Policy & Regulation
Akston Biosciences Inks Commercial Supply Agreement of Seppic's Adjuvant to Formulate Akston Shelf-Stable COVID-19 Vaccine at Global Scale
21 July 2021 - - US-based biologic therapeutics developer Akston Biosciences Corp has inked a commercial agreement with France-based specialty healthcare ingredients supplier Seppic S.A., for the supply of adjuvant for use in Akston's COVID-19 Fc fusion protein vaccine candidate, AKS-452, the company said.

Seppic will provide Montanide ISA 720 VG adjuvant for use in the vaccine, and is working with Akston to produce 10 m doses of adjuvant by late 2021 and up to 100m doses per month in 2022.

The two companies began collaborating for the development of AKS-452 in the summer of 2020.

AKS-452 is a protein subunit vaccine that is in Phase II testing at the University Medical Center Groningen, one of the largest hospitals in the Netherlands.

It has been shown to be shelf-stable for at least six months at 25 degrees Celsius (77 degrees Fahrenheit) and it maintains its potency for one month at 37 degrees Celsius (99 degrees Fahrenheit).

Seppic has already started the ramp-up of its adjuvant, in one of its manufacturing facilities in France, to be ready for significant demand.

Based on Akston's proprietary Fc fusion protein platform, AKS-452 is a CoV-2 protein subunit vaccine designed to induce a Th1/Th2 mixed immune response in patients against the Receptor Binding Domain of the novel coronavirus spike protein.

Being the primary locus for infection, the RBD is highly conserved among mutated forms of the virus, and preclinical studies have demonstrated robust antibody neutralization of the B.1.1.7 and B.1.351 variants.

The vaccine has been engineered to use standard, low-cost, antibody manufacturing techniques, such that a single production line could be capable of producing over one bn doses per year.

Seppic, an Air Liquide Healthcare company, designs, produces, and distributes for more than 75 years a wide range of specialty ingredients for health and beauty.

Present in 100 countries through its subsidiaries and its network of distributors, Seppic employs more than 820 people worldwide, including 110 employees dedicated to innovation. 

Akston Biosciences Corp. leverages its novel fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies.

Founded by the team that developed the world's first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck and Co.), Akston has partnered with Dechra Pharmaceuticals PLC to commercialize once-a-week canine and feline insulin therapies.

It operates a GMP biologics manufacturing facility and research laboratory at its Beverly, Mass. location.