Needle-free can increase immunogenicity, reduce costs, and improve patient experience
GOLDEN, Colo. — July 19, 2022 — PharmaJet® , a company who has developed and commercialized a needle-free platform to more effectively administer drugs and biologics, today announced that they will present their latest research results at the mRNA-Based Therapeutics Summit on July 27, 2022. The presentation, entitled Advances in mRNA vaccines and therapeutics delivery with PharmaJet Needle-free Injection Systems, will be presented by Carmen Ledesma-Feliciano, DVM, PhD, DACLAM, Clinical Device Specialist at PharmaJet. This event, which takes place in Boston, will convene mRNA experts to highlight emerging tools and technologies that support the development of scalable and commercially viable mRNA-based therapeutics.
PharmaJet Needle-free Injection Systems (NFIS) are increasingly being incorporated into preclinical and clinical studies across multiple nucleic acid vaccine and therapeutic development programs. This presentation will highlight several partner studies that show the benefits of the PharmaJet NFIS including improved immunogenicity, dose-reduction, lower cost, and better patient and healthcare worker experience. These will include:
- Gennova: This study1 shows the benefit of using the Tropis device over needle and syringe (N/S) administration and underscores the dose-sparing capabilities of ID delivery with Tropis compared to IM delivery. The binding antibody and T cell responses of a COVID-19 self-amplifying mRNA vaccine were evaluated in a guinea pig pre-clinical model using multiple doses, and intramuscular (IM) and intradermal (ID) delivery with the PharmaJet Tropis® System and N/S. The low dose Tropis group produced significantly increased B and T cell responses compared to a higher dose IM N/S vaccination.
- CureVac: This phase 1 trial2 shows that delivery with the PharmaJet NFIS provides superior results, with titers elicited above the WHO threshold after initial vaccination with an immune memory response. The study measured the safety and effectiveness of a rabies mRNA-protamine complexed vaccine, comparing multiple doses, routes (IM and ID) and methods of delivery (N/S and other NFIS).
- United States Army Medical Research Institute of Infectious Diseases(USAMRIID): This study3 shows that delivery of lipid nanoparticle (LNP)-formulated mRNA constructs with the Stratis® NFIS induces higher antibody production of monoclonal antibodies with neutralizing activity against smallpox
when compared to N/S. Three mRNA constructs encoding different monoclonal antibodies were tested, alone and in combination, delivered with the Stratis IM System and N/S.
- PharmaJet/Colorado State University – VandeWoude Laboratory: This study1 showed that the PharmaJet Systems can be used to safely deliver mRNA-LNP formulated vaccines without disrupting immunogenicity. A COVID-19 vaccine was administered to rabbits in mRNA and mRNA-LNP formulations, testing multiple doses, routes (IM and ID), and delivery methods (Tropis, Stratis, and N/S). PharmaJet is developing the next set of studies to further characterize and improve mRNA-LNP vaccine delivery over N/S.
“Our partners continue to publish results showing that the PharmaJet Needle-free Systems deliver mRNA vaccines safely and induce immune responses comparable or better than N/S,” said Chris Cappello, President and Chief Executive Officer, PharmaJet, Inc.
For more information about PharmaJet visit www.pharmajet.com.
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2 Alberer M, Gnad-Vogt U, Hong HS, et al. Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: an open-label, non-randomised, prospective, first-in-human phase 1 clinical trial. Lancet. 2017;390(10101):1511-1520. doi:10.1016/S0140-6736(17)31665-3
3 Mucker EM, Thiele-Suess C, Baumhof P, Hooper JW. Lipid nanoparticle delivery of unmodified mRNAs encoding multiple monoclonal antibodies targeting poxviruses in rabbits. Mol Ther Nucleic Acids. 2022;28:847-858. Published 2022 May 10. doi:10.1016/j.omtn.2022.05.025
PharmaJet’s mission is to enable greater access to life improving pharmaceuticals. We are committed to helping our partners realize their research and commercialization goals while making an impact on public health. PharmaJet’s Needle-free Injection Systems provide increased vaccine effectiveness, a preferred patient and caregiver experience, and a proven path to market. 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. For more information visit www.pharmajet.com. Follow us on LinkedIn.