Poolbeg Pharma 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.