N4 Pharma PLC Nuvec® Research update (1236W)
15 Abril 2019 - 1:00AM
UK Regulatory
TIDMN4P
RNS Number : 1236W
N4 Pharma PLC
15 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
publication of this announcement via a Regulatory Information
Service, this inside information is now considered to be in the
public domain.
15 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).
Further to the announcement of 9 April 2019, disclosing
inconsistencies in the efficacy of Nuvec(R) between various in
vitro and in vivo studies, the Company is pleased to provide an
update in light of the subsequent data review to determine
appropriate next experiments, the aims of which are to resolve the
inconsistencies and demonstrate repeatable in vivo data.
In reviewing the work done by collaborators and contract
research organisations ("CROs") engaged by the Company, it has
become clear that not only were there a number of variables between
the studies (as determined by the collaborator or CRO) such as
dosage, injection volume and source of antigen, but also the
handling and preparation of Nuvec(R) may have differed materially
from the original protocols used by the University of Queensland
("UQ") and developed by N4 Pharma.
With Nuvec(R) originating out of UQ and the original in vivo
success having been achieved there, the Directors have decided
that, in order to maximise the chances of success for future or
repeat studies, the original data transfer reflecting UQ's
successes needs to be more clearly documented. This will assist
collaborators and CROs with their subsequent work. To that end, the
Company will commission UQ to repeat its original studies to
demonstrate repeated strong antibody response with the standard
test antigen Ovalbumin ("OVA") and, in doing so, document clearly
the preparation steps for Nuvec(R) prior to injection. In addition,
the Company will expand the study to include further variables to
strengthen the depth of data to emerge from this work. This study
at UQ is expected to then provide a validated testbed against which
future enhancements can be benchmarked.
It is expected that once this work commences it will take three
to four months to conclude and for the results to be documented. In
the meantime, the Directors are actively reviewing all other work
streams to put on hold any other non-essential studies not already
commenced. As outlined above, the Directors believe that by
reverting to the original source of Nuvec(R) and more clearly
defining UQ's usage of Nuvec(R), it will greatly enhance the
potential for success and understanding of comparable studies
moving forward.
Nigel Theobald, CEO of N4 Pharma commented:
"In reviewing our various data sets and talking to our partners,
it has become clear that the most expeditous route to progressing
Nuvec(R) is to revert to source and the work of UQ. The team at UQ
know Nuvec(R) better than anyone and we feel confident that a
positive repeat study, clearly documented with respect to
methodology, will greatly aid other CROs in their studies. Whist it
is a disappointing decision to put other work on hold, doing so
keeps the Company well funded to do our future planned work once we
have a better documented handling and preparation protocol from
UQ."
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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