Date: 2014-01-29
Type of information:
phase: 1
Announcement: results
Company: Agency for Science, Technology and Research (A*STAR) (Singapore) Cytos Biotechnology (Switzerland)
Product: gH1-Qbeta - H1N1 influenza vaccine candidate based on Cytos’ proprietary bacteriophage Qbeta virus-like particle (VLP) technology
Action mechanism: The H1N1 influenza vaccine candidate is based on Cytos’ proprietary bacteriophage Qbeta virus-like particle (VLP) technology.This proprietary technology overcomes the short comings of conventional vaccines since all components can be produced recombinantly at high levels in E.coli. The vaccine encompasses on the one hand Cytos’ clinically validated Qbeta VLP as an immunological carrier and on the other hand the globular domain of hemagglutinin (HA) which is displayed 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.
Disease: H1N1 influenza infection
Therapeutic area: Infectious diseases
Country: Singapore
Trial details: 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.
Latest
news: * On January 29, 2014, Singapore’s Agency for Science, Technology and Research (A*STAR) and Cytos Biotechnology have announced that their influenza vaccine (gH1-Qbeta) met its primary end point for immunogenicity in the Phase 1 clinical trial in healthy Asian volunteers. The induced immune response showed good cross-reactivity to recent drifted H1N1 strains. The clinical trial, commenced in May 2013 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. 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 now planning, in conjunction with Cytos, the next steps for this project. 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).A*STAR is developing the vaccine candidate under a collaborative research, development and commercialization agreement entered into with Cytos in 20102, 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.* On May 17, 2013, Singapore’s Agency for Science, Technology and Research (A*STAR) and Switzerland’s Cytos Biotechnology have announced that the first healthy volunteer has been dosed in a Phase 1 clinical trial with their H1N1 influenza vaccine candidate based on Cytos’ proprietary bacteriophage Qbeta virus-like particle (VLP) technology. In this first Phase 1 clinical trial, the safety and immunogenicity of this novel vaccine candidate and its potential to protect against H1N1 influenza infection will be evaluated. A*STAR is developing the vaccine candidate under a collaborative research, development and commercialization agreement entered into with Cytos in 2010, with the goal of providing the government of Singapore an 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 will have the right to develop and commercialize the vaccine for Singapore and other ASEAN countries and can earn royalties on worldwide net sales. This Phase 1 clinical trial is being conducted at the SingHealth Investigational Medicine Unit and the Changi General Hospital Trials and Research unit in Singapore.
