AKS-452

Akston Biosciences Receives Regulatory Approval for Phase II Clinical Trial for Shelf-Stable COVID-19 Vaccine Booster

Retrieved on: 
Thursday, March 31, 2022
Science, Biotechnology, Research, Pharmaceutical, Health, Infectious Diseases, Clinical Trials, Other Health, Risk, Merck & Co., Therapy, Janssen, Vaccination, DNA, Trial of the century, Volunteering, Martek Biosciences Corporation, Coronavirus, II, University Medical Center Groningen, Phase, Vaccine, EUA, Research, Serum, Hospital, Stride, Merck, CEO, Severe acute respiratory syndrome coronavirus 2, Immunity, Health, Developing country, AstraZeneca, Autoimmune disease, Immune system, SmartCell Technology, RNA transfection, Contract research organization, Time, COVID-19, CRO, Ageing, EMA, COVID-19 vaccine, RBD, GMP, Education, Seroconversion, Patient, Disease, Johnson & Johnson, Infection, Pharmaceutical industry, Pfizer, AKS-452, UNIVERSITY MEDICAL CENTER GRONINGEN, TRACER, AKSTON BIOSCIENCES

The trial is managed by TRACER Europe B.V., a CRO specializing in fast-track clinical trials and which oversaw the Phase I and II trials for AKS-452.

Key Points: 
  • The trial is managed by TRACER Europe B.V., a CRO specializing in fast-track clinical trials and which oversaw the Phase I and II trials for AKS-452.
  • Ph.D., the principal investigator at the UMCG for the AKS-452 Phase I and Phase II primary vaccine trials, will serve in the same capacity for the booster trial.
  • Given the apparent waning of immune response, a promising vaccine candidate like AKS-452 could be an effective booster.
  • A 1,600 subject Phase II/III clinical trial of AKS-452 as a two-dose primary vaccine is currently underway in India.

Akston Biosciences Announces Publication in Vaccine of Positive Data for a Room Temperature Protein Subunit COVID-19 Vaccine

Retrieved on: 
Tuesday, February 8, 2022
Research, Infectious Diseases, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, SARS, Merck & Co., Martek Biosciences Corporation, Research, Autoimmune disease, GMP, Â, Patient, Seroconversion, SmartCell Technology, Severe acute respiratory syndrome coronavirus 2, CEO, COVID, Therapy, Coronavirus, DPH, B.1.1.7, Merck, Infection, RBD, COVID-19, Vaccine, Pharmaceutical industry, Vaccine, AKS-452, Akston Biosciences, AKS-452, AKSTON BIOSCIENCES

Akston Biosciences Corporation , a developer of new classes of biologic therapeutics, announced publication of positive results from a 60-subject, open-label, Phase I trial of AKS-452, its shelf stable protein subunit COVID-19 vaccine candidate.

Key Points: 
  • Akston Biosciences Corporation , a developer of new classes of biologic therapeutics, announced publication of positive results from a 60-subject, open-label, Phase I trial of AKS-452, its shelf stable protein subunit COVID-19 vaccine candidate.
  • The trial met all primary and secondary endpoints, indicating minimal reactogenicity and optimized immunogenicity.
  • A recombinant subunit vaccine, AKS-452 comprises an Fc fusion protein of the SARS-CoV-2 viral spike protein receptor binding domain (RBD) antigen that is engineered to preserve effectiveness against viral variants.
  • 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.

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

Retrieved on: 
Saturday, November 20, 2021
Biotechnology, Pharmaceutical, Health, Clinical Trials, GMP, Patient, DCGI, RBD, Coronavirus, CEO, Merck, Ministry of Health and Family Welfare, Autoimmune disease, Martek Biosciences Corporation, Porantha Veeda Puguntha Veeda, WHO, Severe acute respiratory syndrome coronavirus 2, UK, Therapy, Ministry, Vaccine, USFDA, DPH, COVID-19, SmartCell Technology, ANVISA, Immunity, Research, CRO, Phase, Merck & Co., RNA transfection, Multimedia, Infection, Fahrenheit, Pharmaceutical industry, AKS-452, Akston Biosciences, Veeda Clinical Research Limited, AKS-452, AKSTON BIOSCIENCES, VEEDA CLINICAL RESEARCH LIMITED

View the full release here: https://www.businesswire.com/news/home/20211120005137/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20211120005137/en/
    The first volunteer receives Akston Bioscience's COVID-19 vaccine candidate, AKS-452, as part of a Phase II clinical trial in India.
  • Veeda Clinical Research Ltd., a CRO with experience overseeing complex clinical trials, is managing the study.
  • 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.
  • Veeda Clinical Research Limited (Veeda) is one of the largest independent, full-service clinical research organizations, by revenue in India, headquartered in Ahmedabad, India.

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

Retrieved on: 
Thursday, August 5, 2021
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Infectious Diseases, Clinical Trials, Alpha, Phase II, Volunteering, Research, Chief executive officer, Beta, Vaccine, DPH, COVID-19, University Medical Center Groningen, Seroconversion, Coronavirus, Disease, Temperature, SmartCell Technology, Martek Biosciences Corporation, Plant, Ageing, Infection, RBD, GMP, Contract research organization, Therapy, Health, Patient, Autoimmune disease, Merck, Merck & Co., RNA transfection, Hospital, Safety, CRO, Education, Pharmaceutical industry, the Phase II clinical trial, AKS-452, Akston Biosciences, TRACER, University Medical Center Groningen, THE PHASE II CLINICAL TRIAL, AKS-452, AKSTON BIOSCIENCES, TRACER, UNIVERSITY MEDICAL CENTER GRONINGEN

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.

Key Points: 
  • 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.
  • The trial is managed by TRACER Europe B.V., a Contract Research Organization (CRO) specializing in fast-track clinical trials.
  • 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.
  • 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.

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

Retrieved on: 
Thursday, July 8, 2021
Health, Infectious diseases, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Medical research, COVID-19 vaccine, Health sciences, Medicine, COVID-19 vaccines, Articles, Clinical trials, AKS-452, Akston Biosciences, TRACER, University Medical Center Groningen, AKS-452, AKSTON BIOSCIENCES, TRACER, UNIVERSITY MEDICAL CENTER GRONINGEN

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.

Key Points: 
  • 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 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.
  • The study gives us even more confidence that AKS-452 is a vaccine for everywhere and everyone in the world.

Akston Biosciences Launches Phase I/II Clinical Trial of Second-Generation COVID-19 Vaccine

Retrieved on: 
Monday, April 12, 2021
FDA, Health, Infectious diseases, Clinical trials, Pharmaceutical, Biotechnology, Medical research, Medicine, Health sciences, Medical specialties, Virology, COVID-19 vaccines, Clinical trials, COVID-19 vaccine, Vaccine, the Phase I/II clinical trial, AKS-452, Akston Biosciences, TRACER, University Medical Center Groningen

b"Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today that the first participants have been dosed in an open-label trial of AKS-452, its COVID-19 vaccine candidate.

Key Points: 
  • b"Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today that the first participants have been dosed in an open-label trial of AKS-452, its COVID-19 vaccine candidate.
  • View the full release here: https://www.businesswire.com/news/home/20210412005522/en/\nThe first volunteer receives Akston Bioscience's COVID-19 vaccine candidate, AKS-452, as part of a Phase I/II clinical trial.
  • The vaccine is shelf-stable for 4 months at temperatures up to 25\xc2\xb0C (77\xc2\xb0F).
  • TRACER and its partners provide its clients with the expertise, infrastructure, and capacity to rapidly generate accurate first-in-human clinical data.