Company Overview

Located in Beverly, Massachusetts, Akston Biosciences leverages its core expertise of designing novel fusion proteins to develop and manufacture new classes of biologic therapeutics for Type 1 diabetes (T1D) prevention, ultra-long acting insulin therapy, and vaccines.  Founded by the team that developed the world’s first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck & Co. in 2010), Akston has raised over $18 million in equity financing from the management team and private investors, as well as $10 million from National Institutes of Health grants and The Helmsley Charitable Trust.  Akston is partnered with Dechra Pharmaceuticals PLC (DPH) to commercialize AKS-321d, a once-a-week canine insulin therapy. 

Akston has built a diverse pipeline of therapeutic candidates for use in both human and animal health.  The human candidates cover a range of disease indications, while the animal candidates are already in clinical testing:

Akston Biosciences List of Therapeutic Candidates

Platform

Akston uses a proprietary Fc-fusion platform to develop its therapeutic candidates, which can take advantage of many different biological mechanisms-of-action.  This “Swiss-army” platform for multi-functional protein engineering supports tailored interaction with the immune system, delivery of customized agents for metabolic disease, and increased half-life.  The fully-biologic therapeutics derived from Akston’s platform can be manufactured at scale using established techniques. LEARN MORE

Type 1 Diabetes Prevention – AKS -107

Akston has developed AKS-107, a designer Fc-insulin fusion protein, to interrupt the key processes leading to insulin autoimmunity and Type 1 Diabetes. It utilizes a mutated insulin moiety which does not lower blood glucose and an Fc region to direct the immune system to delete targeted B cells. Akston has partnered with the Helmsley Charitable Trust, which is supporting AKS-107 GMP manufacturing and Sanford Research, Inc., a South Dakota not-for-profit corporation, which will conduct the Phase 1 clinical trial. It has also received significant support from the National Institutes of Health (NIH) to support IND-enabling safety pharmacology and toxicology studies. LEARN MORE

COVID-19 Vaccine – AKS-452

AKS-452 is a novel, biologically engineered SARS-CoV-2-RBD-Fc fusion protein designed to induce and/or augment antibody titers in patients against the receptor binding domain (RBD) of the novel SARS-CoV-2 coronavirus that causes COVID-19.  Preclinical animal studies have shown robust, neutralizing antibody production at microgram doses.  Akston believes that AKS-452 is the most advanced RBD-Fc fusion protein in commercial development and that the nature of the construct can provide unique advantages compared to the nucleic acid, viral-vectored, and inactivated virus vaccine candidates currently being tested. LEARN MORE

Veterinary Insulin Therapies – AKS-321d and AKS-425c

Akston is partnered with Dechra Pharmaceuticals PLC to commercialize AKS-321d, a one-a-week insulin therapy for dogs that is a drop-in replacement to the current twice-a-day insulin treatment. It utilizes a specially-designed insulin to increase glucose-lowering bioactivity and a modified dog Fc, which enables a long half-life through FcRn recycling, with no immune system activation. Multiple field studies have demonstrated successful multi-month treatment of dozens of client-owned diabetic dogs. AKS-425c, the variant for cats, which is designed to provide substantially the same performance, is currently in field testing in client-owned diabetic cats. LEARN MORE

Human Insulin Therapies – AKS-433 and AKS-444

Using the knowledge gained from its development of long-acting veterinary insulins, Akston has developed two novel human insulin candidates. AKS-433 is a once-a-week injectable therapy that uses a modified human Fc region paired with a designer insulin. AKS-444 incorporates proprietary saccharides to provide true once-a-day glucose-responsive performance. Both candidates are currently in pre-clinical development.