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Poolbeg Pharma #POLB – Artificial intelligence programme yields multiple novel RSV drug targets
8 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 it has made a significant breakthrough in its Artificial Intelligence (‘AI’) Programme with partner OneThree Biotech, Inc. through the discovery of novel drug targets for the treatment of Respiratory Syncytial Virus (‘RSV’).
Following the completion of the build and optimisation of a tailored AI model in June 2022, the OneThree team, using its clinically validated AI platform, have identified novel drug targets using Poolbeg’s unique RSV human challenge trial data. The identification of these novel drug targets now allows the final stage of the programme to commence which will involve the identification of small molecule inhibitors to effectively treat RSV infections. The team are particularly excited as these include a range of targets for which there are known drugs with existing Phase I safety and tolerability data. Prioritisation of compounds with existing Phase I data aligns with Poolbeg’s capital light model as these compounds will have extensive nonclinical and clinical data allowing smooth transition to early human efficacy trials.
The final stage of the research plan will utilise OneThree’s proprietary ATLANTIS AI platform to identify the drugs that are most likely to be efficacious against the identified disease targets with clean safety profiles in RSV patients. Selection of drugs is traditionally a long and extensive process, however, by using an existing AI model this process can be completed in weeks. Results of this stage are expected before year end 2022.
Traditional drug design is focused on identifying a molecule that can bind with a specific target within a cell. Poolbeg’s approach, utilising OneThree Biotech’s advanced AI models, allows for the complex disease signature underlying each drug target to be considered during drug selection. This allows the complex outputs of this stage, which represent novel biological insights, to be advanced to the final stage which will match drugs to prioritised targets. By working from disease signatures like this, OneThree Biotech can utilise the full strength of its AI technology to pinpoint the drug molecules that can precisely and effectively reverse disease signatures and produce meaningful clinical benefits.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said:
“This is the first time that AI has been used to identify disease targets in RSV and I am delighted to have reached this significant milestone in the programme in such a short period of time. Having identified these novel disease targets, we can now commence the final stage of the programme to identify effective drug candidates to treat RSV. In keeping with our capital-light model, this AI enabled in silico R&D approach has significantly accelerated the discovery process by having the right partners and the right expertise to unleash the potential of our unique human challenge trial data. We greatly look forward to seeing the outputs of this programme later this year.”
Neel S. Madhukar, PhD, CEO of OneThree Biotech said:
“This analysis is pioneering in RSV research, and we are pleased to have identified disease targets from which effective drug candidates can be explored. We are fortunate to have access to Poolbeg’s unique human challenge trial data because it was collected in a controlled and powered quarantine which increases the overall strength and predictive power you can get from it. Additionally, thanks to the combination of Poolbeg’s data and our ATLANTIS platform, we were able to reach this point in our project in only eight months – significantly faster than a traditional drug discovery project – and we’re excited to make meaningful progress in the treatment of infectious diseases, such as RSV.”
– Ends –
Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 (0) 207 183 1499 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, Charlie Beeson
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+44 (0) 207 220 0500 |
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Singer Capital Markets (Joint Broker) Phil Davies, Sam Butcher
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+44 (0) 207 496 3000 |
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
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Instinctif Partners Melanie Toyne Sewell, Rozi Morris, Tim Field
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+44 (0) 20 7457 2020 poolbeg@instinctif.com |
About RSV
RSV is a contagious virus that affects people’s respiratory tract with children and at-risk older adults being particularly vulnerable; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties. RSV is a significant public health threat affecting an estimated 50 million people annually, leading to 4 million global hospitalisations and an estimated 100,000 deaths in children under the age of 5 years. An estimated 45% of these cases and deaths occur in new-born infants under the age of 6 months. Studies have suggested that treatment for RSV in children under five alone costs governments globally €4.8bn every year.
About Poolbeg’s AI Programmes
Poolbeg Pharma has access to a unique private repository of clinical samples and associated data from human challenge trials via its relationship with Open Orphan plc, a resource which is anticipated to expand over the coming years. Human challenge trial data is unique in the depth of longitudinal virology, health, biomarker and symptom data collected during the course of disease. These datasets provide clinical insights into disease that guides Poolbeg Pharma’s product acquisitions and clinical development.
The Company is currently progressing two AI Programmes, the first in RSV in partnership with OneThree Biotech, and the second in influenza in partnership with CytoReason. Poolbeg believe that this is the first time that AI analysis has been undertaken on RSV and influenza human challenge trial data and samples to identify new drug targets and treatments. The unique nature of human challenge trials to produce disease progression data with high precision is revolutionising the insights into human disease.
Poolbeg’s asset POLB 001, which has commenced its LPS human challenge trial with initial trial data expected before year end, was identified using such disease progression data. However, by utilising AI, the Company aims to identify more targets quicker and more cost efficiently than previously possible without this technology.
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.
For more information, please go to www.poolbegpharma.com or follow us on Twitter and LinkedIn @PoolbegPharma.
About OneThree Biotech
OneThree Biotech is a private, clinically validated, biology-driven artificial intelligence (AI) company focused on using its proprietary ATLANTIS AI platform in combination with systems biology to understand the mechanisms that drive drug-target-disease relationships. This approach has been used not only to generate a pipeline of first-in-class programs, but also in partnerships with other biopharmaceutical companies. OneThree Biotech’s proven technology platform integrates chemical, biological, and clinical data with cutting-edge computational tools to answer complex questions surrounding disease biology and drug discovery. The company’s AI platform has shown success in identifying new targets for the treatment of various cancers and optimizing early-stage drug discovery and development by quickly and accurately generating new, testable insights and hypotheses. The OneThree platform has been validated across early-stage drug discovery through multiple partnerships, clinical trials, and more than 20 peer-reviewed publications. OneThree Biotech is based in New York City.
Twitter: @onethreebiotech
Poolbeg Pharma #POLB – POLB 001 US Patent update
4 October 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, provides an update on the strengthening of its intellectual property (IP) position around POLB 001, a small molecule immunomodulator for the treatment of severe influenza.
The US Patent and Trademarks Office, after reviewing a patent application that is directed to the use of POLB 001 and its homologues for the treatment of hypercytokinemia (or “cytokine storm”), has indicated to the Company that the main claim is allowable. Poolbeg anticipates receiving a formal patent grant in due course and has filed a continuing application to seek protection for additional claims around this indication.
Poolbeg has a worldwide license for POLB 001 for all uses in humans and is developing a strong IP portfolio with patent protections in place covering the use of the class of p38 MAP kinase (mitogen-activated protein kinase) inhibitors for the treatment or prevention of severe influenza and hypercytokinaemia. The Company is exploring the opportunity to expand its IP around this asset to cover new disease areas which could enhance the value of the asset for partnering purposes.
US and European patents have already been granted with claims to the treatment of severe influenza, which is characterised by symptoms that persist or recur for more than two days without signs of resolution, with a p38 MAP kinase inhibitor inhibiting the release of pro-inflammatory mediators from endothelial cells and pro-inflammatory cytokines from immune cells. These granted patents offer protection until at least 2037.
Assessment of applications filed in other territories is ongoing.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma said:
“We are continuing to expand our global patent protection for our growing pipeline of infectious disease products. We are delighted to receive confirmation from the US Patent and Trademarks office that the main claim is allowable, and we look forward to updating the market when we receive the formal patent grant in due course. Enhanced IP protection of our assets across key markets, such as the US, increases the overall value of these products to potential partners. This is particularly important as we move closer to the completion of our POLB 001 LPS human challenge trial, with initial results expected by year end 2022.”
– Ends –
Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 (0) 20 7183 1499 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, James Thompson, Charlie Beeson, Sunila de Silva (ECM), Nigel Birks
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+44 (0) 20 7220 0500 |
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Singer Capital Markets (Joint Broker) Phil Davies, Sam Butcher
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+44 (0) 20 7496 3000 |
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
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Instinctif Partners Melanie Toyne Sewell, Rozi Morris, Tim Field
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+44 (0) 20 7457 2020
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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.
Alan Green covers Poolbeg Pharma #POLB & Sovereign Metals #SVML on this week’s Stockbox Research Talks
Alan Green covers Poolbeg Pharma #POLB & Sovereign Metals #SVML on this week’s Stockbox Research Talks
Poolbeg Pharma #POLB licence of Melioidosis vaccine candidate
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.”
– Ends –
Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 (0) 20 7183 1499 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, James Thompson, Charlie Beeson, Sunila de Silva (ECM), Nigel Birks
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+44 (0) 20 7220 0500 |
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Singer Capital Markets (Joint Broker) Phil Davies, Sam Butcher
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+44 (0) 20 7496 3000 |
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
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Instinctif Partners Melanie Toyne Sewell, Rozi Morris, Tim Field |
44 (0) 20 7457 2020 |
Notes to Editors
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
Poolbeg Pharma #POLB – Interim results for the six months to 30 June 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 its unaudited interim results for the six months to 30 June 2022.
Financial & Operational Highlights
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Well capitalised with a strong cash balance of £18.9m as at 30 June 2022 |
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Significant progress made on developing POLB 001, a treatment for severe influenza |
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LPS human challenge trial commenced in July 2022 with initial results expected by year end 2022 |
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Supply Agreement signed and GMP manufacturing completed |
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Key US patent granted in May 2022 |
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Continuing to explore further disease indications beyond severe influenza |
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Two AI programmes commenced to analyse Poolbeg’s unique human challenge trial data |
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Agreement signed with OneThree Biotech Inc. in February 2022 to identify new drug targets and treatments for Respiratory Syncytial Virus (RSV). The programme is progressing well with the model build and optimisation completed in June 2022, with results expected by the end of 2022 |
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In March 2022 an agreement was signed with CytoReason Ltd. to identify novel drug targets for influenza. Data analysis is ongoing, and results are expected in Q2 2023 |
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Licensed first-in-class broad spectrum RNA-based immunotherapy (POLB 002) for respiratory virus infections from the University of Warwick in January 2022 |
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Key European and US patents granted in April and May 2022 respectively |
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Diligence completed on POLB 003, an intramuscular vaccine candidate to prevent Melioidosis from University College Dublin. Definitive license agreement being finalised following exclusive option agreement (signed in December 2021) |
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Licensed AnaBio Technologies’ micro- and nanoencapsulation technology to develop oral vaccines in January 2022 |
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Investor presentation
Jeremy Skillington, PhD, Chief Executive Officer, will provide a live presentation via the Investor Meet Company platform on 6 September 2022 at 6:00pm.
The presentation is open to all existing and potential shareholders. Investors can sign up to Investor Meet Company for free and add to meet Poolbeg Pharma plc here. The presentation and recording will be available on the Company’s website after the event here.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma said: “I am pleased with the progress that the team has made to advance and expand our portfolio of products and platforms, and we intend to build on and accelerate this rate of progress in the remainder of 2022 and beyond.
“Poolbeg is entering a very exciting phase in its development with a number of near-term value inflection points expected before year end. This includes the initial results from our LPS human challenge trial for our severe influenza treatment, POLB 001, after which we will seek to out-licence to pharma and biotech companies, generating revenues from upfront payment and downstream milestones and royalties. In addition, the outputs from our RSV and influenza Artificial Intelligence Programmes are expected by the end of 2022 and in Q2 2023 respectively.
“We have strong financial resources available to progress our products and platforms and also to capitalise on new opportunities as we identify them which, in addition to our upcoming value inflection points, gives me confidence that we can generate strong returns for shareholders.”
– Ends –
Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 (0) 20 7183 1499 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, James Thompson, Charlie Beeson, Richard Chambers, Sunila de Silva (ECM), Nigel Birks
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+44 (0) 20 7220 0500 |
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Singer Capital Markets (Joint Broker) Phil Davies, Sam Butcher
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+44 (0) 20 7496 3000
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
|
Instinctif Partners Melanie Toyne Sewell, Rozi Morris, Tim Field
|
+44 (0) 20 7457 2020
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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.
Link here to view the full results and financial statements
A landmark year for Poolbeg Pharma #POLB – Alan Green talks to CEO Jeremy Skillington
A landmark year for Poolbeg Pharma #POLB – Alan Green talks to CEO Jeremy Skillington, who takes us through what has been a very eventful year since the IPO. At 01:58 we discuss the flagship asset POLB 001, which reached a major milestone last week as it commenced a human challenge trial. At 05:00 Jeremy provides an overview of two collaborations in Artificial Intelligence and how Poolbeg will use these pioneering approaches to identify new treatments for infectious diseases. At 08:57 Jeremy outlines what investors should expect for the remainder of 2022.
UK Investor Magazine Podcast – Covering Royal Mail #RMG Poolbeg Pharma #POLB & GreenX Metals #GRX
Alan Green joins the Podcast for an in-depth discussion around the current market conditions and a selection of UK equities.
We break down the current market dynamics and question whether we have seen a bottom in markets as investor sentiment improves.
Royal Mail has changed their name after a torrid period of trading and a rather challenging outlook. Pressures from unions and falling volumes create a potentially toxic cocktail for the company and this has been reflected in the share price.
Poolbeg Pharma have announced a bug step forward in their flagship project in the commencement of a trial for POLB 001, a strain agnostic, small molecule immunomodulator.
GreenX Metals is creating a portfolio of metals with applications in clean technology. Their shares popped higher today as they begin a field program at their copper project in Greenland.
Poolbeg Pharma #POLB – Major milestone reached as POLB 001 human challenge clinical trial ready to commence
20 July 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, has received ethics and competent authority approval to commence its Lipopolysaccharide (LPS) human challenge clinical trial for POLB 001, a strain agnostic, small molecule immunomodulator which aims to address the unmet medical need for a treatment for severe influenza.
Key Highlights:
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Clinical trial activities will formally commence on 22 July 2022 |
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The trial will assess the efficacy of POLB 001 in dampening the robust immune response to LPS which acts as a surrogate for the hyperinflammatory response associated with severe influenza and other diseases |
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Start of the trial demonstrates significant delivery on commitment at IPO |
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Initial results expected in Q4 2022 at which point the Company intends to rapidly monetise by out-licensing / partnering with pharma and biotech companies for further development of POLB 001 |
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Trial success would also pave the way for potential applications beyond severe influenza |
Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said: “This is a major milestone for Poolbeg as we are ready to commence the LPS human challenge trial of POLB 001, our severe influenza treatment. Significant preparatory work has been completed in order to reach this stage with the completion of GMP* manufacturing, formulation, trial protocol design amongst other vital regulatory requirements. We look forward to receiving the valuable, broad-ranging data and insights that this trial is expected to generate by the end of 2022. We stated at our IPO in July 2021 that we intended to bring POLB 001 into the clinic for this LPS trial in the summer of 2022 and are happy to have achieved this stated objective and demonstrate our ability to effectively execute on our strategy.
“The unmet need for new treatments for severe influenza presents a significant opportunity to improve outcomes for patients as well as to potentially rapidly monetise our lead asset. The unique mode of action of POLB 001 to reduce hyperinflammatory response in the body means that it is agnostic to the strain of virus and has the potential to expand to other disease indications and as such, could provide further opportunities to create significant value beyond severe influenza for the Company and our shareholders.”
*Good Manufacturing Practice
The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.
Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 (0) 207 183 1499 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, James Thompson, Charlie Beeson
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+44 (0) 207 220 0500 |
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Arden Partners PLC (Joint Broker) John Llewellyn-Lloyd, Louisa Waddell
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+44 (0) 207 614 5900 |
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
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Instinctif Partners Melanie Toyne Sewell, Rozi Morris, Tim Field
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+44 (0) 20 7457 2020 |
About Poolbeg Pharma
Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a 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 Big Pharma 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 will commence its LPS human challenge trial imminently, with results expected by year end 2022. A first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections. (POLB 002); and a vaccine for Melioidosis (POLB 003). The Company is also developing an oral vaccine delivery platform and is progressing two artificial intelligence (AI) drug discovery programmes to accelerate the power of its human challenge model data and biobank.
For more information, please go to www.poolbegpharma.com or follow us on Twitter and LinkedIn @PoolbegPharma
Further detail on the LPS trial, POLB 001 and the Influenza opportunity and beyond
Rigorous randomised, double-blind, placebo-controlled, multiple dose, LPS human challenge trial in 36 healthy volunteers to assess efficacy of POLB 001 in treating the dangerous effects of severe influenza. As part of the trial, researchers will stimulate the immune systems of healthy volunteers with LPS across three cohorts. LPS triggers a robust immune response and acts as a surrogate for the hyperinflammatory effects associated with severe influenza infection, as well as other diseases. Each cohort will receive escalating doses of POLB 001 to evaluate its effectiveness in suppressing the body’s harmful inflammatory response to both intradermal (a shallow injection) and intravenous (an injection in a vein) administered LPS.
The Principal Investigator is Dr. Matthijs Moerland and the trial will be conducted at the Centre for Human Drug Research in The Netherlands and has received all relevant regulatory and ethics approvals. POLB 001 has previously been proven to be safe and well tolerated in a successful Phase I clinical trial. The first results of this LPS human challenge trial are expected before the end of the year, and the Company expects to be in a position to rapidly monetise POLB 001 thereafter by partnering or out-licensing to Pharma for further development and commercialisation.
Influenza is a viral pathogen that infects approximately one-eighth of the world’s population each year, an estimated 1 billion people infected globally, attacking the respiratory system leading to between 5 and 10 million hospitalisations and as many as 500,000 influenza related deaths. Survivors of severe influenza can suffer organ damage, leading to chronic and life-changing injuries. Given POLB 001’s mode of action, it is strain agnostic meaning that it treats the body’s reaction to infection rather than targeting the virus directly and, as such, POLB 001 is unaffected by the seasonal variants of influenza that arise each year which is a significant advantage over treatments available on the market. Therefore, POLB 001 has the potential to be a transformational treatment for patients and to become a leading severe influenza treatment. POLB 001 has patent protection until 2038 and is a shelf-stable oral drug which makes it ideal as a stockpiling candidate for both seasonal outbreaks and pandemic preparedness.
POLB 001 also has potential therapeutic applications beyond severe influenza, due to its mode of action of reducing hyperinflammation (cytokine storm). This is when harmful inflammation occurs in different areas of the body, such as the heart and lungs, causing organ damage which is linked with many diseases. POLB 001 has the potential to block this by interrupting the positive feedback loop of inflammatory mediators. Poolbeg is currently investigating new potential uses and in due course hopes to expand its IP around this asset to cover new disease areas thereby increasing the value of the asset.
News Poolbeg Pharma AI model of respiratory syncytial virus starts analysis
Poolbeg featured in the @MorningstarInc following yesterdays announcement on the completion of build 7 optimisation of our #AI model for RSV #data, the first time AI used to model #RSV with complete longitudinal #disease data.
Link below to read in full:
https://www.morningstar.co.uk/uk/news/AN_1656323268845373200/poolbeg-pharma-ai-model-of-respiratory-syncytial-virus-starts-analysis.aspx
Poolbeg Pharma #POLB – Article
The @McKinsey’s #biotech #investment themes article highlights “insufficient number of high-quality data”a limitation to AI #drugdiscovery #POLB‘s #AI programmes have access the world’s largest data & #biobank of high-dimensional #disease progression data
The @McKinsey’s #biotech #investment themes article highlights “insufficient number of high-quality data”a limitation to AI #drugdiscovery#POLB's #AI programmes have access the world's largest data & #biobank of high-dimensional #disease progression datahttps://t.co/E5rwZlIqu1
— Poolbeg Pharma (@PoolbegPharma) June 14, 2022