Xenetic Biosciences plc
('Xenetic' or 'the Company')
Scientific Advisory Board ("SAB") Appointments
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 the appointment of both Dr Subash Kapre PhD and Thomas Ulich, M.D. as members of its Scientific Advisory Board.
Dr Kapre (65) gained his MSc in Biochemistry at Pune University in 1969, later being awarded his PhD in Microbiology in 1977.
In 1969 he joined Serum Institute of India ("Serum") direct from university from which date to now Dr Kapre has devoted his professional lifetime to the increasing success of Serum culminating in his appointment in 1992 as Executive Director. He has had full-time, hands-on experience in every aspect of development, manufacture, marketing and business development and has been a key driver in building Serum from a small-scale domestic vaccine producer into India's largest biotech business and one of the world's largest vaccine manufacturers. He has been honoured by Serum Institute of India as Director Emeritus upon his retirement.
Dr Kapre has been in the forefront in the development of polysialylic acid (PSA) facility in Pune, the core technology lying at the heart of PolyXen™, one of Xenetic's technology platforms. Similarly he had key responsibility for the clinical development of ErepoXen®, the jointly-owned long-acting polysialylated erythropoietin product jointly being developed by Xenetic and Serum and which is currently in Phase II clinical trials in India.
Dr Kapre has been on the board of directors in the US by holding positions on two publicly-traded companies. He is active in playing pivotal roles in establishing collaborative research as well as projects involving global agencies. He is recognised by several Indian government departments and banks as a skilled consultant on scientific issues and holds numerous international memberships.
He has been a prolific contributor to companies and organisations across the globe, including having delivered many lectures at globally recognised symposia on the multiple areas of scientific interest and activity in which he is expert.
Dr Ulich (58) attained his Bachelor's degree from Dartmouth College in 1975 then gained his medical qualification at the University of California at Irvine and San Diego in 1979, followed by a 3 year Pathology residency at UCLA. He then spent 2 years as National Kidney Foundation Fellow at the Scripps Research Foundation Department of Immunology. From 1984-2005 he held numerous influential positions at the University of San Diego Irvine Medical School culminating in his appointment as Professor of Pathology.
From 1993-2003 Dr Ulich worked at AMGEN as VP of Preclinical Development, which role was ultimately expanded to encompass responsibility for Protein Therapeutics where he was responsible for a team of 600 scientists. He played a role in the launch of many of Amgen's blockbuster products. The following 2 years saw him as Senior VP of R&D at Alnylam Pharmaceuticals with work culminating in that company's successful IPO in June 2004.
From 2005-6 he held the appointment of Professor of Pathology at Wayne State School of Medicine at Detroit as Pathology Director on the Pathophysiology Course, after which he moved back into a commercial role at ConjuChem Inc in Montreal where, from 2006-2010, he was Executive VP of Research and Development.
Dr Ulich has a demonstrably wide experience including multiple IND (Investigational New Drug), Biologic License Application ("BLA") and Market Approval filings gained in his many years in businesses at a similar stage of development with directly comparable clinical and commercial aspirations as Xenetic.
Commenting, M. Scott Maguire, CEO of Xenetic, said:
"The Company with these two key appointments deepens its senior scientific capabilities in the US. We are delighted that Subash and Tom have agreed to collaborate with Xenetic as important contributors to the Scientific Advisory Board ("SAB").
Along with the recently announced appointment of Dr Surender Kharbanda, there can be no doubt that Xenetic is now be able to draw on the massive body of experience and hands-on knowledge vested in the SAB as we roll out our clinical drug development programmes in the US and Europe. This can only serve to underpin the likelihood of ongoing clinical success and generation of shareholder value. The Company expects to announce further appointments to the SAB due course."
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 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 to form Xenetic's new Drug Development Centre of Excellence in Massachusetts. 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