Improving the outcome of pig studies in development of drugs and vaccines

At the heart of the project is the pig as an animal model. While mice have traditionally been the go-to for preclinical testing, they often fail to mimic the complex immune responses and infection pathways seen in humans. The consequence is failed clinical trials due to drugs and vaccines not performing optimally in humans. The pig, on the other hand, shares key physiological and immunological traits with humans, making it a promising model for more accurate and translatable results.

Urinary tract infections (UTI) are among the most common bacterial infections worldwide, affecting more than 150 million people each year. They are also a major driver of antibiotic consumption in both humans and animals. Despite significant effort by the industry and academia in developing new antimicrobials and vaccines against UTI, effective products that prevent in particular recurrent UTIs are still lacking. 

The IMPACT team will establish a platform of laboratory assays and analytical tools that work in pig models. The goal is to develop a more human-like testing ground for antimicrobial therapies and vaccines targeting UTIs. This platform can also be adapted to other infections in the future. 

“The pig model we developed in 2017 has shown remarkable potential,” says project lead Thomas Emil Andersen. “With this open project, we aim to develop an assay platform for pigs to support development of drugs and vaccines. The openness will help us clearly to demonstrate - to a wider community - how we can benefit from the strengths of the pig model.” 

In the initial phase, the IMPACT team will focus on developing tools to: 

• More accurately detect the subtle differences in the performance of prototype drugs and vaccines 

• Monitor the course of infection in ways that are comparable to human data 

• Identify immune markers in blood that predict vaccine protection in pigs that can be translated to efficacy in humans 

“Our goal is to identify how we can use the pig model as a reliable human-relevant model to evaluate vaccine success,” explains Kristian Stærk, an IMPACT team member based at Odense University Hospital. Kristian coordinates the pig studies and underlines the importance of the IMPACT project: “This kind of insight are very valuable prior to clinical trials.” 

Vaccine prototypes from the Danish company GlyProVac have over the past 5 years been tested in the pig model in close collaboration with Thomas Emil Andersen and Kristian Stærk. “In 2019 we decided to base our UTI vaccine development on the pig UTI model. Collaborating with SDU and OUH on this model platform provided a unique chance for optimizing the vaccine composition that was not possible in traditional small-animals” says Anders Boysen, CEO of GlyProVac. “With the analysis toolbox developed for pigs in IMPACT, preclinical research and development in this animal will be further strengthened, ultimately leading to drugs and vaccines that simply work better in humans”.   

Ultimately, the team hopes the assay developed in IMPACT can become a valuable tool for pharmaceutical companies and contract research organizations (CROs), helping them avoid costly failures in clinical trials. Better preclinical predictions will mean stronger lead candidates and more efficient drug pipelines. 

The IMPACT assays will also deepen our understanding of how infections evolve and how immune systems react. This understanding will open new doors to next-generation therapies that go beyond antibiotics, for instance targeting virulence or boosting the host’s natural defenses. The knowledge may also help improving urological products such as catheters to reduce device-associated UTIs. 

”We have seen promising results for our pipeline immune-stimulating drugs against UTI in mice, but the key to truly effective drugs also in humans goes through the pig model. We are excited to contribute to IMPACT and strengthen the effort to realize also non-antibiotic approaches against UTI” says Peter Olofsson-Sahl, CEO of Inicure, Sweden.  

Lene Feldskov Nielsen from Coloplast, another company partner in IMPACT, adds: “We’ve worked with SDU for years to understand urinary tract infection pathogenesis, in particular UTIs related to the use of catheters. This project is an exciting next step. It aligns closely with our mission to keep on improve our intermittent catheters to reduce complications for catheter users where UTIs are common.”

IMPACT is funded by ODIN, which encourages data and tool sharing between academia and industry – and with the public in general. This open collaboration enables rapid progress and ensures that outcomes can benefit other research areas as well. 

“I’m thrilled to bring in our assay development expertise and infrastructure for the IMPACT project,” says Yaseelan Palarasah, who also co-coordinates Denmark’s Monoclonal Antibody Center (MADE). “This kind of openness is essential for real innovation.” 

As an added benefit, the pig-specific assay developed during the IMPACT and downstream solutions against UTI, may also serve an entirely different sector such as the pig farming industry. Urinary tract infections are a common issue in pig herds, with around half of all sows affected, requiring a considerable use of antibiotics in this industry.  A urinary tract infection vaccine tested and validated in pigs could find use in this industry as well, reducing overall antibiotic consumption to help fight resistance in both human and animal health. 

• Thomas Emil Andersen (University of Southern Denmark) 
  Pioneer of the pig urinary tract infection model and project lead.
• Louise Kruse Jensen (University of Copenhagen)
  Expert in pig histopathology and bladder tissue analysis.
• Yaseelan Palarasah (University of Southern Denmark)
  Immunoassay specialist, head of SDU’s hybridoma lab, and co-coordinator of MADE - Monoclonal Antibody Center Denmark.
• Kristian Stærk (Odense University Hospital)
  Clinical urinary tract infection expert and pig model coordinator.
• Lene Feldskov Nielsen (Coloplast A/S, Denmark)
  Longstanding collaborator on urinary tract infection research, who will support the translational studies.
• Anders Boysen (GlyProVac, Denmark)
  Provides samples and expertise in immune-cell assays and mucosal antibody measurement.
• Luuk Hilgers (Litevax NV, The Netherlands)
  Specialist in vaccine adjuvants and pig immune responses.
• Peter Olofsson-Sahl (Inicure)
  Brings immune-stimulating compounds and assay development know-how.

You can read more about the IMPACT project right here