Akston Biosciences Announces Positive Top-Line Data from Phase II Study of COVID-19 Vaccine in the Netherlands 

  • Two 45 μg doses and single 90 μg of protein subunit vaccine AKS-452 were generally well-tolerated and showed robust neutralizing antibody titers 
  • Primary immunogenicity endpoints were met 
  • Vaccine is shelf stable for at least 6 months at 25° C (77° F) 
  • Phase II/III trial starting in India 

Beverly, Mass. – December 22, 2021Akston Biosciences, Inc. a developer of new classes of biologic therapeutics, today announced positive data from the Phase II clinical trial of its second-generation SARS-CoV2 vaccine candidate, AKS-452.

The interim analysis showed a robust overall 98% seroconversion response after either two 45μg doses (100%), or a single 90μg dose (96%) in healthy adults at 56 days. 

It showed the vaccine induced a robust Th1/Th2 mixed immune response against the Receptor Binding Domain (RBD) of the coronavirus spike protein. 

The open-label study was conducted in the Netherlands and evaluated the safety, tolerability, reactogenicity and effectiveness of two 45 µg doses of AKS-452 with an adjuvant, given to 26 healthy participants ages 18 to 72, 28 days apart. In the trial’s second arm, a 26-participant cohort received a single 90 μg, which also contained an adjuvant.   

“The positive outcome of this trial is a significant step toward providing a low-cost, quickly manufactured protein subunit COVID vaccine that addresses the fundamental need for a safe, easily transported vaccine that can be stored for long periods without refrigeration and manufactured anywhere in the world where antibodies are made,” said Todd Zion, Ph.D., President and CEO of Akston Biosciences. “We look forward to sharing data from the Phase II/III trial that will start next month in India.” 

AKS-452 was well tolerated with a safety and tolerability profile consistent with the Phase I trial. Adverse Events were generally mild. The most commonly reported local symptom was injection site reaction (24.3%) while tiredness (6.3%) and headache (6.3%) were the most reported systemic symptoms.   

Akston is testing the ability of serum from subjects vaccinated with AKS-452 to neutralize the new omicron variant of the SARS-CoV-2 virus. The company has also initiated development of an omicron-specific version of its vaccine.   

About AKS-452
The AKS-452 is a protein sub-unit vaccine, a type of vaccine used safely for decades. AKS-452 does not contain mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus.

Based on Akston’s proprietary Fc fusion protein platform, AKS-452 is a SARS-CoV-2 protein subunit vaccine candidate 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 in vitro studies have demonstrated robust antibody neutralization of 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 at existing plants around the world.

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:
Edna Kaplan
Birnbach Communications for Akston Biosciences
617-974-8659
ekaplan@birnbachcom.com

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

  • 100 volunteers will participate in AKS-452 study; readouts expected Jan. 2022
  • Vaccine is shelf stable for at least six months at room temperature: 25° Celsius (77° Fahrenheit)
  • Double-blind placebo-controlled Phase II/III trial to start in Jan. 2022 with 1,500 volunteers

Beverly, Mass. – November 20, 2021 – Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today that the first of 100 subjects were dosed in an open-label bridging study of AKS-452, its protein subunit COVID-19 vaccine candidate, in India. AKS-452 is shelf stable for at least six months at room temperatures (up to 25° Celsius or 77° Fahrenheit) and maintains its potency for one month at 37° Celsius (99° Fahrenheit).

India’s Drug’s Controller General of India (DCGI), Ministry of Health and Family Welfare, approved the open-label bridging study, being conducted by the Supe Heart & Diabetes Hospital and Research Centre, in Nashik, India along with four other sites in the state of Maharashtra. Veeda Clinical Research Ltd., a CRO with experience overseeing complex clinical trials, is managing the study.

The open-label bridging study will be conducted with 100 healthy volunteers, age 18 and older. The first participants were dosed under the supervision of principal investigator, Pravin Dinkar Supe, M.D. founder of the Supe Heart & Diabetes Hospital and Research Centre. A double-blind Phase II/III study will follow with 1,500 healthy volunteers, age 18 and older, across 12 clinical sites in five states across India.

In both studies, healthy volunteers will receive two 90 µg doses 28 days apart. Of the 1,500 participants in the Phase II/III study, 1,150 will receive the two-dose regimen, while the remaining 350 will receive two placebo doses. The first dose will include AKS-452 and an adjuvant, which primes the body’s immune response, with the second dose consisting only of AKS-452. 

“The highly promising results from a previous Phase II trial in the Netherlands warrant moving forward with an open-label bridging study and the Phase II/III clinical trial here in India to help speed a low-cost, temperature-resistant vaccine that can be easily manufactured, transported and stored in economically deprived countries in Africa and Asia,” said Dr. Supe. “These countries lack the infrastructure to transport and store the currently-approved vaccines that require ultra-cold conditions.” 

“As a second-generation vaccine, AKS-452 has the potential to more easily safeguard the health of populations worldwide against COVID-19. Using our proprietary Fc fusion protein platform, AKS-452 is designed to be well tolerated for primary vaccination and boosting when immunity wanes,” said Todd Zion, Ph.D., President & CEO of Akston Biosciences.  

The first volunteer receives Akston Bioscience’s COVID-19 vaccine candidate, AKS-452, as part of a Phase II clinical trial in India. The vaccine is shelf-stable for at least six months at room temperatures up to 25°C (77°F).

About AKS-452
The AKS-452 is a protein sub-unit vaccine, a type of vaccine used safely and widely for decades. AKS-452 does not contain mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus.

Based on Akston’s proprietary Fc fusion protein platform, AKS-452 is a SARS-CoV-2 vaccine candidate 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 non-clinical testing has demonstrated robust antibody neutralization of SARS-CoV-2 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 Veeda Clinical Research Limited
Veeda Clinical Research Limited (“Veeda”) is one of the largest independent, full-service clinical research organizations, by revenue in India, headquartered in Ahmedabad, India. Veeda offers a range of bioequivalence studies and early and late phase clinical trials. Veeda has successfully completed several regulatory inspections and is approved by USFDA, UK MHRA, ANVISA (Brazil), and WHO. Veeda has experience in conducting complex clinical studies. www.veedacr.com.


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

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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