Akston Biosciences Doses First Subjects in Phase II Clinical Trial of Second-Generation Protein Subunit COVID-19 Vaccine

  • First Phase II subjects dosed with AKS-452, COVID-19 vaccine candidate in Dutch trial
  • New data shows vaccine is shelf stable for at least six months at 25 degrees Celsius (77° Fahrenheit)
  • Readouts expected in Q3 of 2021

Beverly, Mass. – August 5, 2021 – Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today that the first participants have been dosed in a Phase II open-label trial of AKS-452, its protein subunit COVID-19 vaccine candidate.

Fifty-two volunteers will receive either one- or two-dose regimens as part of the Phase II trial conducted at University Medical Center Groningen (UMCG), one of the largest hospitals in the Netherlands. The trial is managed by TRACER Europe B.V., a Contract Research Organization (CRO) specializing in fast-track clinical trials.

The Phase I trial showed AKS-452 to be safe and well-tolerated. Most importantly, AKS-452 produced a 100% seroconversion rate in the 90 microgram single-dose regimen, as well as in the 45 microgram two-dose regimen. 

“From Phase I, we know the AKS-452 showed limited side-effects, comparable to the current registered anti-COVID-19 vaccines,” said Schelto Kruijff, M.D. Ph.D., the trial’s principal investigator at the UMCG. “The new data that this vaccine candidate is shelf stable at room temperature for at least six months makes it ideal for countries such as Malawi and Kenya, where I volunteer, because it can be transported and stored for months without refrigeration.” 

The AKS-452 has been shown to be shelf stable for at least six months at 25° Celsius (77° Fahrenheit) and maintains its potency for one month at 37° Celsius (99° Fahrenheit). 

“The extended shelf stability, the clinical data that show a single injection of the 90 microgram dose provides 100% seroconversion at significantly higher titers than confirmed COVID-19-positive convalescent serum samples, and the ease of manufacturing relative to current approved vaccines, indicate that our 2nd generation vaccine has the potential to more easily safeguard the health of populations worldwide against COVID,” said Todd Zion, Ph.D., President & CEO of Akston Biosciences.   

Potential volunteers can still sign up to participate in the study and receive the AKS-452, a protein sub-unit vaccine, a type of vaccine used safely for decades, and does not include mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus. All will receive the vaccine and none will receive a placebo.  To learn more, click here: https://www.umcg.nl/-/medisch-wetenschappelijk-onderzoek/act-studie.

Gerard Metselaar said he felt lucky to get to participate in Phase I: “I am living proof that this vaccine is effective,” he said. Because of the study, “I was vaccinated way before anyone in my age group. Even though that was a great feeling, I gained most satisfaction from knowing this will help so many other people get closer to their vaccination.”

About the Phase II clinical trial
The Phase I/II clinical trial, an open-label study, evaluates a total of 112 healthy volunteers between the ages of 18 and 85 to determine safety, tolerability, and immune response, participants in Phase II will receive either one dose of 90 micrograms or two doses of 45 micrograms 28 days apart.

About AKS-452
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 (RBD) 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 billion doses per year.

About Akston Biosciences
Akston Biosciences Corporation 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 & Co.), Akston has partnered with Dechra Pharmaceuticals PLC (DPH) 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. www.akstonbio.com 

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 University Medical Center Groningen
The University Medical Center Groningen (UMCG) is one of the largest hospitals in the Netherlands. The more than 12,000 employees work together on care, research, training and education with the common goal: building the future of health. Through innovative and sound research UMCG aims to understand mechanisms of disease; to push borders for diagnostics and treatment; and to help build a network for sustainable health. All of its research focuses on Healthy Ageing. Talent development and state-of-the-art infrastructure are of paramount importance to UMCG. 


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

Akston Biosciences Announces Commercial Supply Agreement of Seppic’s Adjuvant to Formulate Akston Shelf-stable COVID-19 Vaccine at Global Scale

New data shows protein-based AKS-452 vaccine is shelf-stable for six months at 25° C (77° F)

Beverly, Mass., USA & Paris, France – July 21, 2021 – Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, today announced a commercial agreement with Seppic S.A., a supplier of specialty healthcare ingredients, for the supply of adjuvant for use in Akston’s COVID-19 Fc fusion protein vaccine candidate, AKS-452.

Seppic will provide MontanideTM ISA 720 VG adjuvant for use in the vaccine, and is working with Akston to produce 10 million doses of adjuvant by late 2021 and up to 100 million 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 (UMCG), 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).

“We are excited to work together to combine the great potential of Akston’s AKS-452 with Seppic’s deep experience in vaccine adjuvants. Seppic is proud to support Akston’s temperature-stable COVID-19 vaccine with the supply of its adjuvant and hopes it will be globally available,” said Jean-Baptiste Dellon, CEO of Seppic S.A.

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

“We are confident about the potential for AKS-452 to transform the global COVID-19 landscape for those most at risk,” said Todd Zion, Ph.D., President & CEO of Akston Biosciences. “There is a clear unmet need for AKS-452, and now, with our close collaboration with Seppic, we have the combined resources, expertise, and determination to meet this need and deliver an effective, affordable, and easily transportable vaccine to the global population.” 

About AKS-452
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 (RBD) 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 billion doses per year.

About Seppic S.A.
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. www.seppic.com

About Akston Biosciences
Akston Biosciences Corporation 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 & Co.), Akston has partnered with Dechra Pharmaceuticals PLC (DPH) 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. www.akstonbio.com 


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

Akston Biosciences Announces Positive Phase I Data for Second-Generation COVID-19 Vaccine Candidate

  • 100% seroconversion rate with single 90 microgram dose
  • Well-tolerated, with mild AEs, comparable to current registered vaccines
  • Protein subunit vaccine, shelf stable for 4 months at 25 degrees Celsius (77° Fahrenheit)
  • Phase II trial planned to start in July 2021, read-outs expected in Q3 2021

BEVERLY, Mass. – July 08, 2021 – Today, Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced positive results from a 60-subject, open-label, Phase I trial of AKS-452, its protein subunit, room temperature stable, COVID-19 vaccine candidate. The vaccine was generally well-tolerated, and produced a 100% conversion rate in the 90 microgram single-dose regimen, as well as the 45 and 90 microgram two-dose regimens. 

A Phase II trial, with both one- and two-dose regimens, is planned to start later this month at the University Medical Center Groningen (UMCG), one of the largest hospitals in the Netherlands. The trial will be managed by TRACER Europe B.V., a Contract Research Organization (CRO) specializing in fast-track clinical trials. 

“The results are very encouraging, showing limited side-effects, comparable to current registered anti-COVID-19 vaccines, over all dosing-cohorts,” said Schelto Kruijff, M.D. Ph.D., the trial’s principal investigator at the UMCG. “It showed a dose-dependent increase in Anti-Spike Protein Receptor Binding Domain titers with remarkably high seroconversion rates.”

“The study confirms the preclinical data that showed AKS-452 is safe, and a single injection of the 90 microgram dose provides 100% seroconversion, with significantly higher titers than confirmed COVID-19-positive convalescent serum samples,” stated Todd Zion, Ph.D., President & CEO of Akston Biosciences. “This is an important milestone for our program indicating that it can deliver key benefits to countries that need an affordable and easily transportable vaccine. The study gives us even more confidence that AKS-452 is a vaccine for everywhere and everyone in the world.” 

About AKS-452
Based on Akston’s proprietary Fc fusion protein platform, AKS-452 is a SARS CoV-2 protein subunit vaccine designed to induce a Th1/Th2 mixed immune response in patients against the Receptor Binding Domain (RBD) of the novel coronavirus spike protein. As 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 (Alpha) and B.1.351 (Gamma) 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 billion doses per year.

About Akston Biosciences
Akston Biosciences Corporation 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 & Co.), Akston has partnered with Dechra Pharmaceuticals PLC (DPH) 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. www.akstonbio.com

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 University Medical Center Groningen
The University Medical Center Groningen (UMCG) is one of the largest hospitals in the Netherlands. Its more than 12,000 employees work together on care, research, training and education with the common goal: building the future of health. Through innovative and sound research UMCG aims to understand mechanisms of disease; to push borders for diagnostics and treatment; and to help build a network for sustainable health. All of its research focuses on Healthy Aging. Talent development and state-of-the-art infrastructure are of paramount importance to UMCG. 


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

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