Poolbeg Pharma plc

Further Data Confirms POLB 001's Potential in Cancer Immunotherapy-Induced Cytokine Release Syndrome (CRS)

Market opportunity estimated to be greater than US$1 billion

Key highlights

-      Efficacy demonstrated in reducing cancer immunotherapy-induced CRS in an in vivo model

-      Data strengthens and facilitates the expansion of patent applications for POLB 001 in cancer immunotherapy-induced CRS

-      Independent Advisory Board supportive of POLB 001's potential to both prevent and treat cancer immunotherapy-induced CRS

-      An Investor Meet Company presentation scheduled at 6pm on 17 January 2024 with Poolbeg management and Key Opinion Leader, Dr Martin Kaiser

17 January 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, today announces promising in vivo results for POLB 001 in addressing cancer immunotherapy-induced CRS.

Positive study results

POLB 001 demonstrated efficacy in reducing cancer immunotherapy-induced CRS in an in vivo animal model with CRS symptoms significantly improved following administration of POLB 001. Reductions were seen in all serum proinflammatory cytokines tested.

The results, together with the data from the recent LPS human challenge trial, further support the Company's strategic expansion of the Phase II ready POLB 001 to treat and prevent cancer immunotherapy-induced CRS. The data also strengthens and facilitates the expansion of patent applications for POLB 001 in cancer immunotherapy-induced CRS.

Market opportunity estimated at over US$1 billion

Largely due to the CRS risk (which can be life threatening), administration of cancer immunotherapies, such as bispecific antibodies, is currently restricted to specialist cancer centres which limits uptake of these effective therapies. As an oral therapy to prevent or treat CRS, POLB 001 has the potential to enable broader use of cancer immunotherapies in an outpatient setting. The Company believes that POLB 001 represents a significant market opportunity estimated at > US$1 billion in Multiple Myeloma, High Grade Lymphoma and Acute Lymphoblastic Leukaemia alone. Cancer immunotherapies are being widely developed across a broader range of haematological malignancies, solid tumours and immune inflammatory diseases, which represents an even greater market opportunity.

In the U.S., the American Cancer Society estimates that there will be 24.6 million cases of cancer by 2030^1,2. Cancer immunotherapies, such as bispecific antibodies and CAR T cell therapy, are rapidly moving into earlier lines of treatment in many tumour types, with these markets anticipated to grow to US$100bn+ (~35% CAGR) by 2030³.

Independent Advisory Board Supportive of POLB 001's Potential 

Poolbeg convened an Independent Advisory Board with international Key Opinion Leaders, healthcare payers and clinical trial experts, which endorsed the attractiveness of POLB 001's Target Product Profile (TPP) and its potential as an oral therapy to address the significant unmet medical need of cancer immunotherapy-induced CRS. POLB 001 has been shown to reduce hyperinflammation without complete ablation of an effective immune response, which makes it potentially a very attractive therapy for this disease area.

Prof. Gareth Morgan, NYU Langone, United States said "Bispecific antibodies will only be delivered in specialist cancer centres until there is a way to make them safer. POLB 001 could make treatment safe enough to extend bispecifics to a much wider patient population".

Dr Martin Kaiser, Reader/Associate Professor in Molecular Haematology at The Institute of Cancer Research and Haematology Consultant at The Royal Marsden Hospital said, "Patients undergoing cancer immunotherapy treatment that suffer with CRS can be critically ill which, alongside a weakened immune system, can further increase their risk of infection. Preventing CRS in the first instance would have a significant impact on patient health and wellbeing, as well as reducing the burden on the healthcare system. Current CRS treatments require intravenous infusion, which is difficult to deliver out of hospital, and some can only be used off label in combination with bispecific antibodies. If there was a therapy that was orally delivered, a whole lot of infrastructure requirement falls away."

David Allmond, Chief Business Officer of Poolbeg Pharma, commented: "POLB 001 has the potential to revolutionise the impact of cancer immunotherapies by enabling safer and broader use in an outpatient setting, reducing healthcare resource utilisation and making these next generation cancer treatments more widely available to the patients that need them. The pharmaceutical sector is seeking an effective solution for CRS and, as an oral therapy, we believe there is a significant opportunity for POLB 001 to meet this critical unmet medical need and have a positive impact on global health."

Investor presentation

Poolbeg's management team along with Martin Kaiser, Reader/Associate Professor in Molecular Haematology at The Institute of Cancer Research and Haematology Consultant at The Royal Marsden Hospital, will provide a live presentation via the Investor Meet Company platform on Wednesday 17 January 2024 at 6pm GMT.

The presentation is open to analysts and investors, those who already follow Poolbeg on the Investor Meet Company platform will automatically be invited. Investors can sign up to Investor Meet for free and add Poolbeg Pharma plc to their company dashboard via: https://www.investormeetcompany.com/poolbeg-pharma-plc/register-investor

References

1.     The American Cancer Society (ACS)  

2.     The International Agency for Research on Cancer (IARC)

3.     CAR T Cell Therapy Market Analysis 2023-2030; Bispecific Antibodies Market Size, Share & Trends Analysis Report, Grand View Research

Enquiries

About Poolbeg Pharma

Poolbeg Pharma plc is committed to the development and commercialisation of innovative medicines targeting diseases with a high unmet medical need. 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 CRS induced by cancer immunotherapies, 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. 

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.

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