Akston Biosciences

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

Ziad2022-11-25T13:59:57-05:00Akston 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 B.V.,...

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

Ziad2022-11-25T13:59:58-05:00Akston 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 capabilities...

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

Ziad2022-11-25T13:59:58-05:00Akston 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 degrees...

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

Ziad2022-11-25T13:59:58-05:00A 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 one...

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

Ziad2022-11-25T13:59:58-05:00Akston 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, which...

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

Ziad2022-11-25T14:00:10-05:00The 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. Read more >>

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

Ziad2022-11-25T14:00:11-05:00Akston 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. Read more >>

Akston Begins Trials For Room Temperature Covid Shot As Next-Generation Vaccine Race Heats Up

Ziad2022-11-25T14:00:11-05:00Massachusetts-based Akston Biosciences launched mid-to-late stage clinical trials for its Covid-19 vaccine Saturday. Read more >>

India to Start Clinical Trials of US-Based Second Generation, Low-Cost Covid-19 Vaccine

Ziad2022-11-25T14:00:11-05:00India will soon start clinical trials of US-based Akston Biosciences second-generation Covid-19 vaccine — one of the most promising candidates that can be rapidly produced at a low cost, suitable for repeated dosing if immunity wanes and requires no refrigeration. The vaccine samples have been sent to the Central Drugs Laboratory in Kasauli as a protocol for checking the safety prior to starting its use in clinical trials. Read more >>

The Next COVID Challenge: Building an Arsenal of Vaccines

Ziad2022-11-25T14:00:12-05:00For months, international partners have pressured the United States about intellectual property (IP) concerns and access to SARS-CoV-2 vaccines. As the country emerges from the worst of the pandemic, President Joe Biden now has an opportunity to shift his administration’s focus to realizing its longstanding promise of making the United States “the arsenal of vaccines for the world” (1). However, the country cannot accomplish that goal just by exporting mRNA vaccines and waiving IP protections. The current generation of vaccines...