Tag - Akston Biosciences

Akston Biosciences Doses First Participants in Phase II Clinical Trial for Shelf-Stable COVID-19 Booster

Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today it dosed the first set of volunteers in an open-label study of AKS-452, its protein subunit COVID-19 vaccine, as a booster. The Phase II booster study is designed to investigate the response of the immune system in up to 600 volunteers who have previously been vaccinated with EMA-registered vaccines from Pfizer, Moderna, Johnson & Johnson (Janssen) and AstraZeneca. The study is being conducted at the University […]

Akston Biosciences CEO to Present at the World Vaccine Congress

Akston Biosciences Corporation, a developer of new classes of biologics, announced that its president and CEO, Todd Zion, Ph.D., has been invited to present at this year’s World Vaccine Congress (WVC). This is the largest, most prestigious meeting dedicated to vaccines and will be held on April 18-21 in Washington, DC. In addition, the company’s Fc-fusion protein platform has been shortlisted in the best new vaccine technology category of the World Vaccine Congress Vaccine Industry Excellence (ViE) Awards. Read […]

Akston Biosciences Doses First Volunteers in Phase II/III Clinical Trial of Low Cost, Shelf Stable COVID-19 Vaccine

Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today that the first volunteers in a Phase II/III clinical study of AKS-452, its low cost, shelf stable protein subunit COVID-19 vaccine, were dosed in India. India’s Central Drugs Standard Control Organization (CDSCO) approved the double-blind, placebo-controlled trial, initiated by Ahmedabad-based Veeda Clinical Research Limited, whose data will be submitted in an application for Emergency Use Authorization (EUA). The multicenter trial will complete the enrollment of 1,500 […]

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

Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today it received regulatory approval in the Netherlands to conduct an open-label study of AKS-452, its protein subunit COVID-19 vaccine, as a booster. The study is designed to investigate the response of the immune system to an AKS-452 booster shot in 600 volunteers who have previously been vaccinated with EMA-registered vaccines from Pfizer, Moderna, Johnson & Johnson (Janssen) and AstraZeneca. The trial is managed by TRACER Europe […]

Akston Biosciences and Biolexis Collaborate to Launch a Room Temperature Stable 2nd Generation COVID-19 Vaccine in 130+ Countries

Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, and Biolexis, a division of Stelis Biopharma Limited (Stelis), announced today that they have entered into a licensing, manufacturing and commercialization agreement for Akston’s AKS-452, a protein subunit COVID-19 vaccine. Under the agreement, Biolexis gains the right to manufacture and commercialize AKS-452 (branded as AmbiVax-CTM) in India and over 130 countries in Asia, Latin America, and Africa largely covering the low-and-middle-income countries (LMICs). Biolexis will also leverage the […]

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

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 adjuvanted vaccine was generally well-tolerated and produced a 100% seroconversion rate in the 90 µg single-dose regimen, as well as in the 45 µg and 90 µg two-dose regimens — Protein subunit vaccine, shelf stable for at least 6 months at 25 degrees C (77 […]

Easier-To-Produce Room Temperature Covid Shot Shows Promise In Early Clinical Trials

A protein-based Covid-19 vaccine by Akston Biosciences that can be stored at room temperature and efficiently manufactured using existing technology was well-tolerated and provoked an immune response in all those receiving higher doses, according to data from an early-stage clinical trial, as the company vies to expand vaccine access around the world. The early-stage clinical trial, published in the medical journal Vaccine, tested the shot in 60 healthy adults ages 18 to 65 years in the Netherlands, who received […]

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

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 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, […]

What will tomorrow’s Covid-19 vaccines be like?

The first generation of Covid-19 vaccines was developed in record time. But now scientists have grander plans – for more potent immunity, easier transport, and mutation-proofing…
While Zion, an entrepreneur and chief executive of a small start-up called Akston Biosciences, was personally relieved that the tide was turning against the global pandemic, he faced the unenviable task of trying to convince his employees that their hard graft had not been in vain.
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