N4 Pharma outlines work plan after 'encouraging' data

The AIM-traded firm said the studies conducted with Nanomerics to evaluate the potential of ‘Nuvec’ as a nano-carrier of a DNA plasmid expressing TNF alpha, a cytokine with immune-modulating properties against tumours, demonstrated a significant inhibition of tumour growth derived from a human cell line.

As a result of those findings, the company said it had started work with Medicines Discovery Catapult to extend the observations, to allow it to identify suitable loads to add to Nuvec to take to the clinic.

To date, N4 said it had established that Nuvec could deliver an appropriate biological load, with the new study set to help determine the mechanism of action that produced the tumour suppression.

Among other things, it would seek to identify whether the Nuvec loaded with TNF alpha was directly taken up by the tumour cells to produce the active TNF within the tumour, or whether other organs such as the liver took up the Nuvec and produced the TNF, releasing it systemically to suppress the tumour.

If it could be demonstrated that Nuvec could “selectively deliver” the plasmid to the tumour, the firm said that could indicate the potential use of Nuvec to deliver to tumours with a reduced systemic effect, and inform the scope of any clinical studies or collaboration discussions.

In addition, studies would use labelled Nuvec particles to allow the organ and tissue distribution of Nuvec to be followed.

The company said it was also in the process of identifying alternatives to TNF as immunomodulators or gene therapy, which could use Nuvec as a delivery system.

It said that the selection process was expected to conclude “shortly”, with the firm intending to conduct a study programme similar to the work being undertaken using TNF.

All current and planned work streams were being funded from existing resources, with the board saying N4 was “well-funded” for 2022.

“We are delighted that our successful work in formulating Nuvec as a monodispersed formulation that can be freeze dried and reconstituted has opened up the opportunity for the company to use Nuvec via intravenous injection and to develop products using Nuvec as a nano-carrier of nucleotides including DNA, RNA, SiRNA with specific clinical use in oncology, gene therapy and protein replacement,” said chief executive officer Nigel Theobald.

“The oncology, gene therapy and protein replacement markets are very large and attracting significant and varied interest.”

Theobald said that, based on our current data, the markets provided the company with the quickest route to bring products into clinical trials, “far quicker” than using it for vaccines.

“With our vaccine work now continuing through MTAs, our primary focus is on these studies with Catapult and advancing our data set to a meaningful inflexion point in the coming months and I look forward to providing updates to the market in due course.”

At 1353 GMT, shares in N4 Pharma were up 7.74% at 3.34p.