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."

[1] The EncOVac consortium is led by Poolbeg in partnership with AnaBio Technologies (‘AnaBio’), University College Dublin (‘UCD’), and Trinity College Dublin (‘Trinity’).