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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 IIProduct Type: Vaccine

Partner/Sponsor/Collaborator: Stelis Biopharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Termination March 07, 2023

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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 IIProduct 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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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 IIIProduct 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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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 IIProduct 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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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 IIIProduct 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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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 IIProduct 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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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 IIProduct Type: Vaccine

Recipient: Biolexis

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration March 17, 2022

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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 IIProduct 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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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 IIProduct 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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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 IIProduct Type: Vaccine

Recipient: Seppic

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement July 21, 2021

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