REG - N4 Pharma PLC - Operational Update

N4 PharmaAnnouncement

13/12/2021 07:00

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RNS Number : 3469V  N4 Pharma PLC  13 December 2021

13 December 2021

N4 Pharma Plc

("N4 Pharma" or the "Company")

Operational 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 a strategic update following data from its proof-of-concept
programmes and ongoing activities.

As announced previously, the Company has spent the last few months conducting
various in vivo studies both in oncology and vaccine delivery. In parallel,
work has continued with third party collaborators under Material Transfer
Agreements ("MTAs").

Oncology programme

The Company has successfully completed an in vivo confirmatory oncology study
which reinforces the results from an earlier pilot study. The initial pilot
study was designed to test the ability to use a monodispersed Nuvec®
formulation in an intra venous ("i.v") route of administration using a DNA
plasmid (pDNA) encoding TNF alpha to assess the tolerance of different doses
and to look at tumour regression.

The confirmatory study incorporated the following control and test groups: TNF
alpha pDNA alone, unloaded Nuvec®, Nuvec® loaded with 50ug of the TNF alpha
pDNA and Nuvec® loaded with 20ug of TNF alpha pDNA.  The study was conducted
in untreated tumour-bearing mouse models with dosing for each cohort completed
intravenously.

The results showed a clear inhibition of tumour progression for the groups
where Nuvec® was loaded with TNF alpha pDNA when compared to the other three
groups. In addition, the use of Nuvec® was shown to improve animal survival
rates in the life of the study.

These excellent findings show that injection of a TNF alpha plasmid loaded
onto Nuvec® into tumour bearing mice successfully leads to the transfection
and release of TNF alpha which results in the suppression of tumour growth and
increased survival rates.

The results from the successful oncology study are an exciting finding and
opens up the field of gene therapy and in vivo protein production as a key
opportunity for Nuvec®. This will become an important area of focus moving
forward. This advancement is the result of the ongoing optimisation work to
produce a consistently monodispersed product, presenting potentially huge
market opportunities for Nuvec®.

In vivo studies for vaccine delivery

The preliminary results from mouse immunogenicity studies carried out by
Evotec using Covid-19 plasmid DNAs and other controls have not shown
meaningful immunological response despite good in vitro antigen expression.
Lack of immunological response in positive control animals brings into
question the validity of the whole study. Nevertheless these results again
highlight that a number of variables such as dose, route of administration,
timing of injection and formulation require extensive optimisation for each
plasmid loaded onto Nuvec®. Likewise, the Company's initial mRNA OVA in vivo
immunogenicity study showed sub optimal responses. As a result, the Company
has taken the decision to concentrate future vaccine work through its MTAs
with a focus on specific products linked to proprietary DNA or mRNA sequences.

This strategy is validated by the fact that the Company is in advanced
discussions with another company focussing on mRNA delivery with a view to
scoping the work to be undertaken under a new MTA. This is in addition to the
two ongoing MTAs signed looking at Nuvec® with proprietary Covid 19 DNA
plasmids and gene therapy.

Aside from the in vivo work, The Medicines Catapult has recently assessed, in
vitro, Nuvec® loaded with DNA that had been stored at room temperature for
six months. Cell transfection was successful demonstrating the stability of
the Nuvec® loaded with DNA and the potential storage advantages of Nuvec.
Thus, it has been shown that both mRNA and DNA loaded on Nuvec® are conferred
a high level of stability which may be an important feature in the MTA related
studies.

Next Steps

Taking into account the recent data and very positive oncology work, the
Company has strategically decided to focus its resources on advancing its work
in gene therapy whilst continuing its vaccine delivery efforts in conjunction
with partners working with specific, proprietary products. Once the full
analysis is complete on the oncology study, the Company will scope out the
next study in this area to commence early in the new year with a view to
demonstrating a clinically relevant therapeutic effect with a targeted end
point that will enable the Company to enter commercial discussions in this
area.

Nigel Theobald, Chief Executive Officer of the Company, commented: "We are
delighted with the results from our more expansive oncology study repeating
and validating the earlier results from our pilot. Having successfully
formulated a monodispersed version of Nuvec®, this has allowed the Company to
determine the most attractive way for it to commercialise Nuvec®.

"Whilst the results on the vaccine work from Evotec were unexpected, the
proof-of-concept data, that we have collated to date, has been sufficient to
allow the Company to sign MTAs with potential vaccine collaborators.  We
expect other collaborations will follow, so it makes sense to continue the
vaccine platform optimisation with collaborators who own their own DNA
plasmids and mRNA compounds. This will allow us to focus internal efforts on
developing commercial products in the gene therapy space.

"The Company remains well funded to complete the next phase of its gene
therapy product development which we believe will give it the greatest chance
to negotiate partnerships in this space with a range of different companies.

"I believe this evolved strategy gives us the best opportunity to grow the
Company into a successful and sustainable life sciences business."

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.  Upon the publication of this announcement via
Regulatory Information Service, this inside information is now considered to
be in the public domain.

Enquiries:

 N4 Pharma Plc                                       Via IFC Advisory

 Nigel Theobald, CEO

 Luke Cairns, Executive Director

 SP Angel Corporate Finance LLP                      Tel: +44 (0)20 3470 0470

 Nominated Adviser and Joint Broker

 Matthew Johnson/Caroline Rowe (Corporate Finance)

 Vadim Alexandre/Rob Rees (Corporate Broking)

 Turner Pope Investments (TPI) Limited               Tel: +44 (0)20 3657 0050

 Joint Broker

 Andy Thacker

 IFC Advisory Limited                                Tel: +44 (0)20 3934 6630

 Financial PR

 Graham Herring

 Zach Cohen

 

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.

 

 

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