Akston Biosciences Strengthens Board with Addition of John T. Preston

BEVERLY, Mass. – Jan. 23, 2023 – Akston Biosciences Corporation, a clinical-stage biotechnology company, today announced that John T. Preston, a founder of TEM Capital, has joined its Board of Directors. A recipient of numerous awards and previous advisor to several government agencies and expert witness for Congress, Preston brings to Akston his decades of experience in technology commercialization and intellectual property licensing.

Preston spent most of his career at the Massachusetts Institute of Technology (MIT), managing the interface between researchers and industry. His titles included Associate Director of the MIT Industrial Program, Director of Technology Licensing and Director of Technology Development. In those capacities, he supervised activities that led to the creation of hundreds of new technology-based companies as well as the negotiation of thousands of licenses with existing companies.

He was awarded the rank of “Knight of the Order of National Merit of France” by French President Mitterrand and the “Hammer Award for Reinventing Government” by Vice President Gore. He chaired George H.W. Bush’s conference announcing the President’s technology initiative. Preston has assisted many startups including Rivian Automotive, Puretech Ventures, Unity Aluminum, Vantem Global, Eco Material Technologies / Green Cement Inc., and ExThera Medical. He also has served as a director of four public companies, including Clean Harbors, and as a Board Advisor to Mars Incorporated.

“I am very interested in helping entrepreneurs with transformative innovations that make a difference for society and represent a significant leap over prior commercial practices,” said Preston. “I look forward to helping Akston and its partners get real products into the hands of those who need them most across the globe.”

“Akston is at an inflection point, as we monetize the candidates we have engineered for cost-effective, high impact biologic pharmaceuticals,” stated Todd Zion, Ph.D., President & CEO of Akston Biosciences. “John has a pragmatic approach to value creation and we expect that his wealth of experience in licensing and partnerships will be especially valuable to us in the coming years.”


About Akston Biosciences
Akston Biosciences Corporation leverages its Ambifect™ Fc-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 & Co.), Akston owns and operates a cGMP biologics cleanroom facility that manufactures kilogram-scale batches of drug substance. This, along with its research and process development laboratories, are located at its Beverly, Mass. location. Additional information is available at www.akstonbio.com.


Contact:
Linda Pendergast-Savage
Birnbach Communications for Akston Biosciences
1-508-224-7905
lpendergastsavage@birnbachcom.com

Akston Biosciences Completes Second Licensing and Supply Agreement with Dechra Pharmaceuticals PLC

Akston Biosciences Signs Licensing Agreement with Dechra Pharma for AKS-425c, a Once-a-Week Insulin Therapy for Cats

Follows earlier agreement between Akston and Dechra for AKS-321d, a once-a-week insulin therapy for dogs

BEVERLY, Mass., & LONDON, UK– Feb. 9, 2021 – Akston Biosciences, which develops new classes of biologic therapeutics, today announced it has signed licensing, development and supply agreements with Dechra Pharmaceuticals PLC, a global veterinary pharmaceuticals company, for the commercialization of AKS-425c, a once-a-week insulin therapy for the treatment of diabetes in cats.

The companies expect development to be completed within five years and receive marketing authorizations in the U.S., European Union and other global markets. The supply agreement calls for Akston to be the exclusive manufacturer of the product to be marketed by Dechra. The multi-million-dollar licensing and development agreement includes payments to Akston on signing, for development milestones, and a royalty on sales.
In 2019, the two companies signed a licensing and supply agreement for AKS-321d, a once-a-week insulin therapy for dogs. Dechra has successfully completed a proof-of-concept (POC) study of it in privately-owned veterinary practices with client-owned diabetic dogs.

“The current twice-a-day treatment for dogs and cats with diabetes is difficult on pets and most owners prefer the convenience of a once-a-week injection that can improve the quality of life for their pets,” said Todd Zion, Ph.D., President & CEO of Akston Biosciences. “Dechra has proven to be a strong and valued partner in the commercialization of our ultra-long-acting insulin technology for pets.”

Ian Page, CEO of Dechra Pharmaceuticals, added, “Our work with Akston’s long-acting insulin for dogs, and now for cats, continues to position Dechra as a world leader in veterinary endocrinology. Once approved, these two biologic drugs will be amongst the most significant products in our portfolio as we continue to expand our range of novel therapeutics.”

More than 150,000 cats are diagnosed with diabetes each year in the U.S. and the E.U. Current therapy is indicated for twice-a-day subcutaneous injection and owners generally find the treatment regimen to be onerous and error-prone. A significant number of animals are euthanized within one year of diagnosis. AKS-425c for cats offers the potential of a once-a-week treatment, using specially-designed insulin to increase glucose-lowering bioactivity and a modified cat Fc, which enables a long half-life through FcRn recycling. Currently, AKS-425c is in field testing in veterinary centers with client-owned, diabetic cats.


About Akston Biosciences Akston Biosciences leverages its novel fusion protein platform to develop and manufacture new classes of biologics, including autoimmune disease therapies, ultra-long-acting insulins, 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), It operates a 1,000-liter GMP biologics manufacturing facility and research laboratory at its Beverly, MA location. akstonbio.com.

About Dechra Dechra is a global veterinary pharmaceuticals and related products business. Its expertise is in the development, manufacture, marketing and sales of high-quality products exclusively for veterinarians worldwide. The majority of Dechra’s products are focused on key therapeutic categories where the company has leading market positions, and many of its products are used to treat medical conditions for which there is no other effective solution or have a clinical or dosing advantage over competitive products.

For more information please visit: www.dechra.com or email corporate.enquiries@dechra.com.

Stock Code: Full Listing (Pharmaceuticals): DPH.

Trademarks: Dechra and the Dechra “D” logo are registered trademarks of Dechra Pharmaceuticals PLC.


Contact:
Linda Pendergast-Savage
Birnbach Communications for Akston Biosciences
1-508-224-7905
lpendergastsavage@birnbachcom.com

Akston Biosciences Signs Licensing Agreement with Dechra Pharma
for AKS-425c, a Once-a-Week Insulin Therapy for Cats

Background: For the treatment of diabetes mellitus (DM) in dogs, novel insulins with decreased injection frequency while maintaining safety and efficacy are desirable. Insulin fused with immunoglobulin-fragment-crystallizable (Fc) has an ultra-long plasma half-life because it recycles through cells, protected from proteolysis.

READ THE ARTICLE

Helmsley Charitable Trust and Akston Biosciences Corporation Extend Partnership

July 24, 2019 – The Leona M. and Harry B. Helmsley Charitable Trust has completed an extension of its program-related investment (PRI) with Akston Biosciences to support the process development and GMP manufacturing of AKS-107, the company’s lead diabetes candidate for the prevention of Type 1 Diabetes. As part of the agreement, Helmsley will provide an additional $3.1 million over a two-year period in the form of a loan to advance AKS-107 into a first-in-man clinical trial in 2020. Dr. Todd Zion, Akston’s CEO said, “the Helmsley Charitable Trust has been a critical and early supporter of our Type 1 Diabetes therapeutic program, and we are delighted to see their continued support of our program as we advance our lead candidate into the clinic.”

Akston Biosciences Announces Positive Interim Phase II Results from COVID “Universal” Booster Vaccine Trial

 

Study investigated boosting those previously vaccinated with EMA-registered vaccines 

  • 93% of those previously vaccinated had higher neutralizing antibody titers after a single dose of AKS-452
  • Sera collected from participants 28 days after administration of a 90 µg booster dose of the COVID-19 vaccine showed a substantial increase in neutralizing antibody response
  • No Adverse Effects and no Serious Adverse Effects attributable to AKS-452 occurred during the study

 

BEVERLY, Mass. – Nov. 1, 2022 – Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, today announced top-line clinical results for its Phase II COVID-19 “universal” booster vaccine, AKS-452. An interim analysis of the data found that 93% of subjects previously vaccinated with Pfizer, Moderna, Johnson & Johnson (Janssen), and AstraZeneca vaccines showed an increase in neutralizing antibody titers after receiving a single dose of AKS-452. The average neutralization titers across all subjects increased 4-fold against the Wuhan strain and 5-fold against the Omicron variants at Day 28. There were no safety issues reported..

The non-randomized, open-label, safety, and efficacy study was conducted and managed by TRACER Europe B.V., a CRO specializing in fast-track clinical trials that previously conducted Phase I and II trials for AKS-452 in the Netherlands. Seventy healthy participants between the ages of 18 and 85 received one 90 µg dose of the AKS-452 antigen. The vaccine was well tolerated with data indicating a favorable safety profile, similar to that of the registered vaccines. Antibody levels, virus neutralization activity, and T cell response will be measured at intervals over the next nine months.

“The favorable safety and immunogenicity profiles at the interim analysis of this study, particularly against variants, support a Phase III universal booster study for AKS-452,” said Todd Zion, Ph.D., President & CEO of Akston Biosciences. “Immunity from infection or vaccination quickly wanes and new waves of elusive strains are presenting continuing challenges. Boosting immunity in vulnerable populations will be needed for years to come and vaccines must be low cost and easy to distribute.”

A 1,600 subject Phase II/III clinical trial of AKS-452 as a two-dose primary vaccine was completed earlier this year in India. The positive results from that study have been submitted as part of an Emergency Use Application in India.

AKS-452 is a second-generation vaccine based on Akston’s novel Fc-fusion platform. Its composition provides direct presentation to the immune system and robust protection against virus variants. Using proven antibody technologies, it inherently supports high production yields and stability at high temperatures.

 

 

About Tracer TRACER Europe B.V. (“TRACER”) is a Clinical Research Organization (CRO) specializing in fast-track solutions for testing innovative biologic medicines and is a founding member of the COVID-19 Rapid Cure Task Force (RCTF). TRACER and its partners provide its clients with the expertise, infrastructure, and capacity to rapidly generate accurate first-in-human clinical data. www.tracercro.com.

About Akston Biosciences AAkston Biosciences Corporation leverages its novel Fc-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 & Co.), Akston owns and operates a GMP biologics cleanroom facility that manufactures kilogram-scale batches of drug substance. This, along with its research and process development laboratories, are located at its Beverly, Mass. location. Additional information is available at akstonbio.com.


Akston Biosciences Receives U.S. Patent for Once-A-Week Human Insulin

BEVERLY, Mass. – August 9, 2022 – Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, today announced that it has recently been granted U.S. patent 11,352,407. The patent covers recombinantly manufactured ultra-long acting insulin Fc-fusion proteins for use as once-a-week insulin treatments for diabetes. These insulin Fc-fusion proteins comprise an insulin polypeptide connected via a peptide linker to an Fc-fragment of human origin.

This is the first patent granted to Akston covering once-a-week insulin Fc-fusion proteins for treating human diabetes and the lead compound covered by it, AKS-440, is in manufacturing development at Akston’s Beverly, Massachusetts facility. AKS-440 was designed using Akston’s proprietary Fc-fusion protein platform, which has been used to rapidly and efficiently generate candidate compounds for a diverse set of disease indications.

The company has previously been granted patents in both the U.S, and Europe covering once-a-week insulins for treating canine and feline diabetes. Akston has 17 issued patents world-wide covering not only these insulin therapy candidates but also a candidate in development designed to delay or prevent autoimmune diabetes, and a novel COVID-19 vaccine.  The veterinary insulins have been licensed to Dechra Pharmaceuticals PLC and the vaccine has been licensed to Biolexis, a division of the Strides Group, which plans to launch it as AmbiVax-C™ in global markets.

“This new patent demonstrates the value of Akston’s proprietary Fc-fusion protein platform,” said Todd Zion, Ph.D., President & CEO of Akston Biosciences. “We utilize the platform to tailor the different components of an Fc-fusion protein to optimize safety, efficacy, and manufacturability. Once a group of promising candidates is found, variants can be designed, synthesized, and tested to improve overall performance through a rapid and iterative process. This can significantly reduce the time and cost of developing vaccines and therapies.”


About Akston Biosciences Akston Biosciences Corporation leverages its novel Fc-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 & Co.), Akston owns and operates a GMP biologics cleanroom facility that manufactures kilogram-scale batches of drug substance. This, along with its research and process development laboratories, are located at its Beverly, Mass. location. Additional information is available at akstonbio.com.