TIDMIMM
RNS Number : 7362S
Immupharma PLC
18 November 2021
RNS | 18 NOVEMBER 2021
ImmuPharma PLC
("ImmuPharma" or the "Company")
CORPORATE UPDATE
The Evolution of ImmuPharma
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and
development company, is pleased to present a comprehensive and
detailed update of the significant positive progress achieved since
major changes in the Board and Senior Management re-structuring in
August 2021.
Key highlights
-- Lupuzor(TM) PK study on track to deliver results in Q1 2022
and to move into Phase 3 thereafter
-- P140/Lupuzor(TM): new proprietary synthesis of P140 giving
greater IP protection and cost efficiencies
-- P140-CIDP moving into a Phase 2/3 adaptive registration
clinical trial in 2022 with anticipated 'orphan drug' designation.
Commercial partnering discussions ongoing
-- Professor Sylviane Muller & CNRS relationship strengthened to exploit P140 opportunities
-- BioAMB: Excellent results from pre-clinical study, with
further significant updates anticipated in H1 2022. Commercial
partnering discussions ongoing
Introduction
Shortly after the Board and Senior Management re-structuring in
August 2021, we published a Corporate Update on 29 September 2021,
which detailed our intention to carry out a comprehensive corporate
reorganisation of our French and Swiss subsidiaries and to cancel
our dual listing on Euronext. We are pleased to confirm that this
reorganisation is now largely completed, with our new merged
company ImmuPharma Biotech SAS being the Company's only overseas
subsidiary, and the cancellation of our Euronext listing occurred
on 18 October 2021.
This reorganisation has resulted in achieving our objective of
creating a slimmer and more cost effective Company, with the
emphasis firmly on a more focused, results orientated product
development portfolio. As the next step, we now fully intend to
drive ImmuPharma forward with the objective of reaching value
inflection milestones in all our key assets as quickly as possible,
and to enter into collaborative commercial partnerships, as early
as possible, with each product in the portfolio.
Product Development Portfolio
Autoimmunity & Inflammation
P140 is the technology platform, invented by Professor Sylviane
Muller and licensed to the Company by our longstanding
collaboration partner, the Centre National de la Recherche
Scientifique ("CNRS"). The Company has been developing P140 for the
treatment of Lupus ("Lupuzor(TM)"), with the underlying hypothesis
that P140's mode of action is relevant to many autoimmune and
inflammatory conditions.
In the last three months we have made significant positive
progress across the whole P140 platform.
-- Lupuzor(TM) : on 12 August 2021, we announced that the US
Food & Drug Administration ("FDA") had approved the
commencement of the pharmacokinetic ("PK") study as part of the
preparation for the new optimised international Phase 3 trial of
Lupuzor(TM). Since then, we have been working with Avion
Pharmaceuticals ("Avion"), our exclusive US partner, our specialist
Contract Research Organisation ("CRO"), Simbec Orion together with
our three service providers, to prepare for commencement of the
study. This has progressed well and in preparing the study drug
material, we have taken the opportunity to greatly improve the
product characterisation and analytical method validations. This
has resulted in a new proprietary synthesis of P140 which gives
greater IP protection and lowers the cost of production. Final
preparations are now being actioned including updating the
Investigational Medicinal Product Dossier ("IMPD").
Ethics committee approval has been granted and volunteer
screening and selection is expected to begin in December 2021, with
dosing of volunteers in January 2022. Guided by our CRO, study
results are anticipated to be available around the end of Q1 2022.
Throughout all these preparations we have been liaising closely
with Avion, and on successful completion of the PK study we will be
actively moving forward together to commence the international
Phase 3 trial of Lupuzor(TM).
-- P140-CIDP (Chronic Inflammatory Demyelinating
Polyneuropathy): this programme is particularly exciting, as
current therapies for CIDP involve patients receiving regular
infusions of intravenous immunoglobulin G, which involves long and
arduous visits to hospitals or specialist centres and is very
expensive. The administration of P140-CIDP would be a simple
monthly injection, which could be delivered by the patients'
general practitioner or self-administered using an autoinjector
pen.
We have appointed a specialist CRO, who has completed the
protocol for a pivotal adaptive Phase 2/3 clinical trial suitable
for registration. This will shortly be presented to regulatory
authorities for review and approval. We would expect to commence
this Phase 2/3 clinical trial in 2022, on successful completion of
the current PK study.
Alongside this CRO, we have appointed Professor Jerome de Seze,
a Professor in Neurology and PhD in Immunology and Head of the
Neuroimmunological department of Strasbourg hospital. He is a
recognised specialist in CIDP and principal investigator for our
forthcoming CIDP trial and has been involved in many CIDP trials.
Professor Sylviane Muller, who has a longstanding relationship with
Professor de Seze and his work within CIDP, will provide any
necessary support for this programme.
This CIDP programme is also expected to be designated as an
orphan drug indication, which has many advantages in terms of its
regulatory pathway to market and subsequent market exclusivity. In
addition, this programme has much shorter clinical timelines than
our Lupus programme, meaning that this clinical trial could
complete ahead of our Lupuzor(TM) Phase 3 trial and potentially
reach registration and commercialisation up to a year earlier than
the Lupus indication.
The CIDP programme is gaining a lot of interest from
pharmaceutical companies who are attracted to orphan indications
and who specialise in the Neuropathy area. We are currently in
active discussions with two potential commercial partners on this
programme.
-- P140 - Other indications
As part of the ongoing research into P140 a number of new
indications have been revealed. They all share the same common
cause at the mechanistic level of the cell. Pre-clinical studies
have now confirmed P140 activity in asthma (acute and chronic),
gout and periodontitis. There have been no new significant drug
classes addressing these indications for many years.
-- P140 - Second generation
Our pre-clinical team in Bordeaux, 'ImmuPharma Biotech' headed
up by Dr Sebastien Goudreau, has commenced work to develop a
pharmacologically improved version of P140, a second generation
product that aims to further strengthen the IP position and provide
therapies with different improved administration modalities, yet
still maintaining P140 as the active moiety.
-- CNRS & Professor Sylviane Muller collaboration
Given the exciting new P140 platform of opportunities created by
Professor Muller's work, we are establishing a new broad agreement
with the CNRS, in order to support this important research, provide
therapies for other conditions, outside of Lupus and CIDP and to
maximise commercial opportunities.
Anti-Infectives
Anti-infectives was chosen as a core therapy focus because of
the ever-looming threat of new and resistant organisms, with few
significant new products or even classes having been discovered or
developed now for many years. Our proprietary peptide technology
lends itself well to taking established products and greatly
improving their pharmacology.
-- BioAMB
BioAMB is our most advanced anti-infective candidate. It is an
improved form of amphotericin-B ("AMB"), a well-established
systemic antifungal drug. It is usually reserved for 3(rd) line
therapy due to the severe side effects associated with most AMB
formulations. The toxicity associated with AMB, especially
nephrotoxicity, has always been a key challenge for this group of
drugs. Pre-clinical studies on BioAMB have demonstrated both
efficacy and none of the usual toxicity side effects associated
with existing AMB formulations. We expect further significant
updates in the first half of 2022 as we complete further
pre-clinical studies.
Similar to the P140-CIDP programme, BioAMB has attracted a lot
of attention from pharmaceutical companies who recognise the
obvious competitive profile that BioAMB offers and we are currently
in active discussions with two potential commercial partners on
this programme.
-- BioCin
BioCin is an improved form of vancomycin, a systemic
antibacterial which is highly effective against Methicillin
Resistant Staphylococcus Aureus (MRSA) and orally against
Clostridium Difficile infections. However, Vancomycin is not
absorbed from the gut and so requires administration by infusion
which is a very challenging and expensive regimen for patients and
their healthcare providers.
We have identified where we can improve a number of aspects of
the drug's pharmacology with BioCin. Whilst this programme is at an
earlier stage of development than BioAMB, we expect to gain further
insights from pre-clinical studies (PK, pharmacodynamics, efficacy
and toxicity) in 2022.
Commenting on the new corporate focus, Tim McCarthy, Chief
Executive Officer said: "The evolvement and transition of
ImmuPharma over the last few months can probably be summed up as
one of the most challenging and yet exciting periods in its
history. An enormous amount of collaborative teamwork has been
involved to achieve the vastly improved position we have presented
today.
As a Board, supported by our excellent pre-clinical team in
Bordeaux and our collaboration partners, we are all unified in our
belief that ImmuPharma is now positioned to be able to deliver on
the key objectives and timetable outlined in this announcement and
we are excited by this new phase in the evolution of
ImmuPharma.
As CEO, I am committed to delivering key value inflexion points,
as we progress through major milestones over the next 12
months."
Dr Tim Franklin, Chief Operating Officer of ImmuPharma, added :
"As a newly formed Board, our first priority is to create long term
value for our shareholders and to enhance and protect the key
assets within our portfolio.
I am delighted with the positive progress, as outlined today
with the PK study and look forward to continuing to work closely
with Avion, as Lupuzor(TM) moves through its Phase 3 trial and
towards the market.
We are also extremely pleased to be finalising a new expanded
collaboration agreement with Professor Muller and her team at the
CNRS to support the P140 franchise, and the development of the new
proprietary synthesis of the P140 molecule, is a significant step
in this direction.
Professor Sylviane Muller, Director at CNRS further said:
"Myself and the team at the CNRS have been working, over many
years, on a number of projects associated with the P140 mechanism
of action and as such, are convinced of the enormous potential of
the P140 platform and its diverse role within the whole spectrum of
autoimmunity and inflammation.
I am particularly excited to see Lupuzor(TM) moving forward
towards its next Phase 3 trial, as this drug will be literally life
changing for many Lupus patients worldwide.
I also strongly believe that the new propriety synthesis for
P140 being developed by ImmuPharma is absolutely the correct
strategy, as it creates a more protected and valuable asset.
Working in collaboration with ImmuPharma and its excellent
pre-clinical team in Bordeaux, we are confident that we will be
able to develop a number of new and innovative therapeutic
opportunities moving forward."
End
This announcement contains inside information as stipulated
under the UK version of the Market Abuse Regulation no 596/2014
which is part of English law by virtue of the European (withdrawal)
Act 2018, as amended. On publication of this announcement via a
regulatory information service, this information is considered to
be in the public domain.
For further information please contact:
ImmuPharma PLC ( www.immupharma.com )
Tim McCarthy, Chairman and Chief Executive
Officer + 44 (0) 207 152 4080
Dr Tim Franklin, Chief Operating Officer
Lisa Baderoon, Head of Investor Relations
& Non-Executive Director + 44 (0) 7721 413496
SPARK Advisory Partners Limited (NOMAD)
Neil Baldwin +44 (0) 203 36 8 3550
Stanford Capital Partners (Joint Broker)
Patrick Claridge +44 ( 0) 20 3650 3650
John Howes
Bob Pountney
SI Capital (Joint Broker)
Nick Emerson +44 (0) 1483 413500
Notes to Editors
About ImmuPharma PLC
ImmuPharma PLC (LSE AIM: IMM) is a specialty biopharmaceutical
company that discovers and develops peptide-based therapeutics. The
Company's portfolio includes novel peptide therapeutics for
autoimmune diseases, metabolic diseases, anti-infectives and
cancer. The lead program, Lupuzor(TM), is a first-in class
autophagy immunomodulator which is in Phase 3 for the treatment of
lupus and preclinical analysis suggest therapeutic activity for
many other autoimmune diseases that share the same autophagy
mechanism of action. ImmuPharma and Avion Pharmaceuticals signed on
28 November 2019, an exclusive licence and development agreement
and trademark agreement for Lupuzor(TM) to fund a new international
Phase 3 trial for Lupuzor(TM) and commercialise in the US.
For additional information about ImmuPharma please visit
www.immupharma.co.uk
ImmuPharma's LEI (Legal Entity Identifier) code:
213800VZKGHXC7VUS895.
About Simbec-Orion
Simbec-Orion, for the last four decades, has been providing
clinical trial management services across a wide range of
therapeutic indications and phases. The clinical research
organisation with a flexible, specialist approach, they strive to
become a trusted partner for their clients. Their passion as a CRO
is rare diseases and oncology.
Responding to the evolving needs of its clients has made them
the contract research organisation they are today. Offering a
full-service clinical development portfolio, but with the size,
agility, and structure to respond rapidly when needed. With a team
of experienced management, clinical research and scientific
advisory specialists, they deliver precise clinical research with
expertise.
From Phase I clinical pharmacology studies through to Phase III
rescue studies, central laboratory services , and post-marketing,
they are the CRO ready to take on the challenge - whatever the
indication or compound you are passionate about, wherever you are
in your clinical development journey. They will manage every
element of your clinical development, so you can focus on the
science. For more information go to: www.simbecorion.com
About Lupus (Systemic Lupus Erythematosus / SLE)
Lupus is a chronic inflammatory disease which is thought to
affect some 5 million individuals worldwide. The current standard
of care still consists of drugs which have many side-effects and
limited efficacy. Despite the need for an effective treatment, only
two therapies, namely GlaxoSmithKline's Benlysta and more recently,
Astra Zeneca's Saphnelo, have been approved to treat the condition
over the past 50 years. As such, there clearly exists an unmet
medical need for a drug that has a strong efficacy and safety
profile.
About CNRS
The Centre National de la Recherche Scientifique (National
Center for Scientific Research) is one of the most important
research institutions in the world. To meet the major present and
future challenges, its scientists are exploring living things,
matter, the Universe and the functioning of human societies.
Internationally recognized for the excellence of its scientific
work, the CNRS is a benchmark both in the world of research and
development and for the general public. Founded in 1939 the CNRS is
a government-funded research organization, under the administrative
authority of France's Ministry of Research and has over 30,000
employees and an annual budget of over EUR3 billion.
The CNRS has received many prestigious awards and has produced
17 Nobel laureates and 11 Fields Medal award winners. For more
information go to: www.cnrs.fr
Professor Sylviane MULLER , CNRS/Strasbourg University,
France
Professor Muller earned her doctorate in sciences at the
University of Strasbourg (France) and focused on immune responses
as a postdoctoral researcher at the Max Planck Institute for
Immunobiology in Freiburg (Germany). She is Professor at the
Institute of Advanced Studies of the Strasbourg University where
she holds the chair in Therapeutic immunology; emeritus Research
Director at the Centre National de la Recherche Scientifique;
former Director of the CNRS Unit Immunopathology and therapeutic
chemistry (2001-2017) and Director of the CNRS Institute of
Molecular and Cellular Biology (2016-2017). She was the former
Director of the Drug Discovery Center for cancer and inflammation
Medalis awarded 'Laboratory of Excellence' (2011-2020) and now, of
the Strasbourg Institute for drug development and discovery
(2021-2028; 250 persons). She received several national and
international awards (CNRS Silver Medal, CNRS Innovation Award,
Léon Velluz Prize from the French Academy of Sciences, finalist of
the 2017 European Inventor Award). She is a fellow of the European
Academy of Sciences and Member of the Academia Europaea. Her
expertise in peptide immunochemistry, combined with insights into
the molecular and cellular pathways behind autoimmune diseases, led
to the discovery of Lupuzor(TM) , a therapeutic peptide currently
evaluated in phase III-clinical trials for Lupus. Using synthetic
peptides as tools, she published numerous papers describing the
fine characterization of autoantibodies and autoreactive T
lymphocytes, especially in human lupus, and the design of
innovative vaccines. Professor Muller has filed over 30 patents and
published 395 papers and reviews in peer-reviewed journals.
In September 2021, Professor Muller was awarded the highly
prestigious Legion d'honneur Award.
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