Singapore's Agency for Science, Technology and Research (A*STAR) and Switzerland's Cytos Biotechnology have 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 I 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, completed enrollment and treatment of all 84 healthy volunteers in Aug. 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 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 effective means of combatting influenza epidemics and pandemics. 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, Ph.D., chairman and CEO of Cytos, said, "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, CEO of D3 (Drug Discovery and Development) and A*STAR's Experimental Therapeutics Center (ETC) said, "We are very pleased with the outcome of this trial. The favorable 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 I trial was conducted at the SingHealth Investigational Medicine Unit and the Changi General Hospital Clinical Trial Research Unit in Singapore.