Xenetic Biosciences moves drug development program to Massachusetts

13 June 2012
Xenetic Biosciences moves drug development program to Massachusetts
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 its formal decision to establish its new Drug Development Centre of Excellence in Massachusetts in an announcement coming in the run-up to the BIO 2012 International Convention being held in Boston June 18-21, 2012 at the Boston Convention & Exhibition Center, MA

This announcement was first made by the Massachusetts Life Sciences Centre on 12 June 2012.

Boston, June 12, 2012 -- Xenetic Biosciences plc ("Xenetic"/"XEN"/the "Company"), Governor Deval Patrick and the Massachusetts Life Sciences Center announced today that the UK-based, publicly-listed company plans to relocate its drug development operations to Massachusetts.  Xenetic is a specialty drug development company with an extensive proprietary product pipeline with a primary focus on rare and orphan diseases.  The Company is headquartered in London and, historically, has conducted all of its in-house optimisation and pre-clinical development work at its own laboratories.  The relocation decision follows the March 2011 visit to the UK by Governor Patrick and a delegation of state leaders from industry, academia and government to promote mutually beneficial collaborations.  The first discussion with Xenetic took place during that trade mission.  The company intends to hire up to 6 employees in Massachusetts before the end of the year and has plans to build the new Drug Development Center to around 20 by the end of 2013.
"Thanks to our investments in education, innovation and infrastructure, Massachusetts is a great place for international life sciences companies to do business," said Governor Patrick. "Stemming from last year's trade mission to the UK, we have worked closely with Xenetic to encourage them to come here and we look forward to seeing them create jobs and opportunities in the Commonwealth."

In November 2011 Xenetic completed an important financing round and is now well-positioned to initiate a number of FDA/EMA clinical programs, a strategy that demands the bringing on board of a greatly expanded set of skills.  Over the last 12 months the Company has evaluated a number of potential locations, and, while all sites offered some level of support, Management has concluded that Massachusetts can deliver the most comprehensive set of programs needed to facilitate the rapid establishment of its Drug Development Center of Excellence. The Company is currently working closely with the Massachusetts Life Sciences Center to facilitate these plans, targeting the opening of their new facility in the next few months - likely in the Waltham/Lexington area.

M. Scott Maguire, a native of Boston and CEO of Xenetic, said: "Committing our company's entire drug development operations to Massachusetts is certainly a bold step but is surely one which presents an excellent opportunity to prove ourselves as a leading technology provider in the quest to develop better drug therapies which address areas of unmet need and confer genuine advantage to both patients and providers.  We have worked closely with the Patrick Administration as we made this decision, and I have every confidence that the team in Massachusetts will be working with us every step of the way to maximize the likelihood of this being another great success for the Massachusetts supercluster!"
With a focus on Orphan and Rare Disease drug development (for example, Xenetic's OncoHist® molecule has received designation as such from both the FDA and EMA) the Company believes that there is no region anywhere in the world that can currently compete with Massachusetts in the breadth of skills, experience and resources available to a company at this stage of its growth.

Xenetic comes to Massachusetts with extensive technology offerings, each of which is designed to improve the efficacy, safety, stability, biological half-life and immunologic characteristics of the Company's product portfolio which is being built, currently, on three core technologies:  

PolyXen®                     for extending the efficacy and half life of biologic drugs
OncoHist®                   for novel mode of action drugs for oncology therapies
ImuXen®                      for creating new vaccines and improving existing vaccines

The Company has multiple drug and vaccine programs with three products currently in human clinical development.  A further key commercial stratagem is that, by means of reformulating existing APIs with their all-natural technologies, Xenetic is well-positioned to develop a broad range of bio-superior product candidates using both the PolyXen and ImuXen enabling platforms.  The Company has broadened its portfolio of all-natural technologies through the acquisition in January 2012 of the OncoHist molecule.  Xenetic will continue to seek new opportunities to extend its clinical reach into areas of high unmet need, whether through platform technologies or otherwise.

The first step in establishing the Company's new Drug Development Centre of Excellence in Boston, was the Company's announcement in May 2012 of the appointment of Dr. Henry Hoppe IV as VP of Drug Development. Dr Hoppe is a leading biotechnology executive with over 20 years experience in drug development. 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. Dr. Hoppe has Inventor status on four US-granted patents addressing oncology diseases, anaemia and cystic fibrosis, each of which holds potential significance in Xenetic's development plan.

Complementing Xenetic's presence in Boston, and being a strong advocate for the clinical development of OncoHist® in the USA in its primary indication of Acute Myeloid Leukemia, is Dr. Surender Kharbanda, who, since 1986, has held a number of research and academic positions at the Harvard Medical School and numerous scientific advisory board and executive level positions at Boston-based biotech companies focused on cancer drug development. With a track record of successful drug development, Dr. Kharbanda, who has worked at the Dana-Farber Cancer Institute and oncology-focused biotechnology companies on the molecular biology of human cancer and the development of anti-cancer agents for nearly 25 years, will be a key adviser to the Company as it establishes foundation contacts in the oncology field with both Key Opinion Leaders and with charitable foundations in the USA.  Dr Kharbanda will be a member of the Company's Scientific Advisory Board.

Xenetic will shortly be announcing the appointment of several new appointees to their SAB which will be a US-centric body with members drawn both from the commercial and academic worlds with a remit to deliver timely product and market focused strategies for the most effective application of capital into new development programs aimed at both delivering improved outcomes for patients and enhanced shareholder value for investors.

Through the Massachusetts Life Sciences Center, Massachusetts is investing $1 billion over ten years in the growth of the state's life sciences supercluster. These investments are being made under the Massachusetts Life Sciences Initiative, proposed by Governor Deval Patrick in 2007, and passed by the State Legislature and signed into law by Governor Patrick in 2008.

"We are excited to welcome Xenetic to the Massachusetts Life Sciences Supercluster," said Susan Windham-Bannister, Ph.D., President & CEO of the Massachusetts Life Sciences Center. "Their presence here will contribute to our economy and strengthen our state's global leadership in the life sciences. I am confident that Xenetic will find all of the resources and partners that the company needs to grow and succeed right here in Massachusetts."

"Massachusetts, a global leader in the life sciences, is proud to welcome Xenetic.  Their decision to locate in Massachusetts is a clear reflection of the international strength and draw of the Commonwealth's innovation economy ecosystem and the success of the Administration's continued commitment to fostering a thriving life sciences supercluster," said Ken Brown, Executive Director of the Massachusetts Office of International Trade and Investment. "We congratulate Xenetic and look forward to partnering with them."

The announcement comes as the state is preparing to host the 2012 BIO International Convention, being held June 18-21 at the Massachusetts Convention & Exhibition Center.  The Convention provides state and industry leaders an opportunity to showcase Massachusetts as a great place to do business for international life sciences companies.

"We are thrilled to welcome an innovative company like Xenetic to Massachusetts and look forward to working with their team to make them feel at home here," said MassBio President & CEO Robert K. Coughlin. "We know that international companies looking to grow in the United States will not find a more concentrated and diverse life sciences supercluster anywhere."

Xenetic Biosciences
For more information about the Company, please go to: www.xeneticbio.com
M. Scott Maguire
+44 203 021 1500
[email protected]
Anguss G. McQuilken for the Massachusetts Life Sciences Center
+1 617 921 7749
[email protected]
About the Massachusetts Life Sciences Center
The Massachusetts Life Sciences Center ("the Center") is a quasi-public agency of the Commonwealth of Massachusetts tasked with implementing the Massachusetts Life Sciences Act, a ten-year, $1 billion initiative that was signed into law in June of 2008. The Center's mission is to create jobs in the life sciences and support vital scientific research that will improve the human condition. This work includes making financial investments in public and private institutions that are advancing life sciences research, development and commercialization as well as building ties among sectors of the Massachusetts life sciences community.
For more information, visit www.masslifesciences.com
Appendix A
Polysialylated blood coagulation factors
The Company has a broad exclusive license with Baxter International Inc. for drugs focused on the treatment of haemophilia A, B and for patients with inhibitors. Currently drugs nominated for development under this license include FVIII, FIX and inhibitors.
ErepoXen® (Polysialylated Erythropoietin)
ErepoXen® is a long-acting erythropoietin ("EPO") product candidate from Xenetic which offers three key benefits:
1. Reduction in the frequency of dosage;
2. Reduction in immunogenicity; and
3. Reduction in toxicity.
ErepoXen® is currently in Phase II(b) clinical development in collaboration with our partner, the Serum Institute of India and the Company has selected this product to be its lead candidate for FDA/EMA clinical trials expected to commence in Q1-2013.
OncoHist® (Recombinant human Histone H1.3)
OncoHist® is a novel bio-therapeutic molecule for the treatment of haematologic malignancies..  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. This molecule has the potential to be a blockbuster candidate as a non-toxic therapy for deadly cancers and will be the second clinical candidate to enter FDA trials with a planned commencement in Q2-2013.
SuliXen® (Polysialylated Insulin)
SuliXen® is a proprietary human insulin 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 is also on track to commence a Phase I trial for a CNS (central nervous system) indication.
Baxter International Inc
In 2006, the Company entered into a US$75 million license agreement with Baxter International Inc ("Baxter") 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 resulting in the selection of a lead candidate, providing confidence in the program's potential to transition into clinical development.  This novel polysialyated Factor VIII candidate is expected to enter Western clinical trials in H1-2013.  Baxter is also a leading shareholder in the Company
Serum Institute of India ("Serum"/"SIIL")
Serum is one of the world's largest vaccine manufacturing companies, with two of every three paediatric vaccines administered in the world being a Serum product.  It is India's biggest biotech companies and is Xenetic's key collaborator on two important programs, being, first (and most important), as currently, the sole producer to cGMP standards of PSA (polysialic acid) the core component of the Company's PolyXen® technology, and, secondly, as the co-developer of the ErepoXen® product candidate now in Phase II(b) clinical trials. Serum is the Company's second largest shareholder.
SynBio LLC ("SYN")
SYN is an SPV established in Moscow by the merger of the commercial skill sets of two of Russia's only publicly-traded biotech corporations (Pharmsynthez and Human Stem Cell Institute) with around US$50 million of new equity capital provided by RUSNANO, a $5bln sovereign fund founded in March 2011.   In late-November 2011 SYN invested ~US$20m in XEN, and currently holds  approx.. 45% of the Company's equity.  Alongside this equity investment, SYN and XEN entered into a Co-Development Agreement ("CDA") whereby SYN, will seek to develop up to six novel drug  candidates for the Russian market.  While SYN has exclusive development rights over such products for Russia and the former CIS territories, XEN, based on product trial results and analytics, will be well-positioned to make an informed commercial decision to enter any such product into Western trials with a view to future product launches across all otherworld markets.
Out-licensing all of the Company's technologies to SYN for application on a broad range of products is aimed, inter alia, at providing XEN with a reliable flow of data and, ultimately, new product candidates, on a substantially risk-reduced basis – a characteristic not normally associated with the life sciences sector.
Pharmsynthez ("PSZ")
Xenetic and PSZ entered into a six-product CDA in late 2009 on clinical and exploitation terms which were closely reflected in the transaction with SYN (ante).  This deal established the foundation of the Company's early-stage product development strategy and is expected to yield at least two additional clinical programs in 2012.  PSZ is one of the only two current publicly-traded Russian biotech companies.


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