Poolbeg Pharma plc

Poolbeg completes in-licence of Melioidosis vaccine candidate

Targeting an infectious disease with a high mortality rate and growing incidence driven by climate change

21 September 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 further to the Option Agreement announced in December 2021, Poolbeg has signed an exclusive Licence Agreement with University College Dublin (UCD) through NovaUCD, the University's knowledge transfer office, for a late preclinical stage vaccine candidate for Melioidosis, a disease for which there is no current approved vaccine available.

The vaccine candidate, which is being developed by Poolbeg as POLB 003, was invented following many years of research by Associate Professor Siobhán McClean, UCD School of Biomolecular and Biomedical Science, and was a recipient of a Wellcome Trust Award to aid its development.

Associate Professor McClean completed some of the original research to identify the antigens associated with the Melioidosis vaccine candidate at TU Dublin.

Melioidosis, also known as Whitmore's disease, is caused by the bacterium Burkholderia pseudomallei, Poolbeg identified the disease as an infectious disease of interest because of its rising incidence around the world due to climate change and its resistance to antibiotic treatment. As a US Centres for Disease Control and Prevention (CDC) designated biothreat, there is an increasing global need to develop effective vaccines and antibiotics to prevent and treat this disease.

As part of the Company's Option Agreement with UCD, Poolbeg continues to evaluate five other potential vaccine candidates being developed by Associate Professor McClean and her team. This includes Escherichia coli (O157); a powerful toxin that can severely harm children and elderly and leave lasting kidney damage and Pseudomonas aeruginosa; a highly antibiotic resistant bacteria which is the leading cause of morbidity and mortality in cystic fibrosis. As well as Klebsiella pneumoniae which is a prevalent issue in US Defence and healthcare settings resulting in burdensome management of complications, Burkholderia cepacia complex; a significant cause of hospital-acquired infections with large impact on health budgets and Acinetobacter baumannii which poses a threat to immuno- compromised patients in care settings such as cystic fibrosis patients.

Jeremy Skillington, PhD, CEO of Poolbeg Pharma said: "Melioidosis presents a growing threat to global health as an infectious disease with no approved vaccine and a high mortality rate. POLB 003 is being developed in line with our capital light approach and represents a significant opportunity for Poolbeg. Combined with the Company's expertise in infectious diseases it provides the perfect combination to contribute to the global response to this unmet-medical need and potential to generate significant returns for our investors."

Siobhán McClean, PhD, Associate Professor, UCD and inventor of MelioVac, said: "This partnership with Poolbeg will enable the further development of this important vaccine candidate. We are pleased to be bringing our technology, and Poolbeg's vaccine development expertise and industry network together to fight this growing infectious disease."

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About Melioidosis

Caused by the bacterium Burkholderia pseudomallei, commonly found in the soil and surface groundwater of many tropical and subtropical regions, Melioidosis causes a diverse range of symptoms including pneumonia and severe sepsis with multiple organ abscesses. There are an estimated 165,000 cases of Melioidosis each year, of which as many as 89,000 (54%) are estimated to be fatal. It is widespread in South-East Asia, Northern Australia and India, but the warming climate is having a substantial impact on the spread of the disease to new areas such as Brazil and traditionally non-tropical areas. As a US Centres for Disease Control and Prevention (CDC) designated biothreat, there is an increasing global need to develop effective vaccines and antibiotics to prevent and treat this disease.

About POLB 003

Through an extensive characterisation of the protein structures present on the bacteria's surface, the team at University College Dublin identified a homologue of the common OmpW bacterial antigen specific to this strain, called BpOmpW. Preclinical studies using this antigen showed significant survival benefit when challenged with the Burkholderia pseudomallei, the bacteria which causes Melioidosis. Similarly, so-called correlates of protection, which provide an indication of the protection status of a subject, were much improved including increased IFN-γ production and an enhanced T-Cell response profile, both of which have a proven role in protection against Melioidosis.

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 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.

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

About University College Dublin

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 theme are; creating a sustainable global society, transforming through digital technology, building a healthy world, and empowering humanity.

For further information, visit www.ucd.ie