ImmuPharma plc

Statement from the Interim Chairman, the President and the Chief Executive Officer

 

INTERIM HIGHLIGHTS

 

Summary

 

Although we are pleased to highlight our interim results for the six months ended 30 June 2015, we are saddened by the passing of our Chairman, Richard Warr.  Richard was one of the three co-founding executive directors of ImmuPharma.  In the short term, our senior non-executive director, Franco di Muzio, has been acting as Interim Chairman. In a separate announcement issued today, Tim McCarthy, an experienced healthcare director, has been appointed Non-Executive Chairman with immediate effect.  We have further strengthened the Board by the appointment of Dr Stephane Mery, an experienced scientist, investor and industry executive, as a Non-Executive Director.

 

During 2015, we have made exciting progress on all of our key programs.  We have begun the pivotal Phase III trial for Lupuzor^TM (P140), a breakthrough treatment for the auto-immune disease lupus,  with our development partner, Simbec-Orion. Our Nucant program, IPP-204106, is progressing with combination therapy approaches and grant-funded ophthalmological indications.  We announced in February that the Phase I/IIa dose-finding adaptive study where the Nucant was associated with chondroitin sulphate demonstrate that the maximum tolerated dose was 9 mg/kg.  This was the primary objective of the study.  These Phase I/IIa results now allow ImmuPharma, from a regulatory perspective, to commence a Phase II study.  Separately, our peptide technology collaboration at the University of Bordeaux is now well established and moving forward. 

 

We were honoured to see our collaborator, Dr Sylviane Muller, the key inventor of Lupuzor^TM and Research Director at the Centre National de la Recherche Scientifique (CNRS), receive 'The CNRS Medal of Innovation' for her discoveries made on the mechanism of action of Lupuzor^TM and its applications to other autoimmune diseases.  In addition, ImmuPharma was delighted to have been awarded the New Economy Award for Most Innovative Drug Licensing and Development Company.

 

 

Development Pipeline Highlights

 

·      Lupuzor^TM

 

Lupuzor^TM also referred to as IPP-201101 or P140 is a potential treatment for lupus (or Systemic Lupus Erythematosus), a chronic, potentially life-threatening auto-immune disease, Lupuzor^TM has a novel mechanism of action aimed at modulating the  immune system and has the potential to halt the progression of the disease in a substantial proportion of patients. A certain number of patients suffering from other autoimmune diseases may, according to preclinical data generated by the group of Sylviane Muller (CNRS), benefit from P140. A Phase II/III study for an orphan indication is expected to be filed this year and may benefit from US and/or French funding or loans.

 

Lupuzor^TM has been granted Fast Track status by the US FDA and approval to start a pivotal Phase III trial under Special Protocol Assessment (SPA).  This SPA was subsequently amended due to its strong safety and efficacy profile to allow for a reduced number of patients in the Phase III trial thereby reducing the projected cost of development considerably. 

 

Together with our development partner, Simbec-Orion, this pivotal Phase III trial has begun and is due to recruit patients.  The trial's progress can be tracked on 'Clinicaltrials.gov' and is entitled: 'A 52 week, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200 mcg Dose of IPP-201101 Plus Standard of Care in Patients with Systemic Lupus Erythematosus'. 

 

 

 

ImmuPharma plc

Statement from the Interim Chairman, the President and the Chief Executive Officer (continued)

 

·      IPP-204106, Nucant program

 

IPP-204106 is ImmuPharma's lead compound for cancer and other indications.  The rights for this compound have been obtained through the Group's ongoing research collaboration with the Centre National de la Recherche Scientifique (CNRS).  The molecule is a nucleolin antagonist and has a promising and novel mechanism of action, acting on modulating angiogenesis as well as proliferation.  Preclinical data has shown that nucleolin antagonists inhibit the growth of tumours and metastasis in many cancer types.  Results from the initial Phase I/IIa trial in cancer patients demonstrated that it met its safety endpoints and showed stabilisation of disease in 21% of patients.  The further Phase I/IIa clinical trial designed to assess safety of increasing doses and to identify the optimal dose for treatment that had been ongoing in France and Belgium has been completed. 

 

While safe doses have been established for the stand alone use of these compounds, we are investigating the possibility that the compounds have promising potential as combination therapies.  The Nucant's ability to bind selectively to membrane nucleolin that is seen only in proliferating cells has led us to develop a Nucant-based selective targeting system to safely deliver cytotoxic drugs.  In addition, we have been granted new composition of matter patents surrounding an 'optically pure' version of ImmuPharma's Nucant family which broadens our usage into other indications in addition to cancer.  This new patent family covers millions of peptide constructs and also expands the potential uses to include angiogenesis related conditions such as age-related macular degeneration, diabetic retinopathy and wound healing as well as cancer selective targeting systems. 

 

ImmuPharma has been awarded a grant to investigate the Nucant program's applicability to this ophthalmological indication and progress is underway.

 

·      Peptide technology platform collaboration

 

ImmuPharma has also initiated the development of a novel and innovative peptide technology platform through the collaboration with our longstanding and successful research partner, CNRS, thereby gaining access to pioneering research centred on novel peptide drugs at the University of Bordeaux and the Institut Européen de Chimie et Biologie (IECB).  IECB is an international and interdisciplinary research incubator, placed under the joint authority of the CNRS, INSERM (Institut National de la Santé et de la Recherche Medicale) and the University of Bordeaux. Through its network, IECB hosts 15 international and multi-disciplinary research teams including the CNRS team of Dr Gilles Guichard, one of the scientific founders of ImmuPharma and a leading researcher in peptides.  Additionally, ImmuPharma has established a significant research entity located within the IECB campus comprising 3 PhDs from Dr Guichard's lab and ETH Zurich as well as state-of-the-art equipment. 

 

The longstanding collaboration with the CNRS under Dr Guichard and ImmuPharma has resulted in the filing of a new co-owned patent controlling the breakthrough peptide technology codenamed 'Urelix', allowing the mimicry of long, natural peptides particularly in the configuration used to bind to their receptor, the potential improvement of their stability against enzymatic degradation (breakdown of peptides into amino acids) and greater efficacy. 

 

 

ImmuPharma plc

Statement from the Interim Chairman, the President and the Chief Executive Officer (continued)

 

 

·      Peptide technology platform collaboration (continued)

 

The first therapeutic area being targeted is diabetes with glucagon-like peptide -1 agonists or GLP-1 agonists, a class of drugs for the treatment of type 2 diabetes and is initiating the development of novel peptides as glugacon antagonists, one of the novel approaches to treat Type I and Type II diabetes.  According to Research and Markets (August, 2011), this family represents a potential market of approximately $10 billion.  The potential of this technology is substantial and diverse and is one of the key reasons ImmuPharma has established its own research team working in close collaboration with Dr Guichard and his CNRS team.  These developments also involve our patented chemical library of over 300,000 peptide-like small molecules. 

 

ImmuPharma's subsidiary, Ureka sarl, was awarded a grant of approximately €400,000 to support this work.

 

 

Financial Review

 

ImmuPharma's cash balance at 30 June 2015 was £3.29 million (£5.42 million at 31 December 2014).  Basic and diluted loss per share were 1.74p and 1.74p respectively (31 December 2014: 3.43p and 3.43p).  In line with the Company's current policy, no interim dividend is proposed.

 

ImmuPharma continues to emphasise prudent and controlled expenditure.  Operating loss for the Period was £1,537,274 (£1,818,412 for the six months ended 30 June 2014).  Research and development expenditure in the Period was £494,567 (£820,357 for the six months ended 30 June 2014) reflecting primarily the activities for the development of the Urelix^TM peptide technology collaboration and the Nucant program.  Administrative expenses were £1,056,266 during the Period (£998,055 for the six months ended 30 June 2014).

 

Given the stage of ImmuPharma's development, the fact that losses have continued to be made is to be expected since there is minimal revenue and business activity is concerned with clinical trial expenditure and maintaining the infrastructure of the Group.

 

Current Activities & Outlook

 

We have concentrated our efforts over the last period of progressing Lupuzor™ through the initial regulatory and feasibility stages of the Pivotal Phase III process to the point where we are now starting to recruit patients within Europe and USA.

 

ImmuPharma in conjunction with the CNRS are also working hard on progressing the P140 auto immune pipeline, based on Lupuzor^TM's strong efficacy and safety profile and illustrated by its mechanism of action as lauded by the inventor Dr Sylviane Muller. We hope to be able to share further data on preclinical studies of other indications of P140 later this year together with plans for progressing a number of indications into clinical studies.

ImmuPharma plc

Statement from the Interim Chairman, President and Chief Executive Officer (continued)

 

 

Current Activities & Outlook (continued)

 

In summary, the focus of the Group is on ensuring the smooth progress of the late stage clinical development of Lupuzor^TM, exploring other opportunities around Lupuzor^TM's mechanism of action and its applicability to other autoimmune conditions with Orphan Drug Status together with progressing ImmuPharma's other pipeline candidates. 

 

We look forward to providing further progress updates over the next period.

 

 

 

Dr Franco di Muzio, Interim Chairman and Senior Non-Executive Director

 

Dr Robert Zimmer, MD, PhD, President and Chief Scientific Officer

 

Dimitri Dimitriou, MSc, Chief Executive Officer

  

 

 

29 September 2015