Akston Biosciences, dedicated to accelerating the next revolution in Animal Health, announced the publication in Nature Vaccines of phase II study results for AKS-452, based on Akston’s Ambifect® Fc-fusion protein platform. This Netherlands study showed the ability of a 90 ug subcutaneous dose to safely boost the immune response of individuals previously primed with a registered mRNA- or adenovirus-based SARS-CoV-2 vaccine. Fc-fusion protein vaccines derived from Akston’s platform provide a unique set of benefits, including inherent stability at ambient temperatures and low-cost, high-volume manufacture.

AKS-452 is a subunit vaccine consisting of an Fc fusion of the SARS-CoV-2 spike protein receptor binding domain (SP/RBD). While all phase II study subjects showed pre-existing SP/RBD binding and ACE2-inhibitory IgG titers, 60–68% responded to AKS-452 via ≥2-fold increase from days 28 to 90. Similar response kinetics against RBD mutant proteins (including omicrons) were observed but with slightly reduced titers relative to the wild type.

Earlier studies in Europe and India showed the utility of AKS-452 as a primary vaccine, and it has received approval for use in registration studies in India to test boosting and broadening immunity. Taken together, the clinical results have demonstrated that a vaccine built on the Ambifect® platform could be a safe, effective, and practical way to achieve large-scale primary and booster vaccination.

“Akston has also made significant strides in demonstrating the Ambifect® platform's potential beyond infectious disease vaccination,” said Todd Zion, Ph.D., President & CEO of Akston Biosciences. “We have also demonstrated that it can be applied to therapeutic vaccination, whereby the immune system is recruited to target proteins involved in non-communicable diseases such as dementia, chronic pain, and cancer.”

To further apply the Ambifect® platform, Akston recently spun out all human clinical vaccine applications with lead candidates targeting misfolded proteins involved in neurodegenerative diseases including Alzheimer’s and infectious diseases including Middle East Respiratory Syndrome (MERS) and Dengue fever. “Akston’s primary focus remains on animal health, where we are currently advancing lead therapeutic vaccines against nerve growth factor for chronic pain and IL-31 for atopic dermatitis," said Dr. Zion.

About Akston Biosciences

Akston Biosciences Corporation is dedicated to accelerating the next revolution in Animal Health by inventing, developing, and manufacturing breakthrough protein therapeutics for veterinary use. Its vertically integrated capabilities, including a kilogram-scale cGMP manufacturing facility dedicated to Animal Health, can significantly reduce the time and cost from discovery to commercial introduction. Akston leverages its Ambifect® Fc-fusion protein platform to create innovative, extended-duration biologics and therapeutic vaccines. Its facilities are located in Beverly, Mass. Additional information is available at akstonbio.com.

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