- 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, MA, USA I July 8, 2021 I 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.
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- 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, MA, USA I July 8, 2021 I 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.
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