Public Funding for Ailsevax Limited

The success of mRNA vaccines against SARS-CoV-2 highlights the revolutionary capabilities of this technology. Its efficacy in combatting other diseases like malaria and respiratory syncytial virus is also ground-breaking, and these advancements are now helping to fuel the development of mRNA-based vaccines targeting cancer. However, despite their promise, current mRNA vaccines also face limitations that hinder their efficacy and increase their manufacturing costs. We have developed a breakthrough approach for enhancing vaccine efficiency, which we have termed Antigen-to-Surface Enhancement Technology (ASET). Inclusion of ASET in an mRNA vaccine dramatically increases its effectives. ASET is a highly versatile technology that can be used to improve the efficacy of mRNA vaccines against a wide range of diseases, including infectious diseases and cancer, and can also be applied to DNA-based vaccines. It is also a cost-effective technology, as it can reduce the amount of mRNA required in each vaccine formulation. Benefits of ASET include: * Enhanced effectiveness of mRNA and DNA vaccines. * Reduced potential for reactogenic side-effects. * Broad adaptability to existing and novel vaccines across a range of infectious diseases and cancer. * Reduced production costs (lower cost-of-goods). ASET is currently in the preclinical stage of development. In this project, we aim to optimise the ASET prototype and assess its effectiveness against cancer and viral pathogens. The results obtained in this Biomedical Catalyst project will establish ASET as a break-through technology that will be incorporated into the development of the next generation of mRNA and DNA vaccines.

AilseVax Ltd is a vaccine-focussed company developing new innovations in vaccine design and formulation. AilseVax is a spinout micro-company from Queen's University Belfast trading in Belfast. Up to this point, AilseVax has been focussed on the generation of novel cancer vaccines. In the lead up to this current application, AilseVax has developed an exciting new nanoparticle adjuvant that has the potential to be used broadly in the vaccine field; an adjuvant is a component used in many vaccines that helps create a stronger immune response. Our new adjuvant can not only be used in cancer vaccines, but also larger global markets such as infectious diseases. This is because our novel adjuvant nanoparticle can be simply added to vaccine formulations, irrespective of the disease or type of vaccine. Our preclinical studies have demonstrated that our nanoparticle adjuvant can elicit enhanced vaccine-induced immunogenicity, generating stronger immune activation than standard adjuvants. In this project, we aim to optimise the manufacturing and scaling up of our nanoparticle prototype and confirm that nanoparticles produced by an optimised, scalable process can maintain their adjuvant effects. To help us achieve this aim, AilseVax will work the Centre for Process Innovation (CPI), a UK catapult with expertise and cutting-edge technologies that it applies to advance next generation therapeutic modalities. CPI will develop a methodology for generating the nanoparticle adjuvant using a scalable and pharmaceutically-relevant manufacturing process. The AilseVax team will analyse the physiochemical properties of the nanoparticles CPI generate and assess their adjuvant effects in a number of vaccine formulations. The outcomes from this project will be a scalable manufacturing process for the novel nanoparticle adjuvant. Achievement of this outcome will remove a major commercialisation barrier to the technology, allowing the late preclinical and clinical development of the technology in vaccine formulations under development by AilseVax and downstream commercial partners.

The COVID pandemic has unsurprisingly awakened new interest in the power of vaccine technologies. One disease area where vaccination holds particular promise is cancer. Cancer remains a major problem, with one in every two people in the UK now predicted to get cancer in their lifetimes. This has a considerable impact on individual lives and livelihoods, exerts extreme pressures on our stretched healthcare system, and represents a significant economic burden on our society. AilseVax Ltd is a spin-out company from the Queen's University Belfast focused on the development of novel cancer vaccine technologies with broad applicability for the treatment of multiple cancers, which avoid the need for individual personalised vaccine design and have potential to augment efficacy of immunotherapies. Current cancer vaccine development is focussed on highly personalized cancer vaccines, where, upon diagnosis, the individual patient's tumour genome is sequenced, compared to the patient's normal blood for identification of tumour-specific mutations, then putative neo-antigens are manufactured into a completely bespoke vaccine. Whilst this approach has yielded therapeutic effects, it is complex, lengthy, and exceptionally costly and therefore prohibitively expensive to implement in most international healthcare settings, including the NHS. Our overall goal is to develop a novel cancer vaccine discovery pipeline based on the premise that abnormalities in gene expression in cancers leads to expression of tumour-specific vaccine targets (antigens), which are common and predictable across a range of tumour types in different patients. This is enabled by a novel technology platform that leverages cutting-edge sequencing and data analysis methods that allow us to identify novel "cryptic" targets for cancer vaccines that have not been looked at before. These antigens can form the basis of next-generation vaccines, where immunization of patients will trigger a tumour-selective immune response towards these abnormal cells. This novel, broad-spectrum cancer vaccine approach will be cheaper, simpler to manufacture (scalable) and easier to use clinically compared to completely individualized vaccines being developed by competitors. This is because our approach has potential for a single vaccine to have broad application across a range of tumour types (and therefore patients). These "broad spectrum" vaccines will have better cost-benefit ratios and have the potential to be more widely adopted due to their broad applicability to multiple rather than individual patients, improving therapeutic outcomes for drug resistant and recurrent cancers where there are clear clinical and thus market needs.