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    [{"orgOrder":0,"company":"Akston Biosciences","sponsor":"University Medical Center Groningen","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Akston Biosciences Doses First Patient with Next-Gen Covid-19 Vaccine","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Vaccine","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Akston Biosciences","sponsor":"Seppic","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Akston Biosciences Announces Commercial Supply Agreement of Seppic\u2019s Adjuvant to Formulate Akston COVID-19 Vaccine","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I\/ Phase 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              Akston Biosciences

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

              Details:

              Akston has reclaimed all rights to AKS-452, a room temperature stable, low-cost, protein subunit COVID-19 vaccine. Akston is continuing its progress to secure Emergency Use Authorization (EUA) in India and has begun working with a new CDMO to produce AKS-452.

              Lead Product(s): AKS-452

              Therapeutic Area: Infections and Infectious Diseases Product Name: AKS-452

              Highest Development Status: Phase II Product Type: Vaccine

              Partner/Sponsor/Collaborator: Stelis Biopharma

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Termination March 07, 2023

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              Akston Biosciences

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              Akston Biosciences Announces Positive Interim Phase II Results from COVID “Universal” Booster Vaccine Trial

              Details:

              AKS-452 is a second-generation vaccine based on Akston’s novel Fc-fusion platform. Its composition provides direct presentation to the immune system and robust protection against virus variants.

              Lead Product(s): AKS-452

              Therapeutic Area: Infections and Infectious Diseases Product Name: AKS-452

              Highest Development Status: Phase II Product Type: Vaccine

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 01, 2022

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              Akston Biosciences

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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

              Details:

              Results of 100 subjects bridging study and 1,500 subjects placebo-controlled trial of Akston’s AKS-452 announced. Interim analysis shows a 91% seroconversion rate.

              Lead Product(s): AKS-452

              Therapeutic Area: Infections and Infectious Diseases Product Name: AKS-452

              Highest Development Status: Phase II/ Phase III Product Type: Vaccine

              Partner/Sponsor/Collaborator: Biolexis

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 24, 2022

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              Akston Biosciences

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

              Details:

              Up to 600 volunteers will participate in an AKS-452 COVID booster study in the Netherlands to investigate boosting the immune response of those previously vaccinated with EMA-registered vaccines.

              Lead Product(s): AKS-452

              Therapeutic Area: Infections and Infectious Diseases Product Name: AKS-452

              Highest Development Status: Phase II Product Type: Vaccine

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 12, 2022

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

              Details:

              AKS-452 or AmbiVax-CTM is a first-of-its-kind thermostable COVID-19 vaccine developed for all parts of the world. AmbiVax-CTM is a SARS-CoV-2 protein subunit vaccine designed to induce a Th1/Th2 mixed immune response in patients against the Receptor Binding Domain.

              Lead Product(s): AKS-452

              Therapeutic Area: Infections and Infectious Diseases Product Name: AmbiVax-C

              Highest Development Status: Phase II/ Phase III Product Type: Vaccine

              Partner/Sponsor/Collaborator: University Medical Centre Groningen

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 07, 2022

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              Akston Biosciences

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

              Details:

              AKS-452 is a protein sub-unit vaccine, a type of vaccine used safely and widely for decades. AKS-452 does not contain mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus.

              Lead Product(s): AKS-452

              Therapeutic Area: Infections and Infectious Diseases Product Name: AKS-452

              Highest Development Status: Phase II Product Type: Vaccine

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 31, 2022

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

              Details:

              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).

              Lead Product(s): AKS-452

              Therapeutic Area: Infections and Infectious Diseases Product Name: AmbiVax-C

              Highest Development Status: Phase II Product Type: Vaccine

              Recipient: Biolexis

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Collaboration March 17, 2022

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              Akston Biosciences

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

              Details:

              AKS-452 is a SARS-CoV-2 vaccine candidate designed to induce a Th1/Th2 mixed immune response in patients against the Receptor Binding Domain of the novel coronavirus spike protein.

              Lead Product(s): AKS-452

              Therapeutic Area: Infections and Infectious Diseases Product Name: AKS-452

              Highest Development Status: Phase II Product Type: Vaccine

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 20, 2021

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

              Details:

              The Phase I trial showed AKS-452 to be safe and well-tolerated. Most importantly, AKS-452 produced a 100% seroconversion rate in the 90 microgram single-dose regimen, as well as in the 45 microgram two-dose regimen.

              Lead Product(s): AKS-452

              Therapeutic Area: Infections and Infectious Diseases Product Name: AKS-452

              Highest Development Status: Phase I/ Phase II Product Type: Vaccine

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable August 05, 2021

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              Akston Biosciences Announces Commercial Supply Agreement of Seppic’s Adjuvant to Formulate Akston COVID-19 Vaccine

              Details:

              AKS-452 is a protein subunit vaccine that is in Phase II testing at the University Medical Center Groningen (UMCG), one of the largest hospitals in the Netherlands.

              Lead Product(s): Engineered SARS-CoV-2-RBD-Fc Fusion Protein Vaccine

              Therapeutic Area: Infections and Infectious Diseases Product Name: AKS-452

              Highest Development Status: Phase I/ Phase II Product Type: Vaccine

              Recipient: Seppic

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Agreement July 21, 2021

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              Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
              One Pharma aims to be one of the leading generic companies in Europe.
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