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Singapore's First Influenza Vaccines Demonstrates Favorable Immunogenicity and Tolerability in Clinical Testing

SINGAPORE and ZURICH, January 29, 2014 /PRNewswire/ --

Singapore's Agency for Science, Technology and Research (A*STAR) and Switzerland's Cytos Biotechnology AG today announced that their influenza vaccine (gH1-Qbeta) met its primary end point for immunogenicity (seroconversion based on haemaglutination inhibition titres according to FDA criteria) in the Phase 1 clinical trial in healthy Asian volunteers. The induced immune response showed good cross-reactivity to recent drifted H1N1 strains.  The H1N1 influenza vaccine candidate is based on Cytos' proprietary bacteriophage Qbeta virus-like particle (VLP) technology.

The clinical trial, commenced in May 2013[1] and completed enrollment and treatment of all 84 healthy volunteers in August 2013. During this trial the volunteers received two injections of the vaccine, 21 days apart. A*STAR and Cytos are pleased to announce that the vaccine was safe and well tolerated No serious adverse events were reported during the trial. The induced immune responses were comparable to that of approved seasonal influenza vaccines.  

A*STAR is developing the vaccine candidate under a collaborative research, development and commercialization agreement entered into with Cytos in 2010[2], with the goal of providing the government of Singapore effective means of combatting influenza epidemics and pandemics. Under the agreement, Cytos retains the worldwide right to develop and commercialize the vaccine candidate globally, while A*STAR subsidiaries have the right to develop and commercialize the vaccine for Singapore and other ASEAN countries and can earn royalties on worldwide net sales.

Christian Itin, PhD, Chairman and Chief Executive Officer of Cytos, commented, "We are encouraged to see seroconversion in patients treated with our bacterially derived recombinant flu vaccine and are evaluating next steps with our partner A*STAR. The results of this study further support the utility of our VLP vaccine platform for the treatment of infectious diseases."

Professor Alex Matter, Chief Executive Officer of D3 (Drug Discovery and Development) and A*STAR's Experimental Therapeutics Centre (ETC) said, "We are very pleased with the outcome of this trial. The favourable data demonstrates that the VLP-vaccine strategy is an effective one. We are now planning, in conjunction with Cytos, the next steps for this project."

A*STAR's Experimental Therapeutics Centre (ETC) was the primary driver of the multi-institutional effort culminating in the start of the clinical development program, which involved academic and clinical partners across Singapore, namely A*STAR's IMCB A*STAR Program in Translational Research on Infectious Diseases and Bioinformatics Institute (BII), DSO National Laboratories and Duke-NUS Graduate Medical School. Since early 2012, D3, which works hand in hand with Cytos and with other local entities, has been leading the development of the H1N1 influenza vaccine project aiming to achieve proof-of-concept in humans. The clinical part of the Phase 1 trial was conducted at the SingHealth Investigational Medicine Unit and the Changi General Hospital Clinical Trial Research Unit in Singapore.

Full results have been submitted for publication in a peer reviewed journal. Preclinical proof-of-concept for this vaccine was recently published in PLoS One (Skibinski, DA et al, PLoS One. 2013 Oct 18;8(10):e76571 and Jegerlehner, A et al, PLoS One. 2013 Nov 18;8(11):e78947).

About Influenza Infection and Vaccination

According to the World Health Organisation, it is estimated that 10 to 20 percent of the world's population are infected during seasonal influenza epidemic, causing three to five million people to be seriously ill, and killing 250,000 to 500,000 each year[3]. One of the most effective ways to significantly reduce the incidence of death and serious illness from influenza is through vaccination. In the case of a pandemic, it is vital to be able to produce vaccines quickly and in large quantities to be able to vaccinate the majority of the population prior to the spreading of the pandemic influenza strain. The conventional way to produce influenza vaccine using chicken eggs has limited yields, is time consuming and sometimes constrained due to the toxicity of certain viral strains to birds (e.g. H5N1 bird flu virus). Growing the virus in cell cultures may get around strain toxicity, however the yields are also modest, the processing of the viruses remains the same and the production cost are very high.

About the Influenza Vaccine Developed By A*STAR and Cytos

Cytos' proprietary technology used for this vaccine overcomes the shortcomings of conventional vaccines since both components can be produced recombinantly with high yields in E. coli. The vaccine consist of Cytos' clinically validated Qbeta VLP as an immunological carrier conjugated with the globular head domain of hemagglutinin (HA) which is displayed in repetitive, ordered fashion on the surface of the VLP. In the resulting non-infectious vaccine, the influenza antigen derived from the surface protein HA is presented in a highly immunogenic manner to the immune system.

About the Agency for Science, Technology and Research (A*STAR)

The Agency for Science, Technology and Research (A*STAR) is Singapore's lead public sector agency that fosters world-class scientific research and talent to drive economic growth and transform Singapore into a vibrant knowledge-based and innovation driven economy. In line with its mission-oriented mandate, A*STAR spearheads research and development in fields that are essential to growing Singapore's manufacturing sector and catalysing new growth industries. A*STAR supports these economic clusters by providing intellectual, human and industrial capital to its partners in industry.

A*STAR oversees 20 biomedical sciences and physical sciences and engineering research entities, located in Biopolis and Fusionopolis as well as their vicinity. These two R&D hubs house a bustling and diverse community of local and international research scientists and engineers from A*STAR's research entities as well as a growing number of corporate laboratories.

For more information about A*STAR, please visit http://www.a-star.edu.sg

About D3

D3 (Drug Discovery and Development) was established in 2012 to build strong bridges between basic science and clinical research and development by bringing early-stage scientific discoveries to 'proof-of-concept' clinical trials in humans and generating economic benefit through the licensing of clinical stage therapeutics.  D3 builds on Singapore's existing drug discovery capabilities and strengthens the local biomedical innovation landscape. It was founded to be a cost-effective and professional development partner able to advance and add value to early-stage projects on a 'shared-risk, shared-reward' basis.  D3's primary focus is on developing drugs targeted at oncology indications and infectious diseases but the door is open to other indications if a partner brings the necessary disease knowledge. D3 is jointly funded by A*STAR, the Ministry of Health's National Medical Research Council and the National Research Foundation. For more information about D3, please visit http://www.d3.a-star.edu.sg

About Cytos Biotechnology Ltd

Cytos is a public biopharmaceutical company focused on the development of targeted immuno-therapies. The Company's lead product candidate CYT003 is a novel, first-in-class, immune modulator in Phase 2 clinical development as a potential new treatment for asthma.

CYT003 has a novel mechanism of action that inhibits the immune response that causes asthma, and may therefore be beneficial for the control of asthma. In a successfully completed Phase 2a study, CYT003 was shown to maintain asthma control and lung function in patients with persistent allergic asthma, despite withdrawal of standard therapy with inhaled corticosteroids.

CYT003 has been shown to have a good safety and tolerability profile in more than 450 individuals receiving the active agent so far. Cytos was founded in 1995 as a spinoff from the Swiss Federal Institute of Technology (ETH) in Zurich. It is located in Schlieren (Zurich), Switzerland. The Company is listed according to the Main Standard on the SIX Swiss Exchange Ltd under the symbol CYTN.

http://www.cytos.com

Forward Looking Statements
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements.  You are urged to consider statements that include the words "will" or "expect" or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, including that CYT003 may not demonstrate safety or efficacy in clinical trials, that there may be delays in development or that CYT003 may not receive marketing approval, and that the Company relies on outside financing to meet capital requirements, which may not be available under acceptable terms or at all. Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

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1. http://www.a-star.edu.sg/Media/News/Press-Releases/ID/1821/Default.aspx

2. http://www.a-star.edu.sg/Portals/0/media/Press%20Release/20100715_ASTAR-Cytos%20flu%20vaccine.pdf

3. Monto, A.S. (2008). Epidemiology of influenza, Vaccine 26 Suppl 4, D45-48

SOURCE Cytos Biotechnology

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