Welcome!

News Feed Item

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.

--------------------------------------------------

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

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Most companies are adopting or evaluating container technology - Docker in particular - to speed up application deployment, drive down cost, ease management and make application delivery more flexible overall. As with most new architectures, this dream takes a lot of work to become a reality. Even when you do get your application componentized enough and packaged properly, there are still challenges for DevOps teams to making the shift to continuous delivery and achieving that reduction in cost ...
The explosion of new web/cloud/IoT-based applications and the data they generate are transforming our world right before our eyes. In this rush to adopt these new technologies, organizations are often ignoring fundamental questions concerning who owns the data and failing to ask for permission to conduct invasive surveillance of their customers. Organizations that are not transparent about how their systems gather data telemetry without offering shared data ownership risk product rejection, regu...
Translating agile methodology into real-world best practices within the modern software factory has driven widespread DevOps adoption, yet much work remains to expand workflows and tooling across the enterprise. As models evolve from pockets of experimentation into wholescale organizational reinvention, practitioners find themselves challenged to incorporate the culture and architecture necessary to support DevOps at scale. In his session at @DevOpsSummit at 20th Cloud Expo, Anand Akela, Senior...
In his keynote at 19th Cloud Expo, Sheng Liang, co-founder and CEO of Rancher Labs, discussed the technological advances and new business opportunities created by the rapid adoption of containers. With the success of Amazon Web Services (AWS) and various open source technologies used to build private clouds, cloud computing has become an essential component of IT strategy. However, users continue to face challenges in implementing clouds, as older technologies evolve and newer ones like Docker c...
SYS-CON Events announced today that Twistlock, the leading provider of cloud container security solutions, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Twistlock is the industry's first enterprise security suite for container security. Twistlock's technology addresses risks on the host and within the application of the container, enabling enterprises to consistently enforce security policies, monitor...
The Internet of Things is clearly many things: data collection and analytics, wearables, Smart Grids and Smart Cities, the Industrial Internet, and more. Cool platforms like Arduino, Raspberry Pi, Intel's Galileo and Edison, and a diverse world of sensors are making the IoT a great toy box for developers in all these areas. In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists discussed what things are the most important, which will have the most profound e...
Automation is enabling enterprises to design, deploy, and manage more complex, hybrid cloud environments. Yet the people who manage these environments must be trained in and understanding these environments better than ever before. A new era of analytics and cognitive computing is adding intelligence, but also more complexity, to these cloud environments. How smart is your cloud? How smart should it be? In this power panel at 20th Cloud Expo, moderated by Conference Chair Roger Strukhoff, pane...
The goal of Continuous Testing is to shift testing left to find defects earlier and release software faster. This can be achieved by integrating a set of open source functional and performance testing tools in the early stages of your software delivery lifecycle. There is one process that binds all application delivery stages together into one well-orchestrated machine: Continuous Testing. Continuous Testing is the conveyor belt between the Software Factory and production stages. Artifacts are ...
Blockchain is a shared, secure record of exchange that establishes trust, accountability and transparency across supply chain networks. Supported by the Linux Foundation's open source, open-standards based Hyperledger Project, Blockchain has the potential to improve regulatory compliance, reduce cost and time for product recall as well as advance trade. Are you curious about Blockchain and how it can provide you with new opportunities for innovation and growth? In her session at 20th Cloud Exp...
@ThingsExpo has been named the Most Influential ‘Smart Cities - IIoT' Account and @BigDataExpo has been named fourteenth by Right Relevance (RR), which provides curated information and intelligence on approximately 50,000 topics. In addition, Right Relevance provides an Insights offering that combines the above Topics and Influencers information with real time conversations to provide actionable intelligence with visualizations to enable decision making. The Insights service is applicable to eve...
SYS-CON Events announced today that Grape Up will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct. 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Grape Up is a software company specializing in cloud native application development and professional services related to Cloud Foundry PaaS. With five expert teams that operate in various sectors of the market across the U.S. and Europe, Grape Up works with a variety of customers from emergi...
SYS-CON Events announced today that Hitachi, the leading provider the Internet of Things and Digital Transformation, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Hitachi Data Systems, a wholly owned subsidiary of Hitachi, Ltd., offers an integrated portfolio of services and solutions that enable digital transformation through enhanced data management, governance, mobility and analytics. We help globa...
SYS-CON Events announced today that Juniper Networks (NYSE: JNPR), an industry leader in automated, scalable and secure networks, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Juniper Networks challenges the status quo with products, solutions and services that transform the economics of networking. The company co-innovates with customers and partners to deliver automated, scalable and secure network...
Developers want to create better apps faster. Static clouds are giving way to scalable systems, with dynamic resource allocation and application monitoring. You won't hear that chant from users on any picket line, but helping developers to create better apps faster is the mission of Lee Atchison, principal cloud architect and advocate at New Relic Inc., based in San Francisco. His singular job is to understand and drive the industry in the areas of cloud architecture, microservices, scalability ...
SYS-CON Events announced today that CA Technologies has been named "Platinum Sponsor" of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, New York, and 21st International Cloud Expo, which will take place in November in Silicon Valley, California.