Poolbeg Pharma plc

Poolbeg-led consortium awarded €2.3m in non-dilutive funding to progress Oral Vaccine Platform

Transformative oral vaccine platform funded by the Disruptive Technologies Innovation Fund

15 November 2022 - Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, 'Poolbeg' or the 'Company'), a clinical stage infectious disease pharmaceutical company with a unique capital light clinical model, announces that 'EncOVac', a consortium led by Poolbeg Pharma, has been awarded €2.3m in non-dilutive grant funding to progress its Oral Vaccine Platform under the Irish Government's Disruptive Technologies Innovation Fund ('DTIF').

Taking place over three years, the collaboration between Poolbeg Pharma, University College Dublin, Trinity College Dublin and AnaBio Technologies will result in the development of an oral vaccine candidate to a Phase I ready state. The resulting technology will serve as a platform for additional oral vaccine candidates for a wide range of pathogens, initially targeting bacterial infections. Poolbeg is proud to play a role in the development of the next generation of vaccine technologies that can protect the world from infectious diseases.

Poolbeg licensed AnaBio's microencapsulation and nanoencapsulation technologies for use in the development and commercialisation of oral vaccines in January 2022. By delivering vaccines to the gut, oral vaccines can trigger 'mucosal immunity' that results in a protective response in the areas of the body where a pathogen would be inhaled or ingested such as the nose and digestive tracts. In comparison to intramuscular injections which generate systemic immunity, this approach prevents infections from taking hold in the body by counteracting them at the point of entry. This has the effect of both reducing transmission and preventing serious disease. Oral vaccines also offer an efficient method of administration and significantly reduce challenges for distribution, addressing the gaps in supplying the global community as well as needle-phobia which factors in vaccine hesitancy.

Jeremy Skillington, PhD, CEO of Poolbeg Pharma said: "We are grateful for the support of the Irish Government in awarding this funding and delighted to be working with our consortium of high-quality partners in University College Dublin, Trinity College Dublin and AnaBio. The funding will support the progression of this exciting oral vaccine platform that has the potential to improve the ways vaccines are manufactured, distributed and administered for the future. Poolbeg continues to target non-dilutive funding opportunities and we are delighted that this DTIF award is our first success."

Prof Siobhán McClean, Associate Professor at University College Dublin ("UCD") said: "I am pleased to work with the other members of this consortium to bring the antigens my team have identified and developed, closer to the clinic so that together, we can protect people from infectious diseases."

Prof Ed Lavelle, Professor of Immunology at Trinity College Dublin ("TCD") said: "The pharmaceutical industry has long aspired to develop subunit oral vaccines and I believe we have assembled a consortium of experts and ground-breaking technologies that are uniquely placed to make them a reality."

Dr Sinéad Bleiel, Founder & Chief Scientific Officer of AnaBio Technologies said: "Having demonstrated the potential of our encapsulation technology to deliver drug products safely and effectively to the gut, we are excited to collaborate with the EncOVac team of world class researchers, led by Poolbeg and supported by the Irish Government as part of the world's renewed fight against infectious diseases."

Prof Luke O'Neill, Non-Executive Director, Scientific Advisory Board and Project Advisory Board Chair said: "Oral vaccines are currently only available to treat a small number of pathogens and a more comprehensive approach to vaccine development is needed to design new, safe, and effective oral vaccines. Such a system would revolutionise our approach to protecting people from infectious diseases, unleashing their full potential."

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About EncOVac

Leveraging the pioneering work of Assoc. Professor Siobhán McClean in University College Dublin ("UCD"), the Consortium will use vaccine candidates identified in her lab as the basis for an oral vaccine that is generated through a highly specialized encapsulation process developed by Dr. Sinéad Bleiel of Anabio Technologies. Working with Ed Lavelle, vaccine adjuvant expert and a mucosal immunologist in Trinity College Dublin ("TCD"), the consortium will develop a vaccine candidate through pre-clinical testing to a Phase I ready state. Poolbeg has previously announced an exclusive license with Anabio for the use of their technology in vaccine delivery and has successfully in-licensed one vaccine candidate from UCD and continues to evaluate five other potential vaccine candidates developed by Associate Professor Siobhán McClean and her team.

About Oral Vaccines

By delivering vaccines to the gut, this approach can trigger 'mucosal immunity' that results in a protective response in the areas of the body where a pathogen would be inhaled or ingested such as the nose and digestive tracts. In comparison to intramuscular injections which generate systemic immunity, this approach prevents infections from taking hold in the body by counteracting them at the point of entry. This has the effect of both reducing transmission and preventing serious disease. Oral vaccines also offer an efficient method of administration and significantly reduce challenges for distribution, addressing the gaps in supplying the global community as well as needle-phobia which factors in vaccine hesitancy.

A recent World Health Organisation Report ("WHO") estimated that the global market value for vaccines was approximately $33b in 2019, before the substantial investment arising from the pandemic. The development of an oral vaccine platform that could replace some injectable vaccines would serve to improve vaccination rates, address critical inequalities in distribution and help to create a healthier world.

About the Disruptive Technologies Innovation Fund

The Disruptive Technologies Innovation Fund (DTIF) is a €500 million fund established under the National Development Plan (NDP) in 2018. The Department of Enterprise, Trade and Employment manages the DTIF with administrative support from Enterprise Ireland. The purpose of the Fund is to drive collaboration between Ireland's world-class research base and industry as well as facilitating enterprises to compete directly for funding in support of the development and adoption of these technologies. The aim is to support investment in the development and deployment of disruptive technologies and applications on a commercial basis.

About Poolbeg Pharma

Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a unique capital light clinical model which aims to develop multiple products faster and more cost effectively than the conventional biotech model. The Company, headquartered in London, is led by a team with a track record of creation and delivery of shareholder value and aspires to become a "one-stop shop" for pharma and biotech seeking mid-stage products to license or acquire.

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.

With its initial assets from hVIVO plc (formerly named 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 (POLB 001) which has commenced its LPS human challenge trial with initial results expected by year end 2022; 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 an oral vaccine delivery platform and is progressing two artificial intelligence (AI) programmes to accelerate the power of its human challenge model data and biobank, with results from the first programme expected by year end 2022.

Poolbeg's role in the project will be to prepare the vaccine candidate for clinical approval, including the preparation of pre-clinical toxicology work and the preparation of a regulatory dossiers for submission to the relevant authorities prior to the initiation of clinical trials. In addition to these activities, as the consortium-lead, Poolbeg will be responsible for project management, intellectual property protection and the coordination of publicity

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.

As part of the project, Anabio will be responsible for the encapsulation of the vaccine antigen and adjuvant combination. This will protect vaccine antigens from the degradative environment of the digestive tract and deliver vaccine constituents via a triggered release of microcapsule dissolution at a specific pH, which is characteristic to the location of the intestine where antigen uptake is targeted.

For further information, visit www.anabio.ie or email [email protected].

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.

To further expand the diseases the oral vaccine platform can target, the team in UCD will characterise and prioritise additional vaccines candidates using the proteomic platform technology previously developed by the McClean lab. Once a preferred candidate is identified, its efficacy following encapsulation will be assessed in an animal challenge model.

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.

The selection of an adjuvant that can help to stimulate robust mucosal immune responses for oral delivery will be a key task for the Lavelle lab during the course of the project. In the later stages of the project, the Lavelle lab will be responsible for the generation of data required for the filing of regulatory dossiers to proceed with clinical trials. 

For further information, visit www.tcd.ie