PharmaJet’s Needle-free System to be used in Australian Clinical COVID-19 Trial
By: Colorado BioScience Association Date: 10/07/2020
PharmaJet®, the maker of innovative, needle-free injection technology, today announced that its Stratis® Needle-free Injection System will be used to deliver a vaccine against SARS-CoV-2 in a clinical trial in Australia. The DNA-based vaccine COVIGEN was developed by French-Thai pharmaceutical company BioNet and Melbourne-based biotech Technovalia. The Phase 1 trial is a joint collaboration between Australia’s most experienced vaccine trial sites including the University of Sydney, the Telethon Kids Institute in Perth, the University of Adelaide, the Vax4COVID alliance, and with multi-million dollars financial support of Australia’s Medical Research Future Fund. The PharmaJet System was chosen due to its record of increasing the efficacy of DNA vaccines, and speed of the delivery system compared to traditional needle and syringe.
The collaboration team has developed COVIGEN, a novel DNA-based vaccine against COVID-19, which to date has shown to be safe and effective in pre-clinical trials. This funding will allow researchers to move to a Phase 1/1b clinical trial to test the vaccine’s safety and effectiveness amongst 150 healthy volunteers. Findings from the trial will inform evaluation of the vaccine in future larger Phase 2 and 3 trials.
The University of Sydney’s Associate Professor, Nick Wood commented, “DNA vaccine technology is both new and promising. With this type of vaccine, it is especially important to get it inside human cells, which makes the PharmaJet Stratis Needle-free System an ideal delivery method. Additionally, because there are no needles there are no sharps waste to dispose of, or risk of needlestick injury.”
“We are pleased to be collaborating with BioNet-Asia and their partners as they move into human clinical trials,” commented Chris Cappello, President and CEO, PharmaJet. “Our Needle-free Systems provide the platform to get vaccines directly into cells to help maximize target gene expression in the body. Our findings from multiple clinical studies with other DNA vaccines have resulted in improved efficacy using our devices.”1
“We are glad that our collaboration with PharmaJet has led to the rapid development of a DNA vaccine which will enter soon in a human trial conducted by an alliance of clinical experts in Australia. This validates our years of development on recombinant vaccines and our DNA technology platform,” added Hong Thai Pham, CEO, BioNet.
For more information about PharmaJet visit www.pharmajet.com.
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1 Data on file
PharmaJet’s mission is worldwide acceptance of PharmaJet Needle-free Injection Systems as a standard of care in the vaccine delivery market. The PharmaJet Needle-free Systems are safe, fast, and easy-to-use. They eliminate needlestick injuries, needle reuse and cross contamination, and help reduce sharps waste disposal. 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. For more information visit www.pharmajet.com.
BioNet is a French-Thai fully-integrated Biotech company focusing on the discovery, manufacturing and supply of innovative life-saving vaccines. BioNet is the world’s only manufacturer of recombinant pertussis-only vaccine (Pertagen®, aP vaccine) and a TdaP recombinant vaccine (Boostagen®), containing a genetically-inactivated pertussis toxin (PTgen). BioNet has built several strategic alliances fostering vaccine self-reliance leading to the supply of billions of doses of vaccines. The company has many ongoing collaborative projects on the development of recombinant and nucleic acid vaccines. BioNet and Pasteur Institute (France) are developing a DNA vaccine against Dengue and Zika diseases. Leveraging on its expertise in recombinant DNA technology, BioNet produced rapidly clinical lots of SARS-CoV-2 gene-based vaccine (COVIGEN), which will be administered with PharmaJet needle-free injector in a human trial by end 2020. For more information, visit www.bionet-asia.com or email firstname.lastname@example.org.