Cytos Biotechnology AG

DGAP-Adhoc: Cytos Biotechnology Ltd: Singapore's first influenza vaccine demonstrates favourable immunogenicity and tolerability

Cytos Biotechnology AG  / Key word(s): Research Update/Study

29.01.2014 07:00

Release of an ad hoc announcement pursuant to Art. 53 KR
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Joint Media Release

SINGAPORE'S FIRST INFLUENZA VACCINES DEMONSTRATES FAVOURABLE IMMUNOGENICITY
AND TOLERABILITY IN CLINICAL TESTING

Singapore and Schlieren (Zurich), Switzerland, January 29, 2014 -
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.'

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

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).

For further information, please contact:

Agency for Science, Technology and Research (A*STAR)
Mui Ching Han
Tel: (65) 6826 6442
Email: HAN_Mui_Ching@a-star.edu.sg

Cytos Biotechnology AG
Harry Welten
Chief Financial Officer
Tel: +41 44 733 46 46
e-mail: harry.welten@cytos.com

US Investor enquiries
Susan A. Noonan
Tel: +1 (212) 966 3650
e-mail: susan@sanoonan.com

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 . 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 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 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.

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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Document: http://n.equitystory.com/c/fncls.ssp?u=WOESGVNXNM
Document title: Cytos_Press_E_140129


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Language:               English
Company:                Cytos Biotechnology AG
                        Wagistr. 25
                        8952 Schlieren
                        Switzerland
Phone:                  +41 44 733 4747
Fax:                    +41 44 733 4740
E-mail:              info@cytos.com
Internet:            www.cytos.com
ISIN:                   CH0011025217, CH0029060735
Valor:                  -
Listed:                 Freiverkehr in Berlin, München, Stuttgart;
                        Frankfurt in Open Market ; SIX

End of Announcement                             EQS Group News-Service

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