TIDMN4P
RNS Number : 5502J
N4 Pharma PLC
20 August 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. Upon the
publication of this announcement via Regulatory Information
Service, this inside information is now considered to be in the
public domain
20 August 2019
N4 Pharma Plc
("N4 Pharma" or the "Company")
Results of University of Queensland Study
N4 Pharma Plc (AIM: N4P), the specialist pharmaceutical company
developing Nuvec(R), a novel delivery system for vaccines and
cancer treatments, is pleased to announce the results of the recent
repeat in vivo study by the University of Queensland ("UQ") to
investigate the use of a reference standard plasmid DNA expressing
Ovalbumin ("pDNA OVA"), details of which were announced on 15 April
2019.
Highlights
-- Successful repeat of the pDNA OVA study demonstrates that
Nuvec(R) is capable of working in vivo when using multiple
injections at certain doses
-- Together with previously acquired data, these results also
confirm that Nuvec(R) under the appropriate conditions can promote
transfection using both DNA and RNA
-- N4 Pharma will now focus on improving the Nuvec(R) loading
process to increase the consistency of the in vivo results, which,
once successful, will allow the Company to move from exploratory
collaborations to engage in full licensing discussions
-- The Company remains well funded to do this next work
Background to study
The objective of this repeat non-clinical study was: to
reconfirm that Nuvec(R) was capable of generating an effective pDNA
OVA antibody response; to extend the Company's knowledge of the
factors involved in ensuring a robust and consistent response; and
to affirm the precise loading protocol and methodology, in order to
properly document the process for successful technology transfer to
other contract research organisations ("CROs") and partners.
The study was undertaken by scientists at UQ, who are experts in
the field of silica nanoparticles and from whom the Company
obtained the licence to develop Nuvec(R). The study was conducted
using UQ's protocol for loading DNA onto Nuvec(R) with different
DNA:Nuvec(R) ratios, to try to determine the optimum ratio. In this
study, the pDNA was tested at ratios of 50ugDNA/500ugNuvec(R)
(1:10), 50ugDNA/1000ugNuvec(R) (1:20) and 50ugDNA/1500ugNuvec(R)
(1:30). The ratio is a measure of the number of DNA plasmids bound
to Nuvec(R). At the lower ratio (1:10) more plasmids are attached
to each Nuvec(R) nanoparticle relative to the higher ratio, but the
total DNA that is injected is constant.
In addition, a separate part of the study evaluated the number
of injections (one, two or three) at weekly intervals required to
obtain a response. The primary response that was being sought was
the presence of antibodies to the foreign protein OVA in the murine
blood. The level (titre) of antibodies was measured using a
standard ELISA methodology.
Results of study
The Company is pleased to announce that analysis of its pDNA OVA
findings has again demonstrated that, after three injections,
Nuvec(R) produces an immune response capable of delivering a very
clear increase in the number of antibodies specific for OVA in the
1:20 and 1:30 doses, where all test cases (6/6) responded. However,
there was only a small response at the 1:10 ratio in 50 per cent.
(3/6) of the cases tested.
The evaluation of the response after two injections was
compromised by the design of the experiment, where blood samples
were taken too soon after the second injection. However, the
results did indicate a trend towards the appearance of OVA
antibodies in these tests as well.
Analysis after a single injection at a ratio of 1:30 showed a
negligible response where only one case responded (1/6). This is in
line with previous studies undertaken outside of UQ, where
inconsistent results had been observed when the CRO had only used
one injection in its study.
These results clearly demonstrate that, under the appropriate
conditions and with multiple injections, Nuvec(R) can promote
transfection by plasmid DNA and lead to the production of the
relevant circulating antibody. Together with previously acquired
data, these results also confirm that Nuvec(R) under the
appropriate conditions can promote transfection using both DNA and
RNA.
Next steps
The next steps for the Company will be to improve the process
involved in loading DNA onto the particle to establish whether
improving dispersion will result in greater in vivo consistency.
This is seen by the Directors of N4 Pharma as the key step to
enable the Company to open commercial licensing discussions in
respect of Nuvec(R).
To that end, the Company has undertaken a technical review of
the processes employed in the manufacture and loading of Nuvec(R)
and has identified steps which require further investigation and
refinement to ensure that a highly monodisperse product is
consistently produced. A program of CMC and pre-clinical studies
has been identified which will culminate in further in vivo testing
of the improved Nuvec(R) nanoparticle in vaccine and oncology
efficacy models. It is anticipated that this program of work will
extend over the next 12 months.
Nigel Theobald, CEO commented:
"The successful repeat of the pDNA OVA study at UQ demonstrates
that Nuvec(R) is capable of working in vivo when using multiple
injections at certain doses.
"We can now focus on improving the Nuvec(R) loading process to
increase the consistency of the in vivo results, which, once
successful, will allow us to move from exploratory collaborations
to engage in full licensing discussions. We will be in a much
stronger position for these discussions once this work has been
successfully concluded. The Company remains well funded to do this
next work.
"In parallel to this, we continue to evaluate potential
acquisitions and/or investments to diversify the Company's asset
base whilst this work on Nuvec(R) remains ongoing."
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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END
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