MMS019

Virpax Announces MMS019 Manufacturing and Supply Agreement

Retrieved on: 
Thursday, August 26, 2021
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The agreement with Seqens provides for both the supply material for Virpaxs clinical studies as well as the long-term commercial supply of MMS019.

Key Points: 
  • The agreement with Seqens provides for both the supply material for Virpaxs clinical studies as well as the long-term commercial supply of MMS019.
  • Seqens will conduct process development and validation of additional large scale commercial quantities of MMS019 at its facilities in Devens and Newburyport, Massachusetts.
  • Establishing a collaboration with a strong partner capable of supplying clinical and commercial scale quantities of MMS019 is another important advancement in our MMS019 product development strategy.
  • Seqens has a demonstrated expertise in developing and manufacturing highly-complex molecules for large scale production, said Anthony Mack, Chairman and CEO of Virpax.

Virpax® Pharmaceuticals Receives FDA Response and Guidance on MMS019

Retrieved on: 
Tuesday, August 17, 2021
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Virpax believes the results of the pre-IND response support further research on MMS019 as an intranasal protective that may limit transmission of the viruses to others.

Key Points: 
  • Virpax believes the results of the pre-IND response support further research on MMS019 as an intranasal protective that may limit transmission of the viruses to others.
  • Virpax expects to move forward and pursue a New Drug Application (NDA) for MMS019 as a once daily intranasal treatment.
  • The FDA has indicated that Virpax may pursue an NDA drug approval with the Office of Non-Prescription Drugs.
  • We believe that the initial pathway to move forward with the development of MMS019 has been clarified, said Anthony P. Mack, Chairman and CEO of Virpax.