Poolbeg Pharma Regulatory News (POLB)

Poolbeg Pharma Plc

Oral Vaccine Programme Moves Forward

Next Generation Oral Vaccine Programme Advancing Through Non-Dilutive Funding

22 June 2023 - Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, 'Poolbeg' or the 'Company'), a clinical-stage biopharmaceutical company focusing on infectious and other prevalent diseases with high unmet medical needs, announces an update to its Oral Vaccine Programme following the award of non-dilutive grant funding by the Irish Government's Disruptive Technologies Innovation Fund ("DTIF") in November 2022, as part of the Poolbeg led EncOVac Consortium[1]. Having finalised the research plan and all consortium members completing the Consortium and Grant Agreements, the EncOVac Consortium parties are now entering the next phase to commence the validation of the encapsulation process. The validation is expected to complete in H2 2023.

Taking place over three years, the EncOVac Consortium is funded to develop a Phase I clinical trial ready oral vaccine candidate. The agreed research plan includes several stages of work and once the encapsulation process, developed by AnaBio Technologies, has been successfully validated, the consortium will proceed to encapsulate vaccine antigen candidates developed by Associate Professor Siobhán McClean at University College Dublin ('UCD') together with adjuvants identified by Professor Ed Lavelle at Trinity College Dublin. This oral vaccine candidate will then complete all required non-clinical testing in preparation for a Phase I clinical trial.

Poolbeg's Oral Vaccine Programme will possess the capability to generate vaccines for a wide range of diseases and represents a significant commercial opportunity. The platform has the potential to be licensed to partners or developed internally within Poolbeg, positioning the Company to help tackle a broad range of infectious diseases, which has the potential to make a positive impact on public health.

Dr. Jeremy Skillington, Chief Executive Officer of Poolbeg, commented: "The validation of the encapsulation process is a key step in the creation of a Phase I clinical trial ready oral vaccine candidate and Poolbeg is proud to lead the EncOVac Consortium. Delivering oral vaccines to the gut has the potential to revolutionise global protection against infectious disease. In contrast to intramuscular vaccines that generate systemic immunity, oral vaccines induce mucosal immunity, which can induce better protection against pathogens at the site of infection."

Dr. Aidan Fitzsimons, Chief Executive Officer of AnaBio Technologies, remarked "This is a very exciting step in the development of next generation vaccines. With the EncOVac consortium, and in partnership with Poolbeg, UCD and Trinity, we can develop effective oral vaccine candidates that can provide a more accessible and efficient solution to preventing a range of infectious diseases."

Associate Professor Siobhán McClean, UCD School of Biomolecular and Biomedical Science, said, "Having worked in the fields of chronic infection and vaccine development for many years, this consortium has the potential to be immensely beneficial for the development of oral vaccines. By triggering mucosal immunity, we can target the areas where pathogens enter the body, resulting in more effective and long-lasting protective responses, benefitting both patients and public healthcare systems."

Professor Ed Lavelle, Professor of Vaccine Immunology at Trinity College Dublin, added "The COVID-19 pandemic has highlighted the need for innovative approaches to vaccine development. The EncOVac consortium's focus on oral vaccines has the potential to address the key challenges associated with vaccination against mucosal pathogens by inducing local immune responses at the site of infection. By developing an effective oral vaccine candidate, we can improve accessibility and reduce the burden on healthcare systems, while also providing more effective protection against infectious diseases."

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About Poolbeg Pharma

Poolbeg Pharma specialises in the development of innovative medicines to address the unmet need in infectious and other prevalent diseases. Poolbeg has a disciplined portfolio approach to mitigate risk, accelerate drug development, and enhance investor returns. The Company simultaneously advances multiple programmes in cost-effective clinical trials, rapidly generating early human safety and efficacy data to enable early partnering / out-licensing, with the funds generated reinvested in the pipeline. Poolbeg also uses AI to interrogate human challenge trial data sets to quickly identify new targets and drugs, and in-license near or in the clinic medicines, leading to faster development and greater commercial appeal.

The Company is targeting the growing infectious disease market. In the wake of the COVID-19 pandemic, infectious disease has become one of the fastest growing pharma markets and is expected to exceed $250bn by 2025. Through opportunistic identification of assets which complement Poolbeg's existing pipeline, the Company is progressing programmes in oncology and metabolic syndromes; adding disease areas with significant addressable markets.

With its initial assets from hVIVO plc (formerly Open Orphan plc), an industry leading infectious disease and human challenge trials business, Poolbeg has access to knowledge, experience, and clinical data from over 20 years of human challenge trials. The Company is using these insights to acquire new assets as well as reposition clinical stage products, reducing spend and risk. Amongst its portfolio of exciting assets, Poolbeg has a small molecule immunomodulator for severe influenza and other acute inflammatory conditions (POLB 001) which produces a highly significant reduction in p38 MAP kinase driven cytokines in a clinical setting; a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002); and a vaccine candidate for Melioidosis (POLB 003). The Company is also developing two Oral Delivery Programmes and is progressing two Artificial Intelligence (AI) Programmes to add promising new assets to its pipeline.

For more information, please go to www.poolbegpharma.com or follow us on Twitter and LinkedIn @PoolbegPharma.

About AnaBio Technologies

AnaBio Technologies is a specialist microencapsulation company, focused on improving health and performance through micro-encapsulation of sensitive bioactive ingredients for food, beverage and pharmaceutical applications. Founded in 2011 by Dr Sinead Bleiel, and based in Carrigtwohill Co Cork, AnaBio has developed into a global leader in the field of micro encapsulation with 15 patent families and clients across N America, Asia, and EU.

Bioactives and APIs clearly bestow health benefits, but are vulnerable to being inactivated by environmental stresses encountered during processing, storage and digestion. This can result in limited quantities of intact active bioactives reaching the site of action in the body, and no health benefit.

Microencapsulation represents a sophisticated delivery system designed to overcome this problem. A protective coat is created at microscopic level around the bioactive or API which protects the ingredient from a wide range of environmental conditions, enables its release at the appropriate site within the body, and thereby ensures that the potential health benefits of the bioactive are fully realised. AnaBio Technologies offers its clients a range of services including contract research to develop bespoke microencapsulation solutions, commercial scale manufacture and supply of microencapsulated ingredients and licensing of its patented microencapsulated technology.

For further information, visit www.anabio.ie or email aidan.fitzsimons@anabio.ie.

About University College Dublin ("UCD")

UCD is Ireland's largest and most diverse university and one of Europe's leading research-intensive universities. Since 1854 UCD has made a unique contribution to the creation of modern Ireland, based on successful engagement with Irish society on every level and across every sphere of activity. As Ireland's leading university in innovation, knowledge transfer and commercialisation, UCD's commitment to innovation and entrepreneurship recognises the importance of active participation and collaboration to exploit leading-edge research and development outputs. As set-out in Rising to the Future 2020-2024 UCD's four strategic themes are; creating a sustainable global society, transforming through digital technology, building a healthy world, and empowering humanity.

For further information, visit www.ucd.ie

About Trinity College Dublin ("TCD")

Trinity College Dublin, founded in 1592, is Ireland's oldest university. Today it has a vibrant community of over 20,000 students and is recognised internationally as Ireland's premier university, currently 98th in the QS University World Rankings. Cutting edge research, technology and innovation places the university at the forefront of higher education in Ireland and globally. It encompasses all major academic disciplines, and is committed to world-class teaching and research across a range of disciplines in the arts, humanities, engineering, science, social and health sciences. Trinity is Europe's leading university for graduate entrepreneurship and has placed innovation and entrepreneurship at the heart of its strategy - from the development of plans for a new innovation campus at Grand Canal Quay, to the establishment of the University Bridge I and University Bridge Fund II.

For further information, visit www.tcd.ie