The Future of the Global Infectious Disease Booster Market

Vakston is creating novel responses to infectious diseases and is committed to bringing vaccines to patients across the world. Vakston leverages its first-in-class Ambifect® Fc-fusion platform to provide accessible, durable vaccines and boosters that improve human health.

AKS-452 Vaccine Study Published in Nature, Showcasing Ambifect® Platform’s Versatility

This Netherlands study showed the ability of a 90 ug subcutaneous dose to safely boost the immune response of individuals previously primed with a registered mRNA- or adenovirus-based SARS-CoV-2 vaccine.

Ambifect® Vaccine Fc-fusion Platform Advantages

The Ambifect® Fc-fusion Platform has the capability to spearhead the next generation of globally accessible vaccines due to its disruptive competitive advantages:

  • Lowest cost – pennies per dose to manufacture
  • Reduced development time and cost
  • No cold chain restrictions – shelf stable for > 6 months
  • Versatile and customizable – enables pipeline expansion in therapeutic vaccines
  • First-in-class tolerance and efficacy
  • Self-adjuvanted
  • Best-in-class booster across new variants, long-lasting durable neutralizing immune response

 

Current pipeline indications in development or under consideration include: COVID-19, RSV, MERS, Multivalent URTls, Infectious Diseases.

Ambifect® Vaccine Fc-fusion Platform Case Study: AKS-452 (COVID-19)

AKS-452 is a CoV-2 protein subunit vaccine based on the Ambifect® Fc-fusion protein platform. This vaccine is thermostable, low-cost, and has a ‘universal’ booster vaccine capability.

 

 

The vaccine is designed to meet the specific needs of developing countries – low-cost production and little or no refrigeration needed for transport and use.

AKS-452 has been shown to be shelf-­stable for at least six months at 25° Celsius (77° Fahrenheit) and maintains its potency for one month at 37° Celsius (99° Fahrenheit). This can greatly simplify distribution and is critically important for vaccinating the billions of people not served by current vaccines needing costly cold-chain transportation.

AKS-452 is ready for commercialization, turnkey in CMC and regulatory

The AKS-452 COVID-19 vaccine provides a practical solution to the problem of vaccinating and boosting SARS-CoV-2 immunity for people all over the world.

Primary: Phase I-III clinical results demonstrated safety and efficacy. Phase I/II clinical trials in Europe showed >90% seroconversion and neutralization across variants. Similar seroconversion in Phase I/II trials in India with superior safety and efficacy compared to Covishield and Covaxin especially against variants of concern.

Booster: Phase II clinical results demonstrated significant boosting against variants. 4x and 5x mean-fold increase against the Wuhan and Omincron strains. 93% of subjects previously vaccinated with Pfizer, Moderna, JNJ, and AZ vaccines showed an increase in neutralizing antibody titers.

 

Transportable without cold-chain:

Shelf-stable for over six months at 25° Celsius (77° Fahrenheit)

Maintains potency for one month at 37° Celsius (99° Fahrenheit)

High volume, low cost manufacturing:

Uses established antibody production infrastructure

Single production line can make over one billion doses per year

First-in-human Fc-fusion vaccine shown to be safe and effective in EU and India clinkat trials

Does not include mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus

Focused presentation of Receptor Binding Domain (RBD)

Designed to preserve effectiveness against viral variants

Suitable for boosting immune response of those vaccinated or recovered from infection

For more information about partnering with Vakston, contact:
Gary Magnant, Interim CEO/Venture Engineer: gary.magnant@vakston.com +1-617-592-1660