GOLDEN, Colo.--(BUSINESS WIRE)--PharmaJet®, a company that strives to improve the performance and outcomes of injectables with its enabling needle-free technology, today announced their upcoming poster presentation on November 13, 2024 at the International mRNA Health Conference 2024. The PharmaJet poster (#32), entitled Modulating Immune Responses to mRNA Vaccines Using Needle-Free Delivery Technologies, will be presented by Dr. Carmen Ledesma-Feliciano, DVM, PhD, DACLAM, Scientific Affairs Manager, PharmaJet. The conference brings together industry and academic professionals to explore the rapidly advancing science and business of mRNA medicines and features poster presentations highlighting the latest advancements in mRNA technology.
PharmaJet Needle-free Delivery Systems can improve delivery of mRNA vaccines and have been successfully adopted into multiple vaccine development programs while demonstrating a favorable safety profile and immunogenicity that is robust, durable, and often enhanced when compared to needle and syringe (N/S) delivery. The poster presentation will highlight three partner-published studies using the Tropis® Intradermal (ID) and/or Stratis® Intramuscular/Subcutaneous (IM/SC) Needle-free Injection Systems:
- Self-amplifying mRNA (samRNA) lipid nano-emulsion (LNE): The safety profile of GEMCOVAC®-OM COVID-19 vaccine administered intradermally with Tropis was assessed in Phase 2 and 3 studies in comparison to a ChADOx1 nCoV-19 adenoviral vector vaccine administered with N/S (IM). Immunogenicity data supported a favorable safety profile, leading to the Emergency Use Authorization (EUA) GEMCOVAC-OM in India, the world’s first samRNA-LNE vaccine to be approved for use in humans, delivered exclusively with Tropis.1
- mRNA-protamine: A first in-human Phase 1 trial compared multiple methods of delivery for a prophylactic mRNA rabies vaccine candidate, including Tropis ID, Stratis IM, and N/S (ID/IM). Participants vaccinated with the Tropis and Stratis Needle-free Injection Systems showed strong immune responses, developing virus-neutralizing antibodies, while N/S failed to induce a detectable antibody response in nearly all participants across several dose and route groups.2
- mRNA-LNP: Tropis was used to administer luciferase mRNA-LNP to study the effect that jet injection would have on mRNA-LNP compared to N/S, via bench and in vivo expression assays. While other characterization parameters remained largely similar, Tropis injection shifted the particle size distribution toward a larger size compared to N/S. However, in vivo expression with Tropis delivery trended higher than N/S. This showed that, despite some biophysical differences after injection, Tropis delivery did not affect in vivo expression of mRNA-LNP.3
“PharmaJet Needle-Free Systems enable mRNA vaccine delivery and the data from these published studies show how needle-free delivery has been successfully adopted into multiple vaccine development programs,” noted Nathalie Landry, Chief Scientific Officer, PharmaJet. “The needle-free technology is safe and well tolerated and induces immune responses that are robust and durable.”
For more information visit the PharmaJet website at https://pharmajet.com.
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1 Saraf, et al (2024). An Omicron-specific, self-amplifying mRNA booster vaccine for COVID-19: a phase 2/3 randomized trial. Nat Med, 30(5), 1363-1372.
2Alberer, et al (2017). Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: An open-label, non-randomised prospective, first-in-human phase 1 clinical trial. The Lancet, 390(10101) 1511-1520.
3 Meyer, et al (2024). Evaluation of luciferase and prefusion-stability F protein from respiratory syncytial virus mRNA/LNPs in pre-clinical models using jet delivery compared to needle and syringe. Vaccine X, 16, 100420.
About PharmaJet
The PharmaJet mission is to improve the performance and outcomes of injectables with our enabling technology that better activates the immune system. We are committed to helping our partners realize their research and commercialization goals while making an impact on public health. PharmaJet Precision Delivery Systems™ can improve vaccine effectiveness and promote a preferred patient and caregiver experience while being 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 or if you are interested in partnering with PharmaJet to improve the impact of your novel development program, visit https://pharmajet.com or contact PharmaJet here. Follow us on LinkedIn.
ABOUT International mRNA Health Conference
The International mRNA Health Conference (Conference Days, 12-14 November 2024) is the premier meeting destination for industry and academic professionals to explore the rapidly advancing science and business of mRNA medicines. The mRNA Health Conference provides participants an opportunity to learn more about developments in mRNA technologies through scientific presentations by some of the most esteemed experts in the field and extensive networking opportunities. The event brings together over 900 attendees from both academic institutions and leading pharma and biotech companies. The 2024 conference will be available virtual and on-site in Boston at the Hilton Boston Park Plaza Hotel.
