Vaxxas Awarded US$3.67 million (AU$5.4 million) from global charitable foundation, Wellcome, for Human Clinical Study of Typhoid Vaccination using Needle-Free Vaccine Patch

• Funding from Wellcome will further broaden Vaxxas’ diverse clinical pipeline of next-generation vaccines to include Typhoid fever.
• Program will be jointly developed in collaboration with SK bioscience, a global leader in vaccine development.

CAMBRIDGE, Mass. & BRISBANE, Queensland, Australia–(BUSINESS WIRE)–Vaxxas, a clinical-stage biotechnology company commercializing a novel vaccination platform, today announced that the global charitable foundation, Wellcome, has made an award totaling US$3.67 million (AU$5.4 million / GB£2.84 million) to conduct IND-enabling studies and a first-in-human clinical study for a potentially second generation typhoid vaccine delivered by Vaxxas’ proprietary high-density microarray patch (HD-MAP) platform technology. The project is expected to be completed within two years.

The typhoid vaccine formulation used to coat the HD-MAP will be based on SKYTyhpoid™, an approved typhoid conjugate vaccine that was jointly developed by Vaxxas’ collaborator in this project, SK bioscience, and the International Vaccine Institute (IVI). The typhoid vaccine product candidate used in these studies will be formulated to be more stable at higher temperatures than required for needle and syringe vaccination.

Improved thermostability of vaccine products is a key benefit offered by Vaxxas’ HD-MAP platform, and has the potential to reduce the cost and complexity of cold-chain distribution and storage – both significant barriers to vaccine accessibility in lower and middle income countries. The HD-MAP also has the benefit of potentially requiring less training to administer and even self-administration. As such, success in this endeavor has the potential to increase global access to the life-saving typhoid vaccine.

Typhoid fever is a life-threatening systemic infection caused by the bacterium Salmonella enterica serovar Typhi (commonly known as Salmonella Typhi) which is usually spread through the ingestion of contaminated food or water.

According to the World Health Organization, an estimated 9 million people globally are infected by the disease each year. Of this, approximately 110,000 people die from the disease, mostly in lower income countries, and disproportionately children, where water quality and hygiene are compromised.

“To help protect more people at risk from deadly diseases like typhoid fever, new vaccine innovations are needed to improve access and ensure equitable coverage,” Pierre Balard, Senior Research Manager at Wellcome, said. “Vaxxas’ high-density microarray patch (HD-MAP) is an important step in this direction. With the potential to overcome some of the most enduring barriers to vaccine access in lower income countries, this product could be a vital addition to our global toolkit.”

Vaxxas is committed to advancing multiple clinical programs to further validate the significant benefits its HD-MAP platform can bring to a range of vaccines for major diseases. This project continues to build on the progress of its HD-MAP technology in human clinical studies with other vaccine candidates including COVID-19 and influenza.

“We are excited to be initiating this important work with Wellcome and SK bioscience to leverage our HD-MAP vaccine platform to potentially enhance typhoid vaccination,” said David L. Hoey, President and CEO of Vaxxas. “We believe our HD-MAP can play a critical role in extending the global reach of typhoid conjugate vaccines, and make a significant difference to the lives of many.”

SK bioscience, who also provide vaccines for flu, shingles and chickenpox, received funding to develop its SKYTyhpoid™ vaccine initially from the Bill & Melinda Gates Foundation. Based on its immunogenicity and safety, SKYTyhpoid™ obtained an approval for exportation from the Minister of Food and Drug Safety (KMFDS) in May 2022, and is expected to obtain WHO Prequalification this year.

SKYTyhpoid™ is expected to provide acceptable immunogenicity and long-term preventive effects with a single-dose administration. Furthermore, the vaccine can be administered to infants six months to two years of age.

“Typhoid fever is a dangerous disease that frequently occurs in lower- and middle-income countries due to poor water quality and hygiene, but typhoid vaccines have not been widely used due to the need for them to be thermostable and administered by a doctor,” SK bioscience CEO Jaeyong Ahn said. “This collaboration with Vaxxas provides an opportunity to overcome those challenges. We will continue to develop various formulations and products that can contribute to human health based on cross-border cooperation with international organizations and institutions, such as Wellcome and Vaxxas.”

About Vaxxas

Vaxxas is a privately held biotechnology company focused on enhancing the performance of existing and next-generation vaccines with its proprietary high-density microarray patch (HD-MAP). Vaxxas is targeting initial applications in infectious diseases and oncology.

With success in several completed human clinical trials involving more than 500 participants; additional ongoing Phase I clinical studies for COVID-19 and seasonal influenza; and other vaccine studies targeting pandemic influenza, funded by the United States Biomedical Advanced Research and Development Authority (BARDA), and a measles-rubella study funded by the Bill & Melinda Gates Foundation, expected to start in 2024, Vaxxas’ HD-MAP vaccine delivery platform is advancing rapidly toward commercialization.

Vaxxas’ core technology was initially developed at The University of Queensland (UQ), and the company was established as a start-up in 2011 by UQ’s commercialization group UniQuest. The company was founded with the completion of an initial equity financing led by OneVentures Innovation Fund I with co-investors Brandon Capital Partners and US-based HealthCare Ventures, followed by a further financing led by OneVentures with UQ joining the most recent financing.

OneVentures Innovation Fund I and Brandon BioCatalyst are supported by the Australian Government’s Innovation Investment Fund (IIF) program. The IIF is an Australian Government venture capital initiative that provides investment capital and managerial expertise through licensed venture capital fund managers to investee companies. Learn more at www.one-ventures.com and www.brandoncapital.vc.

About HD-MAP needle-free vaccines

The Vaxxas high-density microarray patch (HD-MAP) is made up of thousands of microscopic points attached to a small patch. Each of these micro-projections contains a tiny dose of vaccine in a dried formulation. When applied to the skin, the patch delivers the respective vaccine to the abundant number of immune cells that naturally reside immediately below the skin surface.

HD-MAP vaccine delivery offers many potential benefits over more traditional ways of administering vaccines. For example, the dried form of the vaccine is more stable at higher temperatures than vaccines in liquid formulations, therefore reducing the need for cold-chain storage and distribution.

Vaxxas’ HD-MAPs have proven safe and tolerable in hundreds of trial participants to date, and have been shown to induce equal or greater immune responses to injected vaccines at lower doses. Compared with needle and syringe systems, they are also much easier to administer and are likely to have greater acceptability.

Ultimately, HD-MAP patches could enable a future in which vaccine patches could be mailed directly to peoples’ homes, workplaces and schools, avoiding the delay and inconvenience of traditional needle-and-syringe vaccine scheduling and administration.

About Wellcome

Wellcome supports science to solve the urgent health challenges facing everyone. It supports discovery research into life, health and wellbeing, and takes on three worldwide health challenges: mental health, infectious disease and climate and health.

About SK bioscience

SK bioscience is an innovative vaccine and biotech company, standing committed to global pandemic preparedness in vaccine development and manufacturing to create more equitable access to vaccines. In leveraging strengths on cutting-edge vaccine development technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. Under collaborations of domestic and international governments, regulatory agencies, healthcare providers, doctors and medical experts, SK bioscience has firmly established globally certified R&D and manufacturing technologies. All of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions. Learn more at SK bioscience.

Note to Editor

Vaxxas and SK bioscience have recognised that Wellcome is supporting the project in order to address the burden of infectious diseases (such as typhoid) by developing new treatments which are affordable and available to those most in need, whilst also being commercially viable for the companies involved. As a condition of Wellcome’s funding, future commercialisation of any typhoid product developed with this funding will be subject to global access requirements to allow low- and middle-income countries to access those products. A share of any revenue from future private commercial sales of the respective product (not public and/or Gavi supplies) will also come back to Wellcome for further investment in science to solve urgent health challenges.

Caution

Vaxxas’ HD-MAP delivered vaccines are under investigation and available only for investigational uses. They are not available anywhere in the world for sale or purchase. As such, Vaxxas makes no claim that the vaccines are reliable, durable, dependable, safe, or effective, and makes no claim that it is superior to any other vaccine or vaccine delivery technology.

Contacts

Media

Vaxxas – In United States:
Kathryn Morris

The Yates Network

+1 914 204 6412

kathryn@theyatesnetwork.com

Vaxxas – In Australia:
Amy Miller

WE Communication

+61 3 8866 1235

+61 431 072 422

amymi@we-worldwide.com

Wellcome Media Office:

+44 (0)20 7611 8866

mediaoffice@wellcome.org

SK bioscience Communications Team:

Changhyun Jin (jin99@sk.com)

Jeannie S. Pak (J.pak@sk.com)

Tae-Gyun Kim (taegyunkim@sk.com)