Policy & Regulation
Akston Biosciences partners with LakePharma to manufacture second-generation COVID-19 vaccine, AKS-452
6 January 2021 -

Biotechnology CRDMO company LakePharma stated on Tuesday that it will manufacture the commercial quantities of Akston's adjuvated COVID-19 vaccine candidate (AKS-452) that is scheduled to begin Phase 1/2 clinical testing later this month under a strategic partnership with Akston Biosciences.

Akston's AKS-452 is reportedly the most advanced COVID-19-specific Fc fusion protein vaccine in commercial development and is engineered to induce or boost a Th1/Th2 mixed immune response in patients against the Receptor Binding Domain (RBD) of the novel SARS-CoV-2 coronavirus spike protein.

Compared to other vaccines that must be kept refrigerated or even deep-frozen for transport and storage, Akston's AKS-452 has been shown to be shelf-stable for weeks at up to 37 degrees Celsius (95°F). This greatly simplifies distribution and is critically important for vaccinating the billions of people not served by sophisticated and costly cold-chain transportation.

In conjunction, Akston's conventional antibody manufacturing techniques in multiple batches over one year would result in a single 2,000-liter production train would be capable of producing over 1bn doses of AKS-452. AKS-452 is stable for weeks at room temperature, inexpensive to produce and suitable for both first-time and booster vaccination