Clinical-stage biotechnology company Vaxxas, which is commercialising a novel high-density microarray patch (HD-MAP) vaccination platform, has announced that the US National Institutes of Health (NIH) has granted the company a licence to a vaccine antigen candidate designed for use in prophylactic vaccines against Respiratory Syncytial Virus (RSV).
Vaxxas said its worldwide licence from the NIH for the candidate, DS2, enables the company to develop the first needle-free, room-temperature stable RSV vaccine to enter clinical studies.
The DS2 RSV vaccine antigen candidate licensed by Vaxxas was developed by scientists at the NIH’s Vaccine Research Centre and the National Institute of Allergy and Infectious Diseases to prompt a more robust and durable immune response against RSV.
"Published preclinical results show the potential immunogenic advantages of this antigen candidate as the basis for an RSV vaccine to provide robust and durable protection,” said Vaxxas CEO David Hoey. “These potential advantages, coupled with the potential of the Vaxxas needle-free technology 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 platform is advancing toward commercialisation, with five successful Phase 1 clinical trials involving more than 500 participants completed, including a COVID-19 vaccine candidate, a HD-MAP delivered flu vaccine, and a measles and rubella vaccine.
With funding from the United States Biomedical Advanced Research and Development Authority (BARDA), the company is currently conducting its first US IND-enabled Phase I clinical study for a pre-pandemic influenza vaccine involving 258 participants in Australia.
Vaxxas intends to progress the needle-free RSV vaccine antigen candidate to a Phase 1 clinical study after completing preclinical development of the product.