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.”
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