Driving forward R&D programmes while seeking partners
POLB 001 is a small molecule immunomodulator targeting Cytokine Release Syndrome (CRS) experience in severe influenza and other acute inflammatory conditions. The most recent data from the LPS challenge study earlier this year showed that it effectively reduces multiple inflammatory cytokines in a dose-dependent manner and has a good safety profile. Based on WHO data, Poolbeg estimates there may be 3-5mln severe influenza cases a year globally. The company has been granted patents in the US and Europe out to 2038.
The opposition hearing scheduled by the European Patent Office relating to a challenge to the company's European patent (Immunomodulator I), was withdrawn in September 2023. This has now favourably concluded this matter with the patent maintained as granted. Immunomodulators I and II cover the use of P38 MAP kinase inhibitors for treatment of severe influenza and hypercytokinaemia — the uncontrolled and excessive release of pro-inflammatory signaling molecules (cytokines) that causes severe adverse physiological effects.
The company has a worldwide license to IP covering POLB 001 for all uses, but is expanding this IP protection to cover the use of p38 MAP kinase inhibitor class including for uses in oncology. In particular, it could be used to mitigate CRS, a common side effect to some oncology treatments, particularly CAR T cell therapy where it is seen in up to 95% of treatments. The most severe cases are life-threatening and can require intensive care support.
Poolbeg recently noted that as a result of its discussions with prospective partners, it is actively exploring a potential new indication for POLB 001 in oncology beyond CAR T. This could open up a further market for POLB 001. Development towards a clinical trial to advance POLB 001 in oncology is ongoing. Company partnering discussions about this molecule are ongoing.
POLB 001 status
Exhibit 1 - Cytokine Release Syndrome mechanism
Source: Poolbeg Investor Presentation
AI-assisted development
Poolbeg has collaborated with CytoReason and OneThree Biotech to utilise the companies' AI technologies to identify novel drug targets and treatments for influenza and Respiratory Syncytial Virus (RSV), respectively.
Lab-based validation is ongoing and management expects outputs for the RSV programme later this year, with the commencement of the influenza programme in 2024. The AI-led approach to drug discovery could enable faster and lower cost identification of drug targets, reducing risk and increasing likelihood of success.
Oral delivery platform
Poolbeg's oral delivery platform aims to target markets for vaccine delivery and the treatment of metabolic diseases using its licensed and validated encapsulation technology. These could be important markets for generating early revenue.
The EncOVac consortium, led by Poolbeg, was awarded €2.3mln in non-dilutive grant funding (which does not contribute to year-end cash figure) from the Irish government and has moved into the encapsulation validation phase. Management expects this to be completed in H2 2023. This technology platform covers multiple infectious diseases and could be an important commercial opportunity for the company.
The company's GLP-1 agonist for the treatment of metabolic diseases such as diabetes and obesity is progressing towards a proof-of-technology exploratory study to show that it can be delivered orally in humans. The trial is due to commence in H1 2024.
Exhibit 2 - Poolbeg product pipeline
Source: Poolbeg investor presentation