Poolbeg Pharma Plc

Poolbeg announces strategic expansion of POLB 001 into oncology

Complements strong initial data from LPS challenge trial and is in line with stated objective at IPO to expand POLB 001 to additional indications

Key Highlights

·      Newly filed patent application to protect use of POLB 001 for new oncology indication

·    Scientific findings indicate POLB 001 has the potential to dampen the pro-inflammatory cytokine release syndrome affecting patients receiving CAR T cell therapies

·      Patent application covers a method of use of all p38 inhibitors during CAR T cell therapy

·      Progressing towards trial initiation in CAR T cell patients in 2024

16 January 2023 - Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, 'Poolbeg' or the 'Company'), a leading infectious disease focused biopharmaceutical company, announces the strategic expansion of POLB 001 into oncology. While investigating the role of cytokine release syndrome ("CRS") in severe influenza, Poolbeg discovered data specific to the overt immune response in CAR T cell patients that suggest POLB 001 as a potential treatment option for this severe complication. The Company has submitted a patent application for the use of POLB 001 in addressing the impact of CRS in CAR T cell patients.

CAR T cell therapies are a form of immunotherapy for cancer that have produced remarkable results across a range of haematological malignancies, including cases of complete and durable responses in patients with advanced leukaemia and lymphoma who failed on previous therapies.  A significant number of patients suffer treatment related side effects, including CRS which in severe form can be life threatening. Cell therapies may induce these effects in up to 95% of patients¹. Poolbeg has identified POLB 001 as a potentially valuable companion therapy to be used in conjunction with existing CAR T cell therapies to address this significant unmet need. POLB 001's mode of action, reducing hyperinflammation which is associated with CRS, has the potential to significantly reduce the serious adverse effects experienced by many CAR T cell patients.

The filed patent application is expected to provide class protection for use of p38 inhibitors in CAR T cell treatment and opens up a significant new market opportunity for POLB 001 in addition to severe influenza.

A long-term strategic objective for Poolbeg has been and continues to be to evaluate POLB 001's potential in additional indications to fully unlock the potential value of the molecule and strengthen Poolbeg's position with a view to potential partnering and out-licensing. The Company is performing oncology clinical trial enabling activities to progress towards trial initiation in CAR T cell patients in 2024. Further oncology-related data, regulatory feedback and non-clinical development updates are expected in 2023.

Prof Brendan Buckley, Scientific Advisory Board member at Poolbeg Pharma, said: "Hyperinflammation as a driver of disease severity in influenza is also fundamental to CRS, which can severely complicate CAR T cell therapy of patients with blood cancers. By reducing runaway inflammation associated with CRS, POLB 001 has the potential to significantly reduce the serious adverse effects that many CAR T cell patients suffer. With 18-19 million cases of cancer diagnosed globally each year, the use of cell therapies is predicted to expand significantly over the coming years with the CAR T cell market expected to grow to an estimated $6 billion by 2031. With oncology clinical trial enabling activities for POLB 001 underway, we look forward to updating the market as to the progress of this exciting programme."

Virtual Company presentation

Jeremy Skillington, PhD, Chief Executive Officer, and Professor Brendan Buckley, Scientific Advisory Board member, will provide a live presentation via the Investor Meet Company platform on Monday 16 January 2023 at 5:30pm. Click here to register.

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.

1. CARVYKTI package insert, FDA, 2022

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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 (POB 001) which offers significant opportunity across multiple disease areas. The initial data analysis from its LPS human challenge trial indicates a marked reduction in both systemic and localised inflammatory response in an LPS human challenge trial (full data read-out expected in Q2 2023). Its other product candidates include 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.