PharmaJet Announces U.S. Government Award Expansion to Clinically Assess a DNA Vaccine Combined with its Systems

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The expansion award, worth over $4 million, will be used to further advance the clinical assessment of its Venezuelan Equine Encephalitis Virus (VEEV) DNA candidate vaccine in combination with either Tropis Intradermal (ID) or Stratis Intramuscular (IM) Systems.

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Tuesday, April 18, 2023
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Biotechnology, Medical Devices, Infectious Diseases, Health, Pharmaceutical, Stratis, Injection, United States Army Medical Research Institute of Infectious Diseases, DNA, Human, Partnership, Use, Alphavirus, U.S. Department of Defense Strategy for Operating in Cyberspace, USAMRIID, Licensure, Venezuelan equine encephalitis virus, DTRA, ID, Epidemic, Investigational New Drug, PDS, CGMP, Mortality, NHP, Defense Threat Reduction Agency, Encephalitis, IND, Infection, Pharmaceutical industry, Vaccine
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COLORADO, UNITED STATES, NORTH AMERICA
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PHARMAJET
Summary
Key Points: 
  • The expansion award, worth over $4 million, will be used to further advance the clinical assessment of its Venezuelan Equine Encephalitis Virus (VEEV) DNA candidate vaccine in combination with either Tropis Intradermal (ID) or Stratis Intramuscular (IM) Systems.
  • Venezuelan Equine Encephalitis Virus is an alphavirus that causes encephalitis and potential mortality in infected humans and equines.
  • It is listed as a potential biothreat agent with no approved human vaccine or therapeutic currently available.
  • PharmaJet is working with a contract manufacturer to produce the cGMP VEEV plasmid DNA vaccine and is preparing the Investigational New Drug (IND) application.


PharmaJet®, a company engineering Precision Delivery Systems™(PDS) that overcome the challenges of vaccine delivery, today announced that it received a scope expansion and 3-year extension of its multi-year agreement with the Joint Science and Technology Office of the U.S. Defense Threat Reduction Agency (DTRA). The expansion award, worth over $4 million, will be used to further advance the clinical assessment of its Venezuelan Equine Encephalitis Virus (VEEV) DNA candidate vaccine in combination with either Tropis Intradermal (ID) or Stratis Intramuscular (IM) Systems.

Venezuelan Equine Encephalitis Virus is an alphavirus that causes encephalitis and potential mortality in infected humans and equines. It is listed as a potential biothreat agent with no approved human vaccine or therapeutic currently available.

DNA vaccination has proven particularly effective at eliciting protective immune responses against alphavirus challenge.1 Most recently, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and PharmaJet found in a non-human primate (NHP) challenge study that a prime and single boost by either the intramuscular (Stratis) or intradermal route (Tropis) resulted in humoral and cellular immune responses that provided significant protection against VEEV disease and viremia.2 These results paved the way for advancing the candidate vaccine into human trials. The Phase 1 study, sponsored by PharmaJet, aims to identify the optimal dose and precision delivery system most suitable for use in subsequent broader clinical evaluations of the VEEV DNA vaccine candidate, with the ultimate goal to bring this vaccine to licensure.

PharmaJet is working with a contract manufacturer to produce the cGMP VEEV plasmid DNA vaccine and is preparing the Investigational New Drug (IND) application. Clinical site selection is in progress with an anticipated study start in Q3.

Chris Cappello, President and CEO, PharmaJet, said, “PharmaJet aims to contribute to the development of biothreats countermeasures not only to protect military positions and strategies but to increase government’s ability to combat disease in naturally occurring epidemics caused by these organisms. VEEV belongs to this category of biothreats that is on our watch. We are pleased to further our partnership with Defense Threat Reduction Agency within the U.S. Department of Defense, and we look forward to the clinical results of this promising DNA vaccine candidate with our commercially available needle-free precision delivery systems.”

For more information about PharmaJet visit https://pharmajet.com.

Refer to Instructions for Use to ensure safe injections and to review risks.

1 Lundstrum, K, Plasmid DNA-Based Alphavirus Vaccines, Vaccines (Basel), 2019 March; 7(1):29

2 Suschak, J. et al, A DNA vaccine targeting VEE virus delivered by needle-free jet injection protects macaques against aerosol challenge, npj Vaccines 7, 46 (2022)

About PharmaJet

The PharmaJet vision is to enable greater access to life-saving vaccines and pharmaceuticals globally. We are committed to helping our partners realize their research and commercialization goals while making an impact on public health. PharmaJet Precision Delivery Systems™ provide increased vaccine effectiveness, a preferred patient and caregiver experience, and a proven path to commercialization. They are also safe, fast, and easy-to-use. The Stratis® System has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. The Tropis® System has CE Mark and WHO PQS certification for intradermal injections. They are both commercially available for global immunization programs. For more information visit https://pharmajet.com. Follow us on LinkedIn.

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