SK bioscience and Vaxxas Enter Joint Development Agreement for Needle-Free Patch Delivery of Typhoid Vaccine

• SK bioscience and Vaxxas have officially entered into a Joint Development Agreement. This collaboration is set to revolutionize vaccine delivery by developing a novel vaccine-delivery device combination product using Vaxxas' high-density microarray patch (HD-MAP) platform technology with SK bioscience's proprietary typhoid vaccine. This groundbreaking initiative receives support from the esteemed global charitable foundation, Wellcome.
• The HD-MAP platform technology offers user-friendly vaccines, allowing possible self-administration. Its room temperature stability revolutionizes distribution, reducing costs and expanding vaccination access, particularly in lower- to middle-income countries.

SEONGNAM, South Korea, Aug. 23, 2023 /PRNewswire/ -- SK bioscience, an innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced today that the company has entered into a collaboration agreement with Vaxxas, an Australian biotechnology company developing a unique vaccine patch platform technology, to develop a second-generation typhoid conjugate vaccine with support from Wellcome.

SK bioscience's SKYTyphoid™ vaccine will be reformulated so that it can be 'printed' onto the thousands of tiny microprojections covering the Vaxxas patch to be delivered directly to the abundant immune cells just under the skin surface. This reformulation aims to enhance access and broaden markets where traditional intramuscular delivery using needle and syringe has been employed.

Under the agreement, SK bioscience will supply the antigen utilized by its typhoid conjugate vaccine, SKYTyhpoid™ that was jointly developed by SK bioscience and the International Vaccine Institute (IVI).

Vaxxas will be responsible for reformulating the SKYTyphoid antigen so that it can be applied to its proprietary HD-MAPs, and then conduct preclinical studies, which if successful, will be followed by a Phase I human clinical trial. The project is expected to be completed within two years from initiation to reporting the data from the Phase I clinical trial.

The project is being supported by approximately AU$5.4 million (GB£2.84 million / US$3.67 million) in grant funding received from Wellcome.

Wellcome is a global charitable foundation supporting discovery research into life, health and wellbeing, and action to take on mental health, infectious disease and climate and health. Their infectious disease programme supports projects to help increase understanding of the sources of disease and drivers of escalation, as well as accessible and affordable solutions to control the impact of infections.

SK bioscience collaborated with Wellcome and the IVI on the development of a trivalent invasive non-typhoidal Salmonellosis vaccine candidate in 2019. In October 2022, SK bioscience also signed a memorandum of understanding (MoU) with Hilleman Laboratories, a research institute established by MSD and Wellcome, for a strategic partnership to co-develop new vaccine candidates and technology platforms.

As Vaxxas' HD-MAPs deliver the vaccine directly to abundant immune cells in the skin, they hold the potential to be more immunogenic than traditional needle and syringe administration, and they offer the prospect of reduced dosing. Vaxxas' user-friendly applicator facilitates simplified self-administration accommodating individuals with varying skill levels.

Vaxxas' innovation to reformulate vaccines for application on HD-MAPs and subsequent drying can prevent drug deterioration and improve vaccine stability. This could allow storing and distributing vaccines at room temperatures, which is vital for making vaccines more accessible in lower- and middle- income countries with limited cold-chain distribution infrastructure.

SKYTyphoid is a polysaccharide-protein conjugate (Vi-DT) vaccine, formulated by conjugating the polysaccharide of Typhi, which serves as an antigen, to diphtheria toxin protein, which serves as a carrier.

SK bioscience received funding to develop SKYTyphoid from the Bill & Melinda Gates Foundation in the early stages of the development. Based on its immunogenicity and safety, SKYTyphoid obtained an approval for exportation from the Ministry of Food and Drug Safety (MFDS) in May 2022, and is expected to obtain WHO Prequalification this year.

Compared to a current polysaccharide vaccine, SKYTyphoid provides acceptable immunogenicity and long-term preventive effects with a single-dose administration. Furthermore, the vaccine can be administered to infants 6 months to 2 years of age.

Typhoid fever is a life-threatening infection caused by the bacterium Salmonella Typhi. It is usually spread through contaminated food or water. The disease continues to be a public health problem in many developing countries in Africa, Middle East, and Southeast where there is a continuing lack of clean water supply and lack of adequate sewage facilities.

According to the World Health Organization, an estimated 9 million cases of typhoid fever occur globally each year. Symptoms include prolonged high fever, fatigue, headache, nausea, abdominal pain, and constipation or diarrhea with mortality rates up to 30%.^[1]

Pierre Balard, Senior Research Manager at Wellcome said, "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. 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."

David L. Hoey, President and CEO of Vaxxas said "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. 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."

Jaeyong Ahn, CEO of SK bioscience said, "Typhoid fever is a dangerous disease that frequently occurs in low- and middle- income countries, but the utilization of typhoid vaccines has been limited due to the requirement for vaccines that remain stable under varying temperatures and those that can be administered without medical supervision. 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."

Notes to editors

Vaxxas and SK biosciences 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.

About SK bioscience

SK bioscience is a global 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.

For further information, please visit

- Official SK bioscience Homepage

- SK bioscience Linkedin

About Vaxxas

Vaxxas is a private Australian 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 disease and oncology, and currently has six clinical programs, including ones focused on Covid-19, Influenza and Measles Rubella.

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 commercialisation 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, Brandon BioCatalyst, and US-based HealthCare Ventures, followed by 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 vaxxas.com www.one-ventures.com and www.brandoncapital.vc.

About Wellcome  

Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we're taking on three worldwide health challenges: mental health, infectious disease and climate and health. 

Contact
SK bioscience Communications Team
Changhyun Jin([email protected])  
Jeannie S. Pak([email protected])  
Tae-Gyun Kim([email protected])

Wellcome Media Office
[email protected]
+44 (0)20 7611 8866

[1] Typhoid, the World Health Organization

SOURCE SK bioscience