As a vaccine that is shelf-stable for weeks at up to 37˚ C (95˚ F), the candidate does not require complicated or expensive storage and transportation. It is also inexpensive to produce - a single facility could produce up to 1 billion doses a year, according to company estimates - and would also be suitable for repeated dosing if immunity fades.
The adjuvanted COVID-19 vaccine candidate, AKS-452, is the most advanced COVID-19 specific Fc fusion protein vaccine in commercial development.
From insulin to vaccines
Based in Massachusetts, Akston Biosciences’ focus is on designing novel fusion proteins to develop and manufacture new classes of biologic therapeutics for Type 1 diabetes prevention, ultra-long acting insulin therapy, and vaccines. It was founded in 2011 by the team that developed the world’s first clinical glucose-responsive insulin at SmartCells (which was sold to Merck & Co in 2010).
The company already considers itself a leader in the field of insulin engineering but is pivoting efforts toward the COVID-19 vaccine.
"We already had the technology so our work with insulin engineering allowed us to jumpstart development of a COVID-19 vaccine," Todd Zion, CEO, Akston, told this publication. "That said, since we are a data-driven culture first and foremost, we waited to collect all the necessary data, develop the necessary manufacturing, quality control systems, etc. before asking for other people’s money.
"While we continue to make progress on our insulin platform, the pandemic is too consequential to ignore: especially since the benefits of our platform, like shelf-stability in room temperature and the ability to provide repeated dosages, is an important long-term advantage to deliver a vaccine to everyone and everywhere."
Its COVID-19 vaccine has been 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. Preclinical animal studies have shown robust, neutralizing antibody production at microgram doses.
Akston says it realized early on in the pandemic that its fusion protein platform could be used to design a vaccine at low cost. And without the need for refrigerated or freezer storage, the candidate could be used to reach billions of people not served by sophisticated and costly cold-chain transportation.
Akston has engineered AKS-452 to use conventional antibody manufacturing techniques, such that with multiple batches over one year, a single 2,000-liter production train would be capable of producing over one billion doses.
Furthermore, Zion believes that the technology will be able to be transfered to other vaccine candidates in the future: building on the company's history of studying immune responses to difference Fc-fusion candidates.
Phase 3 readouts could come in April
Akston is working to fast-track the development and clinical evaluation of AKS-452. Announced today, the strategic partnership with LakePharma (a US-based Biologics CRDMO with operations in CA, TX, and MA) will produce drug substance for the Phase 3 clinical trial as well as large-scale commercial manufacturing.
Akston has produced the drug substance for the GLP safety and toxicology studies and the Phase 1 and Phase 2 clinical studies in its own GMP manufacturing facility in Beverly, MA.
Meanwhile, a partnership with TRACER Europe B.V. will support the Phase 1 and 2 clinical trials in the Netherlands. TRACER is providing regulatory services, oversight of the local manufacturing contractor that filled and finished the clinical batches, as well as study preparation and clinical site management.
Authorization of the vaccine could happen as soon as April if the vaccine completes trials successfully and to schedule.
"Phase 1 will start in mid-January followed by Phase 2 in late February and Phase 3 in late March/early April," said Zion. "We would like to apply for an emergency use authorization in Europe as soon as the first Phase 3 readouts are available in April/May. We are pursuing a parallel path in the US, albeit at a slight delay."