Vaxxas Acquires Next-Gen RSV Vaccine from NIH

On October 28, 2024, Vaxxas, a biotechnology company with operations in both Brisbane, Australia, and Cambridge, Massachusetts, USA, announced a significant development in vaccine technology. Vaxxas has obtained a license from the United States National Institutes of Health (NIH) for a cutting-edge vaccine antigen called DS2. This antigen is tailored for use in vaccines aimed at preventing Respiratory Syncytial Virus (RSV).

The license granted to Vaxxas by the NIH allows the company to develop the first needle-free and stable-at-room-temperature RSV vaccine to enter clinical trials. The DS2 RSV vaccine antigen, developed by experts at the NIH’s Vaccine Research Center and the National Institute of Allergy and Infectious Diseases, is designed to elicit a stronger and longer-lasting immune response than the currently approved RSV antigen, DS-Cav1.

David L. Hoey, President and CEO of Vaxxas, highlighted the advantages of the new antigen in providing more robust and durable protection against RSV. He also emphasized the potential of Vaxxas’ needle-free technology to eliminate the need for cold storage and facilitate self-administration, which could significantly enhance vaccine accessibility and distribution.

Vaxxas’ innovative HD-MAP vaccine delivery platform has already shown promise, having successfully completed five Phase I clinical trials involving over 500 participants. These trials included a second-generation COVID-19 vaccine candidate, an HD-MAP delivered flu vaccine that demonstrated superior immunogenicity compared to traditional flu shots, and a measles and rubella vaccine.

Currently, Vaxxas is conducting its first U.S. IND-enabled Phase I clinical study for a pre-pandemic influenza vaccine, supported by funding from the United States Biomedical Advanced Research and Development Authority (BARDA). This study involves 258 participants. Following the completion of preclinical development, Vaxxas plans to advance its needle-free HD-MAP/RSV vaccine to a Phase I clinical trial.

Respiratory Syncytial Virus (RSV) is a widespread virus that affects the lungs and respiratory passages, causing significant global health burdens. Each year, RSV is responsible for approximately 33 million cases of acute lower respiratory infections, leading to around 3.6 million hospitalizations and over 101,400 deaths worldwide. The virus poses a particularly high risk to children aged 0-60 months, especially during the first six months of life. Adults with comorbidities, weakened immune systems, or advanced age are also at increased risk of severe RSV disease, which can exacerbate conditions like COPD, asthma, and chronic heart failure, potentially resulting in pneumonia, hospitalization, and death.

The approval of the first RSV vaccines, GSK’s AREXVY and Pfizer’s ABRYSVO, in 2023 marked a significant advancement in addressing the unmet medical needs associated with RSV.

Vaxxas’ HD-MAP technology consists of thousands of tiny projections on a small patch, each coated with a dried vaccine formulation. When applied to the skin using a simple applicator, the patch delivers the vaccine to immune cells located just beneath the skin’s surface. This method offers several benefits over traditional vaccine administration, including greater stability at higher temperatures, which reduces the need for cold-chain logistics.

HD-MAP vaccines have been shown to be safe and well-tolerated in numerous trials, often inducing equal or superior immune responses compared to traditional injections, even at lower doses. Additionally, HD-MAP vaccines are easier to administer, which could lead to higher acceptance among healthcare providers and patients. Ultimately, this technology could enable vaccines to be delivered directly to homes, workplaces, and schools, bypassing the delays and inconveniences associated with conventional vaccination methods.

Vaxxas, a private biotechnology company, aims to enhance the performance of existing and next-generation vaccines through its HD-MAP platform. The company has conducted several successful human clinical trials and is progressing toward commercialization. Founded in 2011 as a start-up by The University of Queensland’s commercialization group UniQuest, Vaxxas has received substantial support and funding from entities such as OneVentures Innovation Fund I, Brandon Capital Partners, and US-based HealthCare Ventures.