Nuvec® Update

RNS Number : 0497H

N4 Pharma PLC

08 March 2018

 

N4 Pharma Plc

("N4 Pharma" or the "Company")

Nuvec® Update

N4 Pharma Plc (AIM: N4P), the specialist pharmaceutical company which reformulates existing drugs and vaccines to improve their performance, is pleased to provide an update on its Nuvec® program in respect of the delivery of novel and existing vaccines.

Whilst the Company awaits the imminent commencement of pilot human trials for its reformulation of sildenafil, the Directors have been developing a work plan for the Company's proprietary Nuvec® technology. Nuvec® is a nanosilica system which targets the delivery of therapeutics such as RNA, DNA, vaccines and targeted cancer therapies and is being positioned as a potential alternative delivery system to lipid nanoparticles and lipid nanosomes.

Appointment of Head of Nuvec® Development

The Company is delighted to announce the appointment of Andrew Leishman as Head of Nuvec® Development. Having previously worked at Astra Zeneca as a Senior Research Scientist, Andrew brings with him a wealth of research and development expertise to the Company's lead vaccine delivery program. Andrew has worked on a variety of clinical and pre-clinical assets across respiratory, inflammation and oncology for several pharmaceutical companies.

Development Strategy for Nuvec®

The development strategy for Nuvec® is two-fold. Firstly, the Company is proactively looking to work with partners to evaluate its Nuvec® system with their products. Recently, N4 Pharma announced a partnership with MedImmuneUK and is looking to add additional partnerships in due course. The Company's recent trip to Japan was successful in providing useful introductions to potential partners which will be progressed over the coming months. The Company will also be attending Bio-Europe Spring, an international partnering conference in Amsterdam, from 12 - 14 March 2018. Secondly, the Company has embarked on an internal research programmeto expand the dataset required in order to advance Nuvec® towards commercialisation.

Over the coming months, the Company proposes to carry out the following work on Nuvec®:

·     Demonstrate human primary cell transfection, crucial to understand the mechanism of action;

·     Investigate the degree of nuclease protection achieved;

·     Demonstrate pre-clincialefficacy; and

·     Undertake a pre-clinical toxicology study to further understand the impact on the body of Nuvec® particles following subcutaneous administration.

The Company's strategy allows it to determine precisely how Nuvec® will be used by its partners, either as a vaccine, a delivery system for therapeutics, or both. The first phase of work is well underway and the Company has demonstrated the ability to dose-dependently transfect a range of cells and is now looking to determine which primary cells are crucial in that process. The next phase is to focus on CMC charecterisation of Nuvec® and to undertake pre-clinical PK, pharmacology, and toxicology work. All of these elements are criticial to allow Nuvec® to ultimately enter into human clinical trials with a partner. The Company expects to complete much of this work by the end of 2018. The Company will then look to start working with a CMO to generate GMP batches of Nuvec® to support clinical trials, which will be its main focus in 2019.

Market research report identifies $178 billion market

The Company recently commissioned a market research report from Agility Health Tech to assess the potential market position for Nuvec®. Whilst there are currently no approved products which use nanosilica as a drug delivery vehicle, the total market size for nanotechnology drug delivery was valued at $79 billion in 2012 and is expected to reach a value of $178 billion in 2019, representing a compound annual growth rate of 4.15% (further details below).

Nigel Theobald, CEO of N4 Pharma, commented: "I am very excited about the potential for Nuvec® and the appointment of Andrew to the team. I have no doubt that he will be a valuable asset to the business. The additional funds received from the recent warrant exercises put us in a strong position and not wholly reliant on partnerships to generate data for Nuvec®, thereby making it easier for us to enter other commercial discussions. We will continue to discuss partnerships and seek relevant grant funding, where appropriate, to minimise our outgoing expenditure.

Our intention is to undertake the relevant research and pre-clinical work to allow Nuvec® to be in a position to enter human clinical studies with a partner by the end of 2020."

Enquiries:

N4 PharmaPlc Nigel Theobald, CEO	Via Alma PR
Stockdale Securities Tom Griffiths	Tel: [phone]
Alma PR Josh Royston Robyn Fisher	Tel: [phone] Tel: [phone]

About N4 Pharma

N4 Pharma is a specialist pharmaceutical company which reformulates existing drugs and vaccines to improve their performance.

N4 Pharma's reformulation work falls under two divisions:

• generic, already commercialised, drugs; and

• delivery of novel and existing vaccines.

N4 Pharma has identified a number of established drugs that could be improved upon through its reformulation techniques. N4 Pharma's most advanced reformulation is for sildenafil, widely marketed as Viagra, where N4 Pharma is seeking to improve the speed at which the drug takes effect whilst also extending its duration of action.

N4 Pharma's reformulation approach should take approximately three years to obtain regulatory approval as opposed to the traditional process for new drugs of on average ten years. The cost and risk profile of this model is also significantly less than the traditional process. N4 Pharma's business model for generics is to take reformulated drugs from its portfolio through to the stage where it will license its newly reformulated drugs to pharmaceutical companies to commercialise them. N4 Pharma's revenues should be derived from up front milestone and royalty payments associated with the licence.

N4 Pharma's business model for vaccines is to undertake the required clinical work to demonstrate the capability of its delivery system as a cancer vaccine or therapeutic treatment so that it can license the technology to major players developing treatments in this area, again in return for up front milestone and royalty payments associated with the licence.

Glossary:

"CMC"	Chemistry, Manufacturing and Controls
"CMO"	Contract Manufacturing Organisation
"GMP"	Good Manufacturing Practice
"PK"	Pharmacokinetic

Agility Health Tech Report:

The market is split into 10 categories:

Nanotechnology	Market Percentage	Market Size in 2019, US $
Liposomes	22.0%	$39.2bn
Nanocrystals & non-metal nanoparticles	18.6%	$33.2bn
PEGylatednanoformulations	15.3%	$27.2bn
Metal-based nanoformulations	10.2%	$18.1bn
Polymer-based nanoformulations	10.2%	$18.1bn
Surfactant-based nanoformulations	6.8%	$12.1bn
Lipid-based non-liposomal formulations	5.1%	$9.1bn
Protein-drug conjugates	5.1%	$9.1bn
Multiparticulates	3.4%	$6.0bn
Virosomes	3.4%	$6.0bn

Company Research:

The Company's latest research has identified the following technical highlights:

·    Identified DNA and RNA loading capacities of particles, with nuclease protection studies ongoing

·    Transfection using DNA loaded particles confirmed in human and mouse cancer cell lines, with similar studies assessing RNA transfection ongoing

·    Identfied maximum tolerated concentrations for particles across cell lines and primary cells, and shown induction of inflammatory cytokines only occurs at toxic concentrations

·    Demonstrated dose-dependent transfection with DNA loaded particles in-vivo using doses which do not induce high levels of systemic inflammatory cytokines

 

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