Vaxxas to develop first room-temperature stable RSV vaccine with NIH license

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Vaxxas, a clinical-stage biotechnology company known for its innovative high-density microarray patch (HD-MAP) vaccination platform, has secured a worldwide license from the United States National Institutes of Health (NIH) for a next-generation vaccine antigen aimed at combating Respiratory Syncytial Virus (RSV). 

This breakthrough allows Vaxxas to develop the first needle-free, room-temperature stable RSV vaccine to enter clinical studies, the company said in a media release. 

The newly licensed antigen, referred to as DS2, has been engineered by scientists at the NIH’s Vaccine Research Center and the National Institute of Allergy and Infectious Diseases. 

It is designed to elicit a more robust and durable immune response against RSV compared to the currently approved vaccine antigen, DS-Cav1.

Published preclinical results show the potential immunogenic advantages of this next-generation antigen as the basis for an RSV vaccine that could offer more robust and durable protection against the virus, compared to vaccines already on the market,” stated David Hoey, president and CEO of Vaxxas. 

He further emphasised the significance of their technology, saying, “These advantages, coupled with our needle-free technology’s potential to eliminate the need for refrigerated distribution and enable self-administration, could offer a vaccine that makes a significant impact on the way we protect populations against this serious respiratory infection in the future.”

Vaxxas’ HD-MAP vaccine delivery system is progressing towards commercialisation, having completed five Phase I clinical trials involving over 500 participants. 

These trials include a second-generation COVID-19 vaccine candidate and a HD-MAP delivered flu vaccine, which has shown greater immunogenicity than its injectable counterparts.

Backed by funding from the United States Biomedical Advanced Research and Development Authority (BARDA), Vaxxas is currently conducting its first US IND-enabled Phase I clinical study for a pre-pandemic influenza vaccine with 258 participants. 

The company plans to move forward with its needle-free HD-MAP/RSV vaccine into a Phase I clinical study upon completing preclinical development.