further work will be undertaken for the direct loading and delivery of peptides and proteins using Nuvec®.

N4 Pharma's business model is to partner with companies developing novel antigens for vaccines and cancer treatments to use Nuvec® as the delivery vehicle to get their antigen into cells to express the protein needed for the required immune response. As these products progress through pre clinical and clinical programs N4 will receive up front and milestone payments and ultimately royalty payments once products reach the market.

Glossary:

Adjuvant: An immunological agent that is used in vaccines to help boost the immune response to produce more antibodies for longer lasting immunity.