Nature Publication Highlights the Benefits of Tropis® Intradermal When Used to Administer a First-in-Class Self-Amplifying mRNA Vaccine
April 24 2024 - 10:10AM
Business Wire
- Delivery of a novel self-amplifying mRNA (samRNA)-based vaccine
with Tropis ID System directly into the dermis significantly boosts
immune responses.
- This study shows that intradermal (ID) delivery of a samRNA
vaccine with liquid nano-emulsion is safe and well-tolerated.
- GEMCOVAC®-OM samRNA vaccine is a low dose, room temperature
stable mRNA vaccine that was licensed under emergency use
authorization in 2023.
PharmaJet®, a company that strives to improve the performance
and outcomes of medicines with its innovative delivery systems,
today announced the Nature publication1 of Gennova
Biopharmaceutical’s Phase 2/3 clinical trial conducted to evaluate
the safety and immunogenicity of its novel samRNA-based Covid-19
vaccine booster. The results demonstrated that GEMCOVAC-OM,
administered exclusively with Tropis, is well-tolerated with no
related serious adverse events and significantly boosts immune
responses against the Omicron variant. Furthermore, the publication
cited that the self-amplifying, thermostable mRNA platform
delivered intradermally with Tropis provides a framework for
next-generation vaccines that can improve accessibility and global
equity.
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The PharmaJet pioneering technology
unlocks the rich potential of the human dermis, paving the way for
enhanced immune responses. (Graphic: Business Wire)
ID delivery is known to have the potential to improve the
performance of vaccines, but this study is the first time a samRNA
vaccine has been developed with a lipid nano-emulsion, and the data
show that ID administration of this vaccine is safe and
well-tolerated. Tropis unlocks the rich potential of the human
dermis, paving the way for enhanced immune responses. Vaccine
delivery directly into the dermis enables access to the immune
system, with benefits on durability and breadth of immune response,
and mucosal immunity. Tropis also enables access to immune cell
populations more directly thus creating the potential for dose
sparing.
PharmaJet has partnered with Gennova to improve the performance
and outcomes of their samRNA platform with PharmaJet’s breakthrough
ID delivery technology. The outcome of this collaboration is a
needle-free self-amplifying vaccine with advantages over the other
mRNA vaccines approved for COVID-19:
- GEMCOVAC-OM is a lyophilized vaccine, stable at 2-8°C, which
means it can be distributed through the existing refrigeration
supply chain. The booster vaccine is exclusively administered
intradermally with Tropis.
- Tropis leverages the rich network of dendritic cells,
macrophages, and T cells in the dermal layer providing a more
potent and broader immunogenic response than vaccinating into the
muscle. Tropis is prequalified by the WHO and approved by numerous
regulatory bodies globally. As a needle-free delivery System,
Tropis eliminates the need for sharps disposal and needle-stick
injuries, as well as increases coverage due to its high
acceptability among caregivers and healthcare workers.
“We congratulate our partner Gennova for their compelling data
published in this prestigious journal,” said Chris Cappello,
President, and Chief Executive Officer, PharmaJet. “This new data
adds to the evidence base indicating Tropis needle-free ID
administration is an enabler for vaccine platforms.”
Tropis ID (for intradermal administration) and Stratis® SC/IM
(for intramuscular and subcutaneous administration) are the only
commercially scaled needle-free technologies that enhance the
performance of several vaccines and therapeutics. PharmaJet has
over 80 global development partners and Tropis has been used to
perform over 10 million vaccinations in several countries.
For more information about PharmaJet visit
https://pharmajet.com.
Refer to Instructions for Use to ensure safe
injections and to review risks.
1 An Omicron-specific, self-amplifying mRNA booster vaccine for
COVID-19: a phase 2/3 randomized trial | Nature Medicine
About PharmaJet
The PharmaJet mission is to improve the performance and outcomes
of medicines with our innovative delivery systems that better
activate 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 increased vaccine effectiveness, allow for a
preferred patient and caregiver experience, and offer 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 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.
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Nancy Lillie Nancy.Lillie@pharmajet.com 1-888-900-4321 Option
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