Tag - Akston Biosciences

Akston Biosciences Ends Vaccine Partnership with Stelis, Continues to Advance COVID Universal Booster EUA

Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today it has ended its AKS-452 licensing, manufacturing, and commercialization agreement with Stelis Biopharma Limited, an arm of Strides Pharma Science Ltd. Akston has reclaimed all rights to AKS-452, a room temperature stable, low-cost, protein subunit COVID-19 vaccine. AKS-452 has completed a Phase II/III clinical trial in India, with data showing robust safety profile and a 91% seroconversion rate at Day 56. Akston is now working with a...
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Akston Biosciences Strengthens Board with Addition of John T. Preston

Akston Biosciences Corporation, a clinical-stage biotechnology company, today announced that John T. Preston, a founder of TEM Capital, has joined its Board of Directors. A recipient of numerous awards and previous advisor to several government agencies and expert witness for Congress, Preston brings to Akston his decades of experience in technology commercialization and intellectual property licensing. Preston spent most of his career at the Massachusetts Institute of Technology (MIT), managing the interface between researchers and industry. His titles included Associate...
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Akston Biosciences Announces Positive Interim Phase II Results from COVID “Universal” Booster Vaccine Trial

Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, today announced top-line clinical results for its Phase II COVID-19 “universal” booster vaccine, AKS-452. An interim analysis of the data found that 93% of subjects previously vaccinated with Pfizer, Moderna, Johnson & Johnson (Janssen), and AstraZeneca vaccines showed an increase in neutralizing antibody titers after receiving a single dose of AKS-452. The average neutralization titers across all subjects increased 4-fold against the Wuhan strain and 5-fold against the Omicron...
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Akston starts small and likes it that way

Akston 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. Read more >>
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Strides Pharma jumps on positive outcome of COVID-19 vaccine trials

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

Akston 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...
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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 Medical...
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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 more...
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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 healthy...
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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 B.V.,...
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