The Phase I/II clinical testing of the vaccine candidate is set to commence this month. Credit: Getty Images

Akston Biosciences has established a strategic partnership with US-based Biologics CRDMO LakePharma to manufacture second-generation Covid-19 vaccine.

Under the partnership, LakePharma will manufacture Akston’s adjuvanted Covid-19 vaccine candidate, AKS-452.

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The Phase I / II clinical testing of the vaccine candidate should commence this month.

AKS-452 is engineered to stimulate a Th1 / Th2 mixed immune response in individuals against the Receptor Binding Domain (RBD) of the spike protein of SARS-CoV-2 virus.

Compared to vaccines, which need refrigeration or deep-freezing for transport and storage, the vaccine candidate proved shelf-stable for weeks at room temperature of up to 37°C (95°F).

This will aid in easing the distribution process and is vital for inoculating the billions of people without needing complicated and expensive cold-chain transportation.

Akston Biosciences president and CEO Todd Zion said: “Our team realised 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.”

Akston engineered the vaccine to utilise conventional antibody manufacturing methods in a way that a single 2,000l production train can potentially make more than one billion doses in multiple batches over a year.

LakePharma president and CEO Hua Tu said: “We bring three critical components to this partnership: our experience in making SARS-CoV-2 proteins, our stable CHO-GSN technology, and most importantly, the use of the cGMP manufacturing suite in our Hopkinton, MA facility.

“We have worked with Akston and its fusion protein therapeutics since 2015, and this experience means we can transition AKS-452 into large-scale production very rapidly.”