N4 Pharma PLC Nuvec® Research update (4926V)
09 Abril 2019 - 1:00AM
UK Regulatory
TIDMN4P
RNS Number : 4926V
N4 Pharma PLC
09 April 2019
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 ("MAR"). With the
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Service, this inside information is now considered to be in the
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09 April 2019
N4 Pharma Plc
("N4 Pharma" or the "Company")
Nuvec(R) Research update
N4 Pharma Plc (AIM: N4P), the specialist pharmaceutical company
developing Nuvec(R), a novel delivery system for vaccines and
cancer treatments, provides an update on the development of
Nuvec(R).
University of Adelaide collaboration
The Company has received the first results of its collaboration
with the University of Adelaide ("UoA"), details of which were
first announced on 02 October 2018. Under the collaboration, the
UoA has been investigating the potential of Nuvec(R) to increase
the efficacy of the UoA's novel cytolytic DNA vaccine. Initial work
on this commenced in mid-February 2019.
The initial tests were undertaken using two DNA antigens. The
first results have shown an inconsisitency in efficacy between the
in-vitro data they have generated and the results of their initial
in-vivo work. Whilst the in-vitro tests for both antigens produced
a positive response, these results were not replicated in the
initial in-vivo tests. In light of these findings, the Company will
be working with the UoA to scope a further series of experiments,
seeking to optimise the dose and administration of Nuvec(R) for use
in the in-vivo tests.
Once the UoA has been able to demonstrate a positive response in
both the in-vitro and in-vivo tests, they will be able to move to
the next phase of research, which will entail undertaking tests
with the cytolytic vaccine itself.
Further mRNA research
The Company has been undertaking in-vivo studies to investigate
responses to different doses of Nuvec(R) with the standard test
antigen, Ovalbumin ("OVA") mRNA. As announced in October 2018,
previous studies indicated that the Nuvec(R) particles have a clear
adjuvant effect to help deliver a level of response. However, in
two subsequent studies the tests have not managed to replicate
those results. Similar to the UoA study, there was an inconsistency
in efficacy between the in-vitro data and the findings of the
in-vivo studies.
Following these latest findings, the contract research
organisation which undertook the latest study has recommended a
number of options for any repeat tests. The Company's technical
team is currently assessing these proposals, together with
analysing the differences between these two recent studies and
earlier in-vivo studies to understand what may have caused the
variances.
Additional studies with other antigens are also being planned to
further investigate the properties of Nuvec(R). The results of
these tests should provide the Company with a more meaningful
understanding of the full potential of Nuvec(R).
Process improvement and move to GMP manufacture readiness
In line with the Company's process improvement plans, it has
started progressing the scale up work for the Nuvec(R) particle and
has made improvements to the manufacturing process. In particular,
the Company has been evaluating the use of lyophilisation. If
successful, it will provide a simpler scaleable process for the
manufacturing of Nuvec(R).
Next steps
Nuvec(R) has consistently demonstrated the ability to bind both
DNA and mRNA and to improve delivery in-vitro. However, in light of
the inconsistent in-vivo test results, the Company is reviewing all
the data from both in-vitro and in-vivo studies to date, to seek to
resolve the inconsistent in-vivo results. The immediate focus of
the Company will be to develop a series of experiments to determine
the reasons for these inconsistent in-vivo results. A further
update will be provided once this review is complete.
Nigel Theobald, CEO of N4 Pharma commented:
"As we begin working with new antigens, it is important to
investigate the required optimisation work to make sure that the
dose, vaccine regime and concentration of Nuvec(R) is in the
correct proportions to allow good in-vivo transfection. Each new
antigen we work with will require this before we begin in-vivo
studies. We need to ensure we can replicate the in-vitro successes
and efficacy in-vivo before moving to the next stage of each study.
Such findings are not unusual for any research and development work
and it is important to get it right before more expensive in-vivo
studies are commissioned.
"The board and its technical team are defining the experiments
to achieve these objectives as we fully digest the data to date and
expect to be in a position to set these out in the coming
weeks."
Enquiries:
N4 Pharma Plc
Nigel Theobald, CEO Via Scott PR
Allenby Capital Limited Tel: +44(0)203 328 5656
James Reeve/Asha Chotai
Scott PR
Georgia Smith Tel: +44(0)1477 539
539
About N4 Pharma
N4 Pharma is a specialist pharmaceutical company developing a
novel delivery system for vaccines and cancer treatments using its
unique silica nanoparticle delivery system called Nuvec(R).
N4 Pharma's business model is to partner with companies
developing novel antigens for vaccines and cancer treatments to use
Nuvec(R) 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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