This license will enable Vaxxas to prepare for clinical trials of the first respiratory syncytial virus (RSV) vaccine delivered to the skin using Vaxxas’ new high-density microarray patch (HD-MAP). This next-generation vaccine antigen (DS2), licensed to Vaxxas for use worldwide, is more potent and durable against RSV compared to the antigen used in globally approved vaccines (DS-Cav1). Developed and optimized by NIH scientists to stimulate a sexually-specific immune response. RSV is a contagious virus that is a common cause of respiratory illness around the world, particularly affecting young children and the elderly, and can cause severe illness and death. Vaxxas’ proprietary HD-MAP provides needle-free vaccination, eliminates cold storage, and enables self-administration, making future vaccine distribution and administration less costly, more effective, and easier to distribute and administer. It becomes something that facilitates.
BRISBANE, Australia and CAMBRIDGE, Mass.–(BUSINESS WIRE)–Vaxxas, a clinical-stage biotechnology company commercializing a novel high-density microarray patch (HD-MAP) vaccination platform, today announced The US National Institutes of Health announced the following: (NIH) has granted the company a license for a next-generation vaccine antigen (DS2) designed for use in a prophylactic vaccine against respiratory syncytial virus (RSV).
A global license from the NIH enabled Vaxxas to develop the first needle-free, room-temperature-stable RSV vaccine to enter clinical research.
Vaxxas’ licensed next-generation DS2 RSV vaccine antigen is being developed by the NIH Center for Vaccine Research to promote a more robust and durable immune response to RSV compared to antigens used in currently approved vaccines. Developed by scientists at the National Institute of Allergy and Infectious Diseases. (DS-Cav1).
“Published preclinical results demonstrate the potential immunogenicity of this next generation antigen as the basis for an RSV vaccine that can provide stronger and more durable protection against the virus compared to vaccines already on the market. and demonstrate the benefits of sex,” said President David L. Hoey. The CEO of Baxus said: “These benefits, combined with the potential of our needle-free technology to eliminate the need for refrigerated distribution and enable self-administration, will have a significant impact on how we protect people from this serious respiratory infection in the future. Vaccines may be available.”
Vaxxas’ HD-MAP vaccine delivery platform is on track for commercialization, with five Phase I clinical trials involving more than 500 participants completed, and the second-generation COVID-19 vaccine candidate, HD- It has had successes, including showing higher immunogenicity than influenza vaccines delivered through MAP. Approved injectable vaccine comparators and measles and rubella vaccines.
The company is currently conducting the first US IND-enabled Phase I clinical study of a pre-pandemic influenza vaccine involving 258 participants, with funding from the US Biomedical Advanced Research and Development Authority (BARDA). .
After completing preclinical development of the product, Baxus plans to advance the needle-free HD-MAP/RSV vaccine into Phase I clinical studies.
About respiratory syncytial virus (RSV)
RSV is a common contagious virus that affects the lungs and respiratory tract. The global burden of RSV is significant, causing an estimated 33 million cases of acute lower respiratory tract infections annually, an estimated 3.6 million RSV-related hospitalizations, and more than 101,400 RSV-related deaths annually. There is.
Respiratory syncytial virus contributes significantly to morbidity and mortality in children aged 0 to 60 months, especially up to 6 months of age, worldwide. Adults may be at increased risk of RSV disease due to comorbidities, immunocompromised status, or advanced age. RSV can worsen conditions such as COPD, asthma, and chronic heart failure, and can lead to severe outcomes such as pneumonia, hospitalization, and death.
The approval of the world’s first RSV vaccines, GSK’s AREXVY and Pfizer’s ABRYSVO, in the United States and Europe in 2023 marks an important milestone in addressing the severe unmet medical need associated with RSV. It became.
About HD-MAP needle-free vaccine
Vaxxas HD-MAP consists of thousands of microscopic protrusions molded into small patches. Each microprotrusion is coated with a small amount of vaccine in a dry formulation. When applied to the skin using a unique, easy-to-use applicator, the patch delivers the vaccine to the abundant immune cells that naturally reside just below the skin’s surface.
HD-MAP vaccine administration has many potential advantages over traditional vaccine administration methods. For example, vaccines in dry form are more stable at higher temperatures than vaccines in liquid formulation, potentially reducing the need for cold chain storage and distribution.
Vaxxas’ HD-MAP has been proven safe and tolerable in hundreds of clinical trial participants and has been shown to induce immune responses comparable to or better than vaccines injected at lower doses. It has been. Compared to needle and syringe systems, HD-MAP vaccines are also much easier to administer and are more likely to be accepted by healthcare professionals and patients/subjects.
Ultimately, HD-MAP will enable a future in which vaccine patches can be shipped directly to people’s homes, workplaces, and schools, eliminating the delays, inconvenience, and safety associated with scheduling and administering traditional needle-and-syringe vaccines. issue may be avoided.
About Vaxas
Vaxxas is a privately held biotechnology company focused on improving the performance of existing and next-generation vaccines using proprietary HD-MAPs. Vaxxas is targeted for initial applications in infectious diseases and oncology.
It has been successful in several completed human clinical trials involving over 500 participants. Additional ongoing Phase I clinical studies in seasonal influenza and COVID-19. Other vaccine research targeting pandemic influenza is being conducted with funding from the US Biomedical Advanced Research and Development Agency (BARDA), and Baxus’ HD-MAP vaccine delivery platform is moving toward commercialization.
Vaxxas’ core technology was originally developed at the University of Queensland (UQ) and the company was established as a start-up company in 2011 by UQ’s commercialization group UniQuest. The company was founded after completing an initial equity financing led by OneVentures Innovation Fund I with co-investors Brandon Capital Partners and US-based HealthCare Ventures, followed by further funding led by OneVentures. , the latest round of funding includes UQ.
OneVentures Innovation Fund I and Brandon BioCatalyst are supported by the Australian Government’s Innovation Investment Fund (IIF) program. IIF is the Australian Government’s venture capital initiative, which provides investment capital and management expertise to portfolio companies through accredited venture capital fund managers. For more information, visit OneVentures and Brandon Capital.
Note
The vaccine provided by Vaxxas HD-MAP is under investigation and available for investigational use only. It cannot be sold or purchased anywhere in the world. Accordingly, Vaxus does not claim that its vaccines are reliable, durable, reliable, safe or effective, or that they are superior to other vaccines or vaccine delivery technologies.
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Vaxas – For the US:
Kathryn Morris
yates network
+1 914 204 6412
kathryn@theyatesnetwork.com
Vaxas – Australia:
amy miller
WE communication
+61 431 072 422
amymi@we-worldwide.com
