Poolbeg Pharma plc

Notice of Allowance for Significant POLB 001 Patent in United States

Notice of Allowance for Immunomodulator II further strengthens robust intellectual property portfolio

20 March 2024 - Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, 'Poolbeg' or the 'Company'), a biopharmaceutical company focussed on the development and commercialisation of innovative medicines targeting diseases with a high unmet medical need, announces that it has received a Notice of Allowance from the US Patent Office in relation to its Immunomodulator II patent application. A Notice of Allowance is a precursor to the expected formal grant of a patent in due course.

POLB 001, a potent and selective Phase II-ready p38 MAP kinase inhibitor (mitogen-activated protein kinase), has strong potential across multiple disease areas. The claims which the US Patent Office have deemed acceptable to grant cover a class of drugs (including POLB 001) for treating hypercytokinaemia (cytokine storm) and for preventing hypercytokinaemia in a patient after an immune response has been triggered. This encompasses cytokine storm induced in any disease indication.

Poolbeg is actively building a comprehensive IP portfolio, with patents in place covering p38 MAP kinase inhibitors for the treatment of severe influenza; and covering POLB 001 for the treatment of hypercytokinaemia. Further patent applications have been filed and have complementary coverage as the Company continues to expand its patent portfolio covering POLB 001 and the wider class of p38 MAP kinase inhibitors, particularly in respect of cancer immunotherapies, thereby enhancing the value and attractiveness of POLB 001 to potential Pharma partners.

Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma, commented: "This Notice of Allowance is significant for Poolbeg, further strengthening our robust intellectual property for the Company's exciting POLB 001 therapy and enhancing its value for potential partners. POLB 001 has the potential to make breakthrough cancer immunotherapies more accessible to the patients that need them by enabling safer and broader use of these cancer treatments in an outpatient setting. I am excited by the potential of POLB 001 to positively impact global health, it has a compelling data package and there is strong unmet need for an effective therapy for cancer immunotherapy-induced Cytokine Release Syndrome with the market potential in this setting alone exceeding US$10 billion."

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About Poolbeg Pharma

Poolbeg Pharma plc is committed to the development and commercialisation of innovative medicines targeting diseases with a high unmet medical need, with a growing emphasis on rare and orphan diseases. Its model focusses upon developing its exciting clinical assets and commercialising approved and marketed drugs to fund the development of its robust pipeline of innovative products, thereby driving significant value creation.

Poolbeg is led by an experienced leadership team with a history of delivering significant shareholder value. The team has been strengthened by the appointment of three former members of the Amryt Pharma plc leadership team, with the intention of repeating Amryt's success and generating near term revenues.

Poolbeg's clinical programmes target large addressable markets including cancer immunotherapy-induced CRS, infectious disease, and metabolic conditions such as obesity with the development of an oral GLP-1R agonist. It uses a cost-effective development philosophy to generate high quality human data to support partnering and further development. Its AI-led infectious disease programmes analyse unique data from human challenge trials to identify clinically relevant drug targets and treatments, leading to faster development and greater commercial appeal. 

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

Forward-Looking Statements

This announcement may contain forward-looking statements and the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Poolbeg's present and future business strategies and the environment in which Poolbeg expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond Poolbeg's ability to control or estimate precisely, such as future market conditions, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Poolbeg's ability to obtain financing, changes in the political, social and regulatory framework in which Poolbeg operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information.