Public Funding for Vascversa Ltd

VascVersa is developing an innovative cell therapy designed to revolutionize the treatment of chronic non-healing wounds, specifically focusing on diabetic foot ulcers (DFU). Despite extensive medical research, current available treatments fall short, with a staggering 39% of treated wounds failing to heal, primarily due to insufficient blood supply. This presents a significant healthcare challenge both in the UK and globally, affecting nearly half a million individuals in the UK alone. These wounds not only inflict substantial pain and hardship on sufferers but also hinder their ability to engage in work. Left untreated, the condition can escalate to limb amputation, significantly reducing life expectancy. Beyond the personal toll, this places a tremendous financial strain on the NHS, exceeding £1 billion annually. These challenges are amplified on a global scale, as the diabetic population is projected to surge to almost 400 million by 2030\. In diabetic patients with non-healing wounds or ulcers, the process of vascular healing is compromised. VascVersa's breakthrough product, Angicyte, tackles this issue by stimulating the formation of new blood vessels. Collaborative research with Queen's University Belfast has confirmed Angicyte's effectiveness in promoting blood vessel repair. These specialized cells are derived from umbilical cord blood, and with the right laboratory conditions, a single cord blood donation can be swiftly expanded to yield sufficient cells for treating a large patient population. We can create highly pure therapeutic cells that will be used as a new therapy to enhance wound healing. Over the next 18 months, VascVersa, alongside partners, the Scottish National Blood Transfusion Service (SNBTS) and the Cell and Gene therapy Catapult (CGTC)and Advanced Therapy Treatment Centre (ATCC) will standardise manufacture to generate Angicyte to clinically ready doses. VascVersa is committed to future-proofing Angicyte production by developing strategies around the cell banking and using innovative technologies to enable scalable production. We will also will also finalise the product formulation to enable ease of application by a nursing team and ensure Angicyte to fits into the current clinical care pathway. In parallel, we will build a support team of clinical experts, to allow us to engage with the NHS and NICE to discuss product reimbursement and pricing. This IUK project will lay strong foundations and allow the development of our unique cell therapy in preparation for the landmark FIH clinical trial planned for 2026\.

VascVersa is developing a radical new cell therapy called Angicyte for the treatment of ischaemic diseases (diseases characterised by lack of blood supply). Angicyte promotes the formation of new blood vessels and induces vascular healing, therefore will be of benefit for multiple vascular diseases. Research by the company and Queen's University Belfast has established that Angicyte may benefit retinal ischaemia by rescuing retinal blood vessels. Ischaemic retinopathies are a major cause of blindness. This group of disorders are characterised by changes in the retinal microvasculature leading to inadequate blood supply which damages the normal retinal vessels and induces pathological alterations, leading to blindness if left untreated. Despite decades of research, there is no cure for retinal ischaemia. Current treatments such as anti-VEGFs, steroid injections and laser therapy target only late stages of the disease when pathological changes have already occurred. This condition profoundly impacts patients' quality of life and limits their ability to work and drive. These retinopathies are an enormous healthcare burden in the UK and globally, and the prevalence of diabetic retinopathy continues to increase as rates of type two diabetes rise. The global population living with diabetic retinopathy is estimated to reach 174 million in 2045\. The financial burden for the NHS is greater than £60 million annually and it is predicted to cost more than £96 million by 2035\. Cell therapies are emerging as exciting new treatments for diabetic retinopathy. A vascular therapy such as Angicyte has the potential to revascularise and rescue the ischaemic retina. In this 8-month project, VascVersa will work with MediNect, a Northern Irish company specialising in preclinical models of eye diseases, with the goal to examine the potential of Angicyte for ischaemic retinopathies. These experiments will: evaluate whether Angicyte therapy is beneficial; establish the best dosing and delivery strategy; and analyse the safety of Angicyte for retinal delivery. This project will allow VascVersa to make a major step in developing this second disease indication for Angicyte, and the data generated from this project will form the foundation for meeting with the regulatory bodies for a later clinical trial. Having a second disease indication for Angicyte therapy will be of huge benefit to VascVersa and allow the company to grow as a leading cell therapy developer in Northern Ireland.

VascVersa is developing a revolutionary new cell therapy for the treatment of chronic non-healing wounds, in particular diabetic foot ulcers (DFU) and leg ulcers. Despite immense medical research, current available treatments are inadequate and 39% of treated wounds still fail to heal, largely due to a lack of blood supply. Diabetic ulcers remain an enormous healthcare burden in the UK and globally. Almost half a million people in the UK are suffering these painful and difficult to heal wounds. This condition profoundly affects the quality of life of sufferers and limits their ability to work. If left untreated, the condition can lead to limb amputation and reduced life expectancy. As well as the socioeconomic costs, the financial burden for the NHS is enormous, over £1 billion each year. These issues are repeated worldwide and are getting worse as the number of people with diabetes increases -- the global diabetic population is estimated to reach 578 million by 2030\. Vascular healing is defective in a diabetic patient with a non-healing wound or ulcer. VascVersa's product, Angicyte, is a cell therapy which will address this by promoting the formation of new blood vessels. Research by the company and at Queen's University Belfast has established that Angicyte can promote blood vessel repair. Angicyte cells are generated from donated umbilical cord blood. Under the right laboratory conditions, each cord blood donation can be rapidly expanded to provide enough cells to treat large numbers of patients. In this 24-month project, VascVersa will work with some of the UK's leading research institutions specialising in cell therapy to prepare for its first clinical trial. As well as completing further pre-clinical research required by the regulatory authority, the MHRA, to prove the efficacy and safety of the product, the project will allow VascVersa to develop a robust, clinically compatible, more automated manufacturing process, which will be a major step towards large scale production of Angicyte for use in the clinic. VascVersa will also obtain regulatory advice on its development plans at a scientific advice meeting with the MHRA, all of which will support VascVersa, to achieve the objective of conducting its first clinical study in 2025\.

"VascVersa (Versatile Vascular Stem Cells for Regenerative Medicine) Cardiovascular diseases are the top cause of death worldwide. There is an urgent need to find new treatments to repair damaged blood vessels as current approaches are not optimal. At VascVersa, we are committed to develop innovative regenerative medicine, and we have optimised a consistent way to manufacture highly pure vascular stem cells from a sample of blood. Our unique method of generation produces a stem cell therapy product ANGICYTE, of top quality with higher purity and superior growth capacity, when compared to other available cell products. These vascular stem cells can be grown up in our laboratory to provide large numbers for treatment. As all tissue repair requires blood supply, ANGICYTE can be harnessed to target areas of blood vessel injury and promote repair of damaged blood vessels. We have experimental evidence that our Vascular stem cells can be used as a cellular therapy promoting new blood vessel formation. We are developing a novel cell therapy product ANGICYTE for regenerative medicine. In the first phase, we will use ANGICYTE to target wound healing as it was a key area of demand identified in our market research (through the ICURe programme) and includes diabetic ulcers, pressure ulcers, burns, wounds, and chronic non-healing ulcers; however, ANGICYTE can also be applied to other vascular diseases in the heart, brain, and limbs, and this will be the focus of our second phase. This Innovate UK grant will provide much needed start-up funding to allow us to spin out our company, develop our technology into a clinical grade product and meet with regulatory agencies that will guide the future development of these stem cells to effectively treat patients."