N4 Pharma Plc Regulatory News (N4P)

25 January 2022

N4 Pharma Plc

("N4 Pharma" or the "Company")

Oncology work programme update

N4 Pharma Plc (AIM: N4P), the specialist pharmaceutical company developing Nuvec®, a novel delivery system for cancer treatments and vaccines, is pleased to provide details of its work plan following the encouraging data from its oncology research as announced on 13 December 2021.

The Board is delighted that the studies conducted with Nanomerics to evaluate the potential of Nuvec® as a nano-carrier of a DNA plasmid expressing TNFalpha ("TNF"), 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 these positive findings, the Company has commenced work with Medicines Discovery Catapult* ("Catapult") to extend the observations to allow it to identify suitable loads to add to Nuvec® to take to clinic. To date, the Company has established that Nuvec® can deliver an appropriate biological load and this new study will help determine the mechanism of action that produced the tumor suppression. Amongst other things, it will 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 and released it systemically to suppress the tumour. If it can be demonstrated that Nuvec® can selectively deliver the plasmid to the tumour this may 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 will use labelled Nuvec® particles to allow the organ and tissue distribution of Nuvec® to be followed. 

The Company is also in the process of identifying alternatives to TNF as immunomodulators or gene therapy which may use Nuvec® as a delivery system. The selection process is expected to conclude shortly and the Company intends to conduct a study programme similar to the work being undertaken using TNF.

All current and planned work streams are to be funded from existing resources and the Company remains well funded for 2022.

Nigel Theobald, Chief Executive Officer of the Company, commented: "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.

"The oncology, gene therapy and protein replacement markets are very large and attracting significant and varied interest. Based on our current data, these markets provide 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."

*The Medicines Discovery Catapult is a government funded, not-for-profit organisation established by Innovate UK to support UK innovation. The Catapult Network brings together nine leading technology and innovation centres spanning over 40 locations across the UK. Catapults are physical centres with cutting-edge R&D infrastructures including hubs, laboratories, testbeds, factories and offices, as well as technical experts that prove and adopt breakthrough products, processes, services and technologies.

Catapults work with thousands of innovative businesses across a wide range of sectors, such as manufacturing, space, health, digital, energy, transport, telecoms, the urban environment and many others to help industry get high potential ideas to market - fuelling business growth, and increasing productivity. 

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 which has been incorporated into UK law by the European Union (Withdrawal) Act 2018.

Enquiries:

About N4 Pharma

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

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