The biotech is looking to progress its fully synthetic CD8+ T cell adaptive vaccine and announced that it had begun current good manufacturing practice (cGMP) production of the vaccine candidate.
Emergex stated that its vaccine works differently to traditional influenza vaccines, by priming influenza-specific CD8+ T cells that are able to recognize the same peptides when presented on the surface of infected cells, killing them during the eclipse phase and preventing virion production.
According to the biotech, this approach has the potential to supplant the conventional strategy of developing strain-specific vaccines and instead could offer extended, broad immune protection, as well as protection against future pandemic strains of the influenza virus.
In terms of the manufacturing capacity Emergex possesses, a spokesperson for the company told BioPharma-Reporter, “Emergex is in the process of integrating its own GMP manufacturing facility, which will accommodate capacity requirements for Phase I and II clinical trials.”
The spokesperson added that, due to the synthetic nature of the vaccine, which does not contain any biological matter, the process of scaling up capacity further is ‘easily feasibly’ and the manufacturing process itself is simple.
The company recently signed an agreement with the Molecular Biology Institute of Paraná (IBMP) in Brazil, which will involve the UK biotech sharing clinical development with the Institute for the development of Dengue, COVID-19 and Chikungunya vaccines. Should research prove fruitful, the IBMP will claim the exclusive rights for the commercialization of the vaccines in Brazil.
Currently, Emergex's Dengue vaccine is its most advanced vaccine candidate, as it progresses through Phase I trials in Switzerland, with results expected soon.
On the announcement of the commencement of manufacture of its universal flu vaccine, Emergex stated that trials into its Dengue and COVID-19 vaccine “have demonstrated…the platform potential of the vaccine platform in humans.”
Targeting the flu
In the announcement regarding the influenza vaccine candidate’s production starting, Emergex highlighted that the motivation behind development was due to the vaccine’s potential to protect both from seasonal flu and future pandemics.
The World Health Organization estimates that the flu kills 290,000 to 650,000 worldwide per year. As a result, an effective universal flu vaccine could have a huge impact. In addition, the influenza virus is a pandemic risk, with the virus causing ‘recurring’ and ‘unpredictable’ pandemics, according to a recent study.
The spokesperson for Emergex outlined why it had pursued its particular vaccine approach: “There are many potential benefits to developing a vaccine that induces a T cell response including the possibility of generating longer lasting immunity. Emergex’s vaccines are also designed to be universal as it targets highly conserved proteins that are conserved across seasonal flu strains potential novel pandemic strains.”