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

January 29, 2014

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


Source: PR Newswire



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