Universal influenza vaccine moves a step closer

London-based PepTCell, trading as SEEK, is partnering the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), to jointly lead a study¹ to evaluate the efficacy and safety of SEEK’s universal flu candidate, FLU-v.

FLU-v is a peptide-based vaccine that stimulates a cytotoxic T lymphocyte and non-neutralising antibody response against influenza. SEKK says it may have potential as a cross-protective vaccine for multiple strains of influenza.

Clinical studies will be performed in a NIAID influenza human challenge model where patients are first provided with the trial medication and then ‘challenged’ with a known pathogen.

The announcement of the NIAID collaboration and the US-based trial follows the low efficacy of last year’s annual influenza vaccine. The vaccine was not as effective as required, preventing only 23 out of every 100 vaccinated people from developing flu symptoms.² Existing antivirals (oseltamivir and zanamivir), intended to be used in infected patients, have also been shown to be of insufficient effectiveness in reducing the burden of influenza.³

Flu kills between 250,000 to 500,000 people globally every year.⁴ In 2014, the influenza virus mutated resulting in the annual influenza vaccine, given to many thousands of people, being relatively ineffective. The annual vaccine has to be recreated and approved each year as the new season’s influenza virus strains emerge. These newly formulated vaccines can result in poor levels of protection when the vaccinated strains are mismatched (as they were during the 2014-15 season).

Gregory Stoloff, Chief Executive of SEEK commented: 'Following successful Phase I and II human trials in the UK, the current on-going Phase IIb study in Europe and this newly announced challenge study in the US, in collaboration with the NIH, we will have a very strong data package to support our applications for licences for FLU-v.

'Given the desperate need for effective products in this area, favourable results from these studies could enable breakthrough status or fast track approval being granted to this product as well as funding support from Government backed programmes.'

References

1. Phase II Study of the Efficacy and Safety of FLU-v, PepTCell Limited’s Proprietary Peptide-Based Universal Influenza Vaccine Containing Conserved T Cell Epitopes in the National Institute of Allergy and Infectious Diseases’ Influenza Human Challenge Model.

2. Flannery, B et al Early Estimates of Seasonal Influenza Vaccine Effectiveness — United States, January 2015 Morbidity and Mortality Weekly Report (MMWR), Centers for Disease Control and Prevention (last accessed September 2015)

3. Cochrane Community. Tamiflu and Relenza: getting the full evidence picture http://community.cochrane.org/features/tamiflu-and-relenza-getting-full-evidence-picture (last accessed July 2015)

4. World Health Organisation (WHO), Media Centre, Fact sheets, Influenza – seasonal  http://www.who.int/mediacentre/factsheets/fs211/en/ (last accessed July 2015)