Globally, there are 3.2 million patients treated for end-stage renal disease (ESRD), a number increasing by 6% each year. A kidney transplant is the best hope for ESRD patients and can allow them to lead a normal life. Unfortunately, due to a lack of suitable donor organs, and the risks of transplant, most patients with kidney failure will never receive a transplant. These patients depend on dialysis to stay alive. Haemodialysis is the most common type of chronic dialysis, a procedure which is typically required 3x per week and involves pumping the patient's entire blood supply through an artificial kidney called a "dialyser", providing an artificial means of removing the fluid and waste products that healthy kidneys normally remove. Shockingly, life expectancy on dialysis is just one-third of normal, with half of patients receiving haemodialysis dying from cardiovascular complications. Stress and damage to cardiovascular health during the haemodialysis procedure is caused by inflammatory processes initiated by the patient's innate immune system which recognises the dialysis membrane as a large foreign body and attacks it. Although the damage from a single haemodialysis session is slight, the repetitive nature of the procedure generally leads to more profound damage, complications, and death. The inflammation is also associated with the flu-like symptoms commonly experienced after dialysis, which are often highly debilitating for patients, significantly reducing their quality of life. Invizius Limited are developing the H-Guard technology to address this long-standing and critical healthcare need. H-Guard is a novel medical device coating technology which acts like an 'invisibility cloak' to hide the dialysers from the immune system and prevent the inflammatory processes. By preventing the immune response and ensuing inflammation, H-Guard will significantly reduce cardiovascular damage, extend haemodialysis patient life expectancy and reduce healthcare costs associated with hospitalisations and the treatment of cardiovascular complications. This project aims to deliver a First-in-Human study to assess the safety and performance of (acute) H-Guard administration as a priming solution to coat dialysers and blood tubing sets during the standard clinical dialysis set-up prior to use in haemodialysis patients. Outcomes from this project will enable Invizius to progress rapidly through further clinical studies to gain regulatory approval in Europe by 2026\.

Home-based dialysis offers considerable benefits to patients, is less expensive than in-centre dialysis, and is much more profitable for dialysis manufacturers. However, serious side effects cause complications which limit treatment durability. Invizius Limited is a Scottish biotechnology company focused on transforming dialysis care with novel solutions that reduce dialysis-induced complications and improve patient outcomes. This project focuses on the development of a solution for home-based dialysis that aims to reduce the therapy's effects and prolong its usefulness. If successful, the product will lead to significant quality of life gains for patients, substantial savings for healthcare payers and economic growth for dialysis equipment manufacturers.

Recombinant protein expression is the keystone manufacturing technique supporting production of many biological therapies. A large number of protein expression systems exist, but the majority of biological drugs and protein products that are approved for clinical use have been manufactured using mammalian cell culture techniques. These manufacturing processes are laborious, slow, and expensive. Yeast systems offer a significantly simpler way of expressing recombinant proteins at scale compared to mammalian cell culture, and at a greatly reduced cost. A number of yeast protein expression systems have been commercialised. However, the baker's yeast (Saccharomyces cerevisiae) expression systems, which are most commonly used in industry for biologics production, have never themselves been widely commercialised by the companies that developed them. The patent protection for these baker's yeast systems has now expired or is expiring. This engenders considerable freedom to create new systems and develop new IP surrounding enhanced, second-generation protein expression systems utilising S. cerevisiae as their protein-production powerhouse and making this technology widely available to new companies wishing to bring recombinant products to the market. The project will enable Phenotypeca to develop novel strains of S. cerevisiae to be created that can be quickly and easily tailored to optimize production of recombinant proteins. In this instance, the platform will be exemplified by producing a protein (H-Guard) for another UK SME - Invizius - which is a coating used on dialysis equipment to prevent inflammatory responses induced by repeated exposure to dialyser membranes. Invizius will work alongside the Centre for Process Innovation (CPI), who join the consortium as grant funded partners to conduct industrial fermentation modelling to identify the most suitable for scale-up production. The project supports Phenotypeca to become a service provider for clients wanting S. cerevisiae-based protein expression systems. There are currently no commercial providers of industrial S. cerevisiae systems -- all S. cerevisiae systems used industrially are proprietary systems developed in-house by other companies who don't want to share their technology of offer a development service. Phenotypeca is attempting to overcome the unmet market need for S. cerevisiae protein expression systems, especially for a class of therapeutic peptides for which Pichia pastoris-based yeast systems cannot meet the quality and regulatory requirements.