Tag - Akston Biosciences

Akston starts small and likes it that way

Ziad2022-11-25T13:59:44-05:00Akston Biosciences Corp. emerged from a successful small company that was sold to a pharma major. For Todd Zion, that’s a back-to-basics move that suits him just fine. Zion co-founded Smartcells Inc. in 2003 with technology developed at the Massachusetts Institute of Technology. The company went on to develop the once-daily injectable self-regulating insulin product, Smartinsulin, and sold it to Merck & Co. in what was at the time one of the largest preclinical pharmaceutical acquisitions ever.

Strides Pharma jumps on positive outcome of COVID-19 vaccine trials

Ziad2022-11-25T13:59:45-05:00Strides Pharma Science rallied 7.70% to Rs 336.50 after the company's subsidiary Biolexis and Akston Biosciences announce encouraging top-line results from phase II/III trial of their thermostable 2nd gen COVID-19 vaccine. The vaccine was well tolerated, with no reported safety issues and is shelf-stable for over six months at room temperature at 25 celsius and potency for one month at 37 celsius. The interim analysis showed 91% seroconversion rate at day 56. The vaccine will be produced at Stelis Biopharma,...

Biolexis and Akston Biosciences Announce Encouraging Top-Line Results from Phase II/III Trial of their Thermostable 2nd Gen COVID-19 Vaccine

Ziad2022-11-25T13:59:45-05:00Akston Biosciences Corporation and Biolexis, a Strides Group Company, today announced results from a Phase II/III clinical trial in India of the SARS-CoV-2 vaccine, AKS-452, in which 1,600 healthy volunteers participated – 100 in an open-label bridging study and 1,500 in Phase II/III, double-blind, placebo-controlled trial. An interim analysis of this data shows no significant safety issues and a 91% seroconversion rate at Day 56. Volunteers in the bridging study had antibody titers that persisted at statistically-significant high levels through...

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

Ziad2022-11-25T13:59:57-05:00Akston 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 Medical...

Akston Biosciences CEO to Present at the World Vaccine Congress

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

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

Ziad2022-11-25T13:59:57-05:00Akston 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 healthy...

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...