Poolbeg Pharma Regulatory News (POLB)

Poolbeg Pharma plc

POLB 001 patent portfolio strengthened through granting of US patent

Key highlights

· Patent granted for use of certain p38 MAP kinase inhibitors for the treatment of hypercytokinaemia

· Allows for use in combination with an antiviral agent

· Patent enhances the robust IP portfolio protecting Poolbeg's growing pipeline

8 March 2023 - Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, 'Poolbeg' or the 'Company'),  a leading infectious disease focused biopharmaceutical company, announces that further to its announcement on 4 October 2022, it has been granted a patent by the US Patent and Trademark Office (USPTO) for methods of treating hypercytokinaemia using POLB 001, a small molecule immunomodulator being developed to address the unmet medical need arising from severe influenza and other acute inflammatory conditions.

The USPTO granted a patent for the use of POLB 001 and related p38 MAP kinase (mitogen-activated protein kinase) inhibitors for the treatment of hypercytokinaemia (or "cytokine storm"), including hypercytokinaemia that occurs due to viral infection such as an influenza virus, cancer or an autoimmune response, through the modulation of the immune response (reducing the body's hyperinflammatory response).

Poolbeg has a worldwide license for POLB 001 for all uses in humans and is developing a strong IP portfolio with US patent protection in place covering the use of a wide range of p38 MAP kinase (mitogen-activated protein kinase) inhibitors for the treatment of symptoms of severe influenza and hypercytokinaemia and a European patent for the class of p38 MAP kinase inhibitors for use in the treatment of severe influenza.

In January 2022, the Company filed a patent application to seek class protection for the novel use of p38 inhibitors in CAR T cell treatment. This opens up a significant new market opportunity for POLB 001 beyond severe influenza. Poolbeg continues to explore opportunities to expand its IP around this asset to cover new disease areas which could enhance the value of the asset.

The Company continues to work with its patent advisors to broaden and expand its patent families.

Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said:

"We are expanding our IP portfolio across the globe, allowing us to continue advancing and protecting our programmes for the treatment or prevention of severe influenza and hypercytokinaemia. Enhanced IP protection of our assets across key markets, such as the US, increases the overall value and attractiveness of these products to potential partners. This is particularly important in the light of the recent favourable results from our POLB 001 LPS human challenge trial announced 2 March 2023."

About POLB 001

POLB 001 is a small molecule immunomodulator for the treatment of symptoms of severe influenza, and hypercytokinaemia which may occur due to exposure to a pathogen or be triggered by cancer or an autoimmune response. Poolbeg continues to discover new indications for POLB 001 in other acute inflammatory conditions. POLB 001 selectively inhibits overwhelming inflammation that may be triggered by viral infections, such as severe influenza, while leaving the necessary immune functions intact to fight the infection. This contrasts with other immunomodulatory approaches, such as steroids, which affect both beneficial and damaging immune responses. Due to its mode of action it is strain agnostic and unaffected by seasonal variants which is a significant advantage over treatments available on the market. In addition, as a shelf stable oral drug it is an ideal stock piling candidate for both seasonal and pandemic outbreaks. Therefore, POLB 001 has the potential to be a transformational treatment for patients and to become a leading severe influenza treatment.

Cytokines, originally intended to optimise immunity, when overexpressed can sweep throughout the body re-programming white blood cells causing tissue damage, shutting down circulation and other essential organs leading to death and in certain circumstances cytokine storm or cytokine release syndrome (CRS). Such excessive cytokine responses can be seen in diseases as diverse as severe influenza and in response to chimeric antigen receptor T cell therapy (CAR T cell) treatment of cancers. Poolbeg continues to evaluate POLB 001's potential in additional indications to fully unlock the potential value of the molecule.

p38 MAP kinase (p38 MAPK) is a master regulator of immunity, ubiquitously expressed in all white blood cells where it is poised to unleash inflammation. Poolbeg's clinical approach, inhibiting p38 MAP kinase hypothesised that it's a prime suspect in driving the cytokine storm and its consequences in patients whose immune responses do not resolve normally, without intervention. This has now been demonstrated as a concept in a human clinical model of infectious disease and endotoxin mediated inflammation administering LPS as the endotoxin to healthy volunteers. LPS is a bacterial product that mimics infection and is used to capture the hallmarks of both local and systemic inflammation typical of a cytokine storm in humans, but in a safe, controlled and quantifiable manner - it's one step removed from the infected critical care patient. Treatment with POLB 001 resulted in a highly significant reduction in p38 MAP kinase driven cytokines and exhibited a marked reduction in multiple markers of systemic and local inflammation compared with placebo. Read more here.

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About Poolbeg Pharma

Poolbeg Pharma specialises in the development of innovative medicines to address the unmet need in prevalent and emerging infectious diseases. Poolbeg has a disciplined portfolio approach to mitigate risk, accelerate drug development and enhance investor returns. The Company simultaneously advances multiple programmes in cost-effective clinical trials, rapidly generating early human safety and efficacy data to enable early partnering / out-licensing, with the funds generated reinvested in the pipeline. Poolbeg also uses AI to interrogate human challenge trial data sets to quickly identify new targets and drugs, and in-license near or in the clinic medicines, leading to faster development and greater commercial appeal.

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 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 and other acute inflammatory conditions (POLB 001) which produces a highly significant reduction in p38 MAP kinase driven cytokines in a clinical setting; 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 two Oral Delivery Programmes and is progressing two Artificial Intelligence (AI) Programmes to add promising new assets to its pipeline.

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