Akston Biosciences has entered into a strategic partnership with US-based contract research, development, and manufacturing organisation (CRDMO) LakePharma to manufacture second-generation Covid-19 vaccine.
Under the deal, LakePharma will produce Akston’s adjuvanted Covid-19 vaccine candidate (AKS-452), which is slated to start phase 1/2 clinical testing later this month.
LakePharma president and CEO Dr Hua Tu said: “LakePharma started working on various Covid-19 activities in February 2020, and was among the first companies to provide a set of recombinantly-produced SARS-CoV-2 spike proteins for diagnostic and therapeutic development.”
AKS-452 is claimed to be the most advanced Covid-19-specific Fc fusion protein vaccine under development.
The vaccine candidate has been designed to induce or accelerate a Th1/Th2 mixed immune response in patients against the Receptor Binding Domain (RBD) of the novel SARS-CoV-2 coronavirus spike protein.
The inherent nature of the vaccine candidate’s construct is said to provide a unique combination of benefits compared to nucleic acid, viral-vectored, and inactivated virus vaccines.
AKS-452 has been demonstrated to be shelf-stable for weeks at up to 37 °C (95°F) compared to other vaccines must be kept refrigerated or even deep-frozen for transport and storage, said the company.
Akston has designed AKS-452 to use conventional antibody manufacturing techniques. With multiple batches over one year, a single 2,000-liter production train holds the capacity to produce more than one billion doses.
Akston Biosciences president and CEO Todd Zion said: “Our team realized early on that our fusion protein platform could be used to design a vaccine that checked all the boxes – transportable at ambient temperatures, produced at very low cost, and suitable for repeated dosing if immunity wanes.
“Partnering with LakePharma gives us great confidence that we can ramp up quickly to deliver large quantities of AKS-452 on a commercial basis.”
In September 2020, Johnson & Johnson (J&J) company Janssen Pharmaceuticals partnered with injectable contract development and manufacturing organisation (CDMO) Grand River Aseptic Manufacturing (GRAM) to produce its SARS-CoV-2 vaccine candidate.