N4 Pharma makes solid progress with Nuvec programme

Specialist pharmaceutical reformulation company N4 Pharma updated the market on its ‘Nuvec’ programme on Monday, in respect of the delivery of DNA/RNA.

The AIM-traded firm described Nuvec is a “novel therapeutic nanoparticle platform” designed to deliver DNA/RNA into cells to generate proteins in situ.

Its strategy for the development of Nuvec technology would be determined by the level of immune response directed towards a protein antigen generated from the DNA/RNA loaded onto the nanoparticles, the company said.

“We are now working with contract research organisations and collaborators to generate this data which will allow us to determine the most immediate therapeutic areas which Nuvec will be most suited for,” its board explained in its statement.

On 2 February, N4 Pharma announced that it had been awarded a feasibility grant from Innovate UK to co-fund a collaboration with biologics research and development company MedImmune UK, to explore the manufacture of a prototype nanomedicine using the Nuvec system.

The company said on Monday that the collaboration had begun “well”, and the Nuvec team was making “significant progress” developing manufacturing methods for Nuvec particles loaded with therapeutic DNA/RNA encoding protein antigens.

Once completed, MedImmune would then conduct studies to demonstrate the capability of delivering such antigens to induce immune responses, the results of which were expected in the fourth quarter of 2018.

In addition to the immune response work, further research would be carried out this year to identify in which human cells Nuvec nanoparticles were most effective for transfection, as well as characterising dose and duration of response at the site of injection, including rate of breakdown and distribution in the body, N4 said.

On top of that, further work would be performed to optimise the manufacture of Nuvec nanoparticles and understand their stability in various media, which would be “informative” regarding formulation considerations, the board said.

The company expected all of the results, along with its internal immune response work, to be available in the fourth quarter which - together with the MedImmune collaboration results - would be used to form the strategy for prioritising the development of therapeutic uses of the Nuvec platform over the next year.

“I am really encouraged by the early results from the Nuvec team's experiments,” said N4 chief executive officer Nigel Theobald.

“The board believes that data generated from studies this year will result in increased understanding of the mechanism of action and potential scope of the Nuvec silica nanoparticle delivery platform enabling us to identify the development pathway for Nuvec in 2019.”

Theobald said the board’s strategy for Nuvec was similar to N4’s generics work on sildenafil - the drug most commonly known as Viagra.

“We are undertaking initial priority research to determine exactly how Nuvec behaves much like we are doing initial pharmacokinetic clinical studies for our sildenafil reformulation.

“This will allow us to focus the development of Nuvec to enable N4 Pharma to target specific licensing deals with large pharmaceutical companies.”