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ImmuPharmaAnnouncement

18/11/2021 07:00

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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™ PK study on track to deliver results in Q1 2022 and to move
into Phase 3 thereafter

·   P140/Lupuzor™:  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™"), 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™: 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™. 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™.

 

·    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™ 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™ 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™ 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 (http://www.immupharma.com) )        + 44 (0) 207 152 4080

 Tim McCarthy, Chairman and Chief Executive Officer
 Dr Tim Franklin, Chief Operating Officer
 Lisa Baderoon, Head of Investor Relations & Non-Executive Director      + 44 (0) 7721 413496

 SPARK Advisory Partners Limited (NOMAD)                                 +44 (0) 203 368 3550

 Neil Baldwin

 Stanford Capital Partners (Joint Broker)                                +44 (0) 20 3650 3650

 Patrick Claridge

 John Howes

 Bob Pountney

 SI Capital (Joint Broker)                                               +44 (0) 1483 413500

 Nick Emerson

 

 

 

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™, 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™ to
fund a new international Phase 3 trial for Lupuzor™ 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
(https://www.simbecorion.com/service/central-laboratory-support/) , 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 (http://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 €3
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 (http://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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