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, 2021 – Akston 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 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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