ImmuPharma sets its sights high for drug development

ImmuPharma is one of the leading specialist drug development companies in Europe. It has been listed in London since 2006, and the company’s shares are also trading in Berlin, Germany.

The company was founded and is led by a commercially focused board and management team with extensive experience. Founded in Basel in 1999, ImmuPharma focuses on developing novel medicines with high sales potential in specialist markets with serious unmet needs. It has a number of drug candidates in development, two platform technologies and over 70 patents.

Lupuzor was licensed to US specialty pharmaceutical company Cephalon in 2009 in one of the largest deals
in Europe

ImmuPharma’s strategy is to capitalise on pioneering research, which takes place primarily at Europe’s largest fundamental research institution, the Centre National de la Recherche Scientifique (National Centre for Scientific Research, or CNRS). The CNRS was founded in 1939; it is a government-funded research organisation under the administrative authority of France’s Ministry of Research and has over 30,000 employees and an annual budget of over €3bn. The CNRS has received many prestigious awards and produced 17 Nobel laureates and 11 Fields Medal award winners. ImmuPharma has a significant collaborative research and development agreement with the CNRS that allows the company access to many scientists and doctors, keeping its costs low by avoiding the constant funding necessary for early stage research.

The company also has a collaboration with the Institut Européen de Chimie et Biologie (IECB): an international and interdisciplinary research team incubator, under the joint authority of the CNRS, the Institut National de la Santé et de la Recherche Médicale, and the University of Bordeaux.

Under development
ImmuPharma’s most advanced drug candidate is a treatment for lupus: a chronic, sometimes fatal, disease that attacks multiple organs such as the skin, joints, kidneys, blood cells, heart and lungs. According to some analysts and professional organisations, there are an estimated 1.4 million people diagnosed with the disease in the seven major markets alone (the US, Japan, Germany, France, the UK, Italy and Spain). The US Lupus Foundation believes the number is higher, estimating 1.5 million people just in the US. The rest of the world represents an additional market potential. There is no cure for the disease and only one new drug has been approved for the condition recently.

ImmuPharma’s own drug candidate, Lupuzor, has a novel mechanism of action aimed at modulating the body’s immune system so it avoids attacking healthy cells but also does not cause its own adverse side effects. It has the potential to halt the progression of the disease.

Lupuzor was licensed to US specialty pharmaceutical company Cephalon in 2009 in one of the largest deals in Europe. Cephalon paid ImmuPharma $15m before the results of the Phase IIb study for the exclusive option to enter into the worldwide licence. Following positive results of ImmuPharma’s Phase IIb study in early 2009, Cephalon exercised its option by paying a further $30m for an exclusive worldwide licence. This was part of a corporate deal worth over $500m in cash milestone payments, on top of high royalties on product sales. In addition, Cephalon assumed all responsibilities and costs for the development and commercialisation of Lupuzor.

In 2011, Cephalon was taken over by Teva Pharmaceuticals and, based on key provisions of the agreement between ImmuPharma and Cephalon, ImmuPharma requested and was granted the return of the rights for Lupuzor. This came at an exciting stage in the drug’s development: the FDA had granted Lupuzor approval to start Phase III with a Special Protocol Assessment with Fast Track designation, shortening the approval time by about a year.

Working together
ImmuPharma has appointed some of the world’s most eminent physicians to provide scientific advice and support for Lupuzor’s pivotal Phase III programme. The Scientific Advisory Board members are: Dr Daniel J Wallace, Associate Director of the Rheumatology Fellowship Programme at Cedars-Sinai Medical Centre in Los Angeles, Clinical Professor of Medicine at the David Geffen School of Medicine at UCLA, and Expert Reviewer for the Medical Board of California; Professor David Isenberg, Professor of Rheumatology at University College Hospital in London; Professor Vibeke Strand, Clinical Professor and Adjunct at Stanford University School of Medicine’s Division of Immunology and Rheumatology; Professor Cees GM Kallenberg, Professor of the Department of Rheumatology and Clinical Immunology at University Medical Centre Groningen; and Dr Lee S Simon, Principal, SDG and former FDA Division Director.

The company has secured a £50m, five-year, Equity Financing Facility with Darwin Strategic, a majority-owned subsidiary of Henderson Global Investors’ Volantis Capital, which can be used to fund Lupuzor. In addition, in October 2014, ImmuPharma raised approximately £3.4m through the issue of new shares, at a premium to the share price.

ImmuPharma has recently signed a collaboration agreement with Simbec-Orion Group for the execution of ImmuPharma’s Pivotal Phase III clinical study of Lupuzor. Simbec-Orion is a full-service international clinical research organisation specialising in rare and orphan conditions, and has previous direct experience in Lupus trials. Simbec-Orion has revenues of approximately £25m, employs approximately 250 staff and has operations across Europe, Australia and the US, together with capabilities in multiple other territories.

Breakthrough treatments
ImmuPharma’s anti-cancer programme, IPP-204106, has a dual mechanism of action, acting both in preventing angiogenesis and proliferation. Data on IPP-204106 has been obtained that confirms the ability of the compounds to effectively control and stop the growth of a large panel of human cancer cell lines, both in vitro and in vivo. Collectively, the studies covered breast cancer, prostate cancer, melanoma, glioblastoma, leukaemia, colon cancer and pancreatic cancer cell lines.

The programme has been awarded grants of over €1m from the French national research agencies. In May 2011, the drug was chosen to feature on the front cover of Cancer Research, the prestigious medical journal of the American Association for Cancer Research. The key findings of the study published by the association were that the compound: inhibits growth of several tumour cell lines, xenograft models and blocks angiogenesis; rapidly localises selectively in tumour tissue; promotes apoptosis (the death of cells, a key approach in the treatment of cancer); and has a novel mechanism of action, acting on nucleoproteins on the surface of cancer cells.

Ureka, one of ImmuPharma’s fully owned subsidiaries, is a pharmaceutical R&D unit, with its internal research team based at the Institut Européen de Chimie et Biologie (IECB) in Bordeaux. Through its network, the IECB hosts 15 international and multi-disciplinary research teams. Among them is the CNRS team of Dr Gilles Guichard, one of the scientific founders of ImmuPharma and a leading researcher in peptides.

The long-standing collaboration with the CNRS under Dr Guichard and Ureka has resulted in the filing of a new co-owned patent controlling a breakthrough peptide technology called ‘Urelix’. The new technology makes it possible, in essence, to mimic long natural peptides – especially in the configuration used to bind their receptors and improve their stability to enzymatic degradation (i.e. breakdown of peptides into amino acids) as well as greater efficacy. The first therapeutic area being targeted is diabetes. Blocking the protein/protein interaction could also be used in fighting viruses (by blocking virus entry into cells), which could be further investigated.

The potential of this technology is substantial and diverse, and is one of the key reasons Ureka has established its own research team (some provided by Dr Guichard’s laboratory, others by other prestigious universities such as ETH Zurich), working in close collaboration with Dr Guichard and his CNRS team. Within this collaboration, the IECB’s incubator on the campus of the University of Bordeaux has provided ImmuPharma with access to state-of-the-art laboratories and a number of scientists.

The French region of Aquitaine (around Bordeaux) has awarded Ureka a non-refundable grant of approximately €400,000 to develop its Urelix technology.

Prestige and recognition
ImmuPharma was founded and is run by an experienced international management team of ex-big pharma and investment banking executives. They each previously held senior positions in the industry, including at GlaxoSmithKline, Roche, Novartis, Bristol Myers-Squibb, UBS, Commerz Bank and ABN Amro. Since its foundation, the company has attracted interest from prestigious institutional investors, including ING Belgium, M&G, Gartmore, Jupiter, Aviva, Schroders Life Sciences, Legal & General, Close, Standard Life, Odey Asset Management and Pictet.

The company’s work has won recognition from a number of notable organisations. It was the winner of the Breakthrough of the Year 2009 European Mediscience Award, sponsored by Piper Jaffray, the Best Technology Award at the AIM Awards 2009, organised by the London Stock Exchange, and was named Best Drug Development Company in Europe by The New Economy Pharmaceutical and Healthcare Awards for 2010. And, in 2014, it was awarded the New Economy Award for Most Innovative Drug Licensing and Development Company.