Nuvec, which delivers DNA directly into cells in a bid to encourage the production of anti-cancer antigens, has been accepted by the European Nanomedicine Characterisation Laboratory (EUNCL) to undertake a full characterisation programme.
The aim of the EUNCL’s characterisation programme is to accelerate nanomaterials’ development towards regulatory approval by the European Medicines Agency (EMA).
Importantly, the EUNCL is funded by the EU’s Horizon 2020 programme, significantly reducing the cost of N4 Pharma’s regulatory development programme.
“The acceptance by EUNCL onto this programme is a huge step in the right direction for our Nuvec development plans,” said chief executive Nigel Theobald.
“The programme will provide us with direct access to leading nanomaterial experts across Europe to allow us to do a full regulatory assessment of Nuvec and provide invaluable information to our potential collaboration partners.
“The acceptance by EUNCL is a strong indication of the exciting potential for our Nuvec system and as the costs of these studies will be met within the EUNCL grant, it significantly reduces the cost to the company of our regulatory development programme.”
Bad few months for N4
It comes after a difficult few months for N4, which was forced to scrap its generic drugs business last week following the failure of its Viagra reformulation in an early-stage clinical trial.
At the time, the company said the results from the sildenafil study meant it was unlikely that its two other generic reformulations would be successful.
Shares rose 22% to 4.9p on Monday morning.