PharmaJet Tropis Intradermal Delivery System is Now Authorized for Two Nucleic Acid Vaccines

• First human DNA vaccine
• First in class thermostable self-amplifying mRNA vaccine

GOLDEN, Colo.--(BUSINESS WIRE)--PharmaJet^®, a company engineering precision delivery systems that overcome challenges of nucleic acid vaccine delivery, today announced that its Tropis^® System is now the exclusive intradermal delivery system for two authorized novel Covid-19 vaccines:

1. The previously announced world’s first plasmid DNA Covid-19 vaccine for administration in humans from Zydus Lifesciences (ZyCoV-D), is exclusively delivered with Tropis based on pre-clinical and clinical study results that showed increased immune response of the vaccine translating into clinical effectiveness of ZyCoV-D.
2. The world’s first self-amplifying mRNA-based Omicron-specific Covid-19 booster vaccine from Gennova Biopharmaceuticals (GEMCOVAC-OM) to achieve emergency use authorization, allows a low dose of the first room temperature stable mRNA vaccine.

Tropis ID has already been used for millions of injections in multiple immunization campaigns worldwide. Data has repeatedly shown improved immunogenicity for nucleic acid vaccines and therapeutics compared to needle and syringe and electroporation delivery.¹ This improved immunogenicity translated into efficacy demonstrated for the DNA vaccine ZyCov-D and to non-inferior immune response to COVISHIELD for the GEMCOVAC-OM samRNA vaccine.

Chris Cappello, President, and CEO, PharmaJet added, “This marks an important milestone for PharmaJet in that we now have two commercially available nucleic acid-based vaccines in India being exclusively delivered with the Tropis Precision Delivery System™. We are well-prepared to rapidly support the demand and look forward to advancing our partnerships and are committed to supporting the advancement of mRNA and DNA vaccines targeting a variety of infectious disease applications for global public health benefit.”

Dr. Sanjay Singh, CEO of Gennova Biopharmaceuticals remarked, “The thermostable mRNA- booster vaccine - GEMCOVAC-OM is delivered by the PharmaJet Precision Delivery System, an innovative and highly effective intradermal delivery device that has the added advantages of being safe and needle-free.”

PharmaJet has a broad portfolio of 26 ongoing clinical studies, with over 80 global pharmaceutical partnerships. Areas of focus are infectious diseases and immuno-oncology including COVID-19, HPV, Flu, Hantavirus, as well as cervical cancer, melanoma, and leukemia.

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¹ Improved DNA Vaccine Delivery with Needle-Free Injection Systems

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.

About Tropis

The PharmaJet Tropis^® ID Precision Delivery System™ was developed with support from the World Health Organization, US CDC, and the Bill & Melinda Gates Foundation and has CE Mark and WHO PQS certification for intradermal injections. It has been used for millions of injections in multiple immunization campaigns worldwide. Data has repeatedly shown improved immunogenicity for nucleic acid vaccines and therapeutics administered with Tropis compared to needle and syringe and electroporation delivery. In addition, Tropis is the exclusive intradermal delivery system for two authorized novel Covid-19 vaccines: ZyCoV-D by Zydus Lifesciences, and GEMCOVAC-OM by Gennova Biopharmaceuticals.