14 May 2012
Xenetic Biosciences plc
('Xenetic' or 'the Company')
Appointment of Vice President for Drug Development
Xenetic Biosciences plc (LSE: XEN.L), a bio-pharmaceutical company specialising in the development of high-value differentiated biological and vaccines and novel cancer drugs, announces that Dr Henry Hoppe IV has been appointed as Vice President of Drug Development for the Company.
Dr Hoppe is a leading biotechnology drug development executive with over 20 years' experience in recombinant protein, monoclonal antibody and stem cell expression for clinical therapies. His is a key appointment for Xenetic that is a pivotal step in establishing the Company's new Drug Development Centre in Boston. Dr Hoppe's principal expertise lies in the processes surrounding regulatory submissions, IND filings and clinical trials, especially in the orphan and rare disease arena, exemplified in his 17 years at Genzyme Corporation where he was instrumental in the development and launch of many of their leading products.
About Dr Hoppe
Dr Hoppe is a biotechnology process development executive with over 20 years experience in recombinant protein, monoclonal antibody and stem cell expression for clinical therapies. He has written and reviewed IND/NDA CMC sections for numerous recombinant protein and gene therapy programs, including those for Cerezyme®, Fabrazyme®, Myozyme® and Thyrogen®, being four currently marketed products of the Genzyme Corporation. He has amassed more than 20 years experience with all aspects of therapeutic development from the bench through Phase II clinical trials including managing Clinical Manufacturing Organisations (CMOs) in both the United States and Europe.
Dr Hoppe graduated with a Ph.D. in Genetic Toxicology from the Massachusetts Institute of Technology (MIT) in 1980 having first gained his Bachelors degree at MIT in 1973. Between 1980 and 1984, Dr Hoppe held positions at the Harvard Medical School and the University Hospital of Boston.
From 1984 to 2001, Dr Hoppe worked for Genzyme Corporation focussing on therapies for rare genetic diseases. He was subsequently appointed Vice President of Therapeutic Development for ViaCell Inc. where he delivered stem cells to clinical trials and designed Phase II manufacturing processes.
In 2004 Dr Hoppe founded his own consultancy business, BioDevelopment Consulting, to provide expertise on advancing therapies from research into Phase I and Phase II clinical trials.
Dr Hoppe has Inventor status on four US granted patents addressing oncology, anaemia and cystic fibrosis diseases. He has authored numerous articles in noted scientific journals and been the keynote speaker at a number of leading industry conferences.
Commenting on Dr Hoppe's appointment, M. Scott Maguire, CEO of Xenetic, said: "We are very pleased indeed to bring Henry on board; he will be instrumental in building up our Drug Development Centre in Boston and executing our plans for advancing drugs into FDA clinical development and eventual market launch. Henry's extensive drug development knowledge and experience gained during his years at Genzyme and his years as a leading consultant will be hugely valuable to Xenetic as we roll out our clinical programmes in the US and Europe. Henry played an important role in the growth of Genzyme from a small biotech to a major corporation which was recently acquired by Sanofi Aventis in an $20.1 billion deal. Genzyme built its business with a major focus on developing novel therapies for Rare and Orphan Diseases; this is the path that Xenetic is following and Henry's front line experience in Genzyme (and elsewhere) has given him a near unparalleled depth of knowledge which I believe will greatly enhance the effective execution of our clinical development plans; his contribution is therefore expected to be a key driver in unlocking the huge therapeutic potential of Xenetic's three current patent-protected enabling and platform technologies which, in turn, will generate shareholder value that fully reflects the inherent worth of this Company."
Notes to Editors
Xenetic Biosciences plc (formerly Lipoxen plc) is a biopharmaceutical company focused on the development of new and improved biologic drugs and vaccines.
Xenetic's technology is designed to improve the efficacy, safety, stability, biological half-life and immunologic characteristics of its products using its three proprietary patented technology platforms:
for extending the efficacy and half life of biologic drugs
for creating new vaccines and improving existing vaccines
for oncology drugs
The Company has multiple drug and vaccine programmes in pre-clinical development with three products currently in human clinical development:
A long-acting insulin with two ongoing trials in Russia being, (a) for the treatment of diabetes, and (b) for a central nervous system (CNS) condition.
A long-acting erythropoietin (EPO) currently in Phase II(b) trials in India. ErepoXen is a novel therapy for the treatment of anaemia in both End Stage Renal Disease patients and for those undergoing chemotherapy
A recombinant human histone H1.3 molecule in Phase I clinical trials in Russia for refractory Acute Myeloid Leukaemia ((AML) and Non Hodgkin's Lymphoma (NHL)
The Company has an important license agreement with Baxter International Inc to develop a novel series of polysialylated blood coagulation factors, including Factor VIII. In 2010, Xenetic and Baxter announced positive results with a PSA-Factor VIII candidate in a series of preclinical studies and the selection of a lead candidate, providing confidence in the programme's potential to transition into clinical development. The success of the Baxter programme will ultimately result in the development of novel longer-acting therapies for the treatment of haemophilia.
Xenetic's ongoing clinical proprietary product pipeline includes:
ErepoXen® (Polysialylated Erythropoietin)
ErepoXen is a new product candidate from Xenetic, currently undergoing Phase II(b) clinical trials. The product offers an improved form of erythropoietin (EPO). EPO is a hormone produced by the kidneys to maintain red blood cell production and prevent anaemia. Chronic renal (kidney) failure or chemotherapy to treat cancer can cause anaemia. In cases of renal failure, the kidneys no longer manufacture enough EPO hormone and this causes anaemia. EPO therapy is the treatment of choice for this type of anaemia. The benefits of ErepoXen are:
1. Reduction in the frequency of dosage
2. Reduction in immunogenicity
3. Reduction in toxicity
A further potential benefit of ErepoXen® is that it uses polysialic acid (PSA). PSA is a polymer of sialic acid (a sugar) and it is found naturally in the human body. Most importantly, PSA is completely biodegradable and does not accumulate in the body over time.
ErepoXen® is currently in Phase II clinical development in collaboration with our partner, the Serum Institute of India.
SuliXen® (Polysialylated Insulin)
SuliXen® is a proprietary human insulin new product candidate from Xenetic, which offers potential for the treatment of type II diabetes. It is a long acting injected form of insulin with a performance profile modelled on the existing "best in class" product.
The compound has successfully completed Phase I clinical studies in Russia where it has also commenced a Phase I trial for a CNS (central nervous system) indication.
MyeloXenTM (Liposomal Multiple Sclerosis vaccine)
MyeloXen™ is a liposomal vaccine being developed in collaboration with Pharmsynthez for the treatment of multiple sclerosis. Multiple sclerosis is a progressive disease of the central nervous system accompanied by various neurologic symptoms. The disease usually occurs in young and middle age people under the influence of a series of internal and external factors. Multiple sclerosis progresses through initial difficulties in moving through to full paralysis, sensory loss as well as loss of control over neuropsychological processes. Hundreds of thousands of people suffer from Multiple sclerosis. Therefore it is extremely important to develop novel that drug products that are superior to current treatments.
This product has received regulatory approval to enter Phase I clinical trials in Russia and is currently at the patient-recruitment stage.
OncoHist (Recombinant human Histone H 1.3)
OncoHist is a novel bio-therapeutic molecule for the treatment of tumours, in particular, haematologic malignancies. It is being jointly developed by Xenetic and our recently acquired German subsidiary, SymbioTec GmbH. The product is currently in human clinical trials in Russia for the treatment of both refractory Acute Myeloid Leukaemia and for Non Hodgkin's Lymphoma.
The Company's pre-clinical pipeline includes these candidates:
Xenetic's H1N1 influenza vaccine candidate is based on our proprietary liposomal co-delivery technology and is not reliant on the classical egg-based methods of manufacture, which are time-consuming and expensive . Our preclinical data has demonstrated that a single dose of vaccine can induce protective immunity using less antigen than is found in conventional flu vaccines.
Business model, strategic equity placing and current developments
The Company has a low-risk business model and out-licenses its proprietary technologies to biopharmaceutical companies that have strong manufacturing and marketing capabilities.
Xenetic currently has commercial agreements with some of the world's leading biotechnology and pharmaceutical companies including Serum Institute of India (the Company's second largest shareholder) Baxter (also one of the Company's largest shareholders) and Schering-Plough (part of the global Merck group).
In November 2011 Xenetic completed an important equity raise with the newly-formed Russian entity, SynBio LLC. SynBio brought together the skills base of two of Russia publicly traded life sciences corporations (Pharmsynthez and Human Stem Cell Institute) with the capital of Rusnano, the Russian state-controlled nanotechnology fund which, together with the state-sponsored Skolkovo project, is intended, inter alia, to establish a domestic Russian pharmaceutical industry, this being one of the key objectives in Russia's strategic development plan to evolve from a resource-dependent economy to a knowledge-based one.
Concomitant with the equity placing with SynBio, the two companies entered into an important 6-product Co-Development Agreement under the terms of which SynBio is to carry out all necessary pre-clinical development on each product and, as appropriate, move the products into Phase I human clinical trials. Based on the output of this work (all of which data is available to Xenetic) the Company can make an informed and data-supported decision to take each successful product into clinical trials in the West. This approach substantially de-risks the clinical trial process for Xenetic as each decision can be based on known success in the relevant Russian trials. The CDA with SynBio substantially mirrors an earlier agreement with Pharmsynthez under which contract a further six candidates are in course of development, with one vaccine product ready to enter human clinical trials this year.
The SynBio transaction (which resulted in a current holding of around 45% in Xenetic's equity capital) injected more than £12m of new equity capital into Xenetic which funds are being applied to reduce the company's dependence on third party collaborators and commence clinical development in the West of its proprietary drug and vaccine pipeline. A key part of this strategy is the establishment in Boston, Mass., of a new drug development centre of excellence and the recruitment of new senior executive management with strong drug development and regulatory experience. The first two programmes to be moved into Western clinical trials will be ErepoXen and OncoHist.
More news on this front will be announced in June at the global Bio International Convention being held in Boston when the Governor of Massachusetts will be announcing Xenetic's introduction to the Boston Life Sciences hub.
The Company is currently in the process of establishing a world-class Scientific Advisory Board to work alongside and provide strategic guidance to the executive directors and the senior management team., around whom the necessary people and facilities will be built as Xenetic's new Centre of Excellence takes shape. The Company is also recruiting leading practitioners to provide hands-on consulting services for the advancement of specific products into the clinic.
Xenetic was founded in 1997 as Lipoxen Technologies Limited, which company was admitted to AIM in January 2006 as LIPXOEN plc. The Company trades on the AIM Market of the London Stock Exchange under the ticker symbol XEN. More information can be found at the Company's website: www.xeneticbio.com