POLB 001

POLB 001 is an orally administered small molecule inhibitor of p38 mitogen-activated protein kinase (p38 MAPK), developed primarily for the prevention and treatment of cytokine release syndrome (CRS) associated with cancer immunotherapies such as bispecific antibodies and CAR T cell therapies. It is also being investigated for severe influenza infections due to its broad-spectrum anti-inflammatory properties. The drug acts by selectively inhibiting p38 MAPK signaling pathways, leading to significant reductions in key pro-inflammatory cytokines including TNF-α, IL-6, and IL-8 without ablating overall immune function. This mechanism interrupts the positive feedback loop of inflammatory mediators responsible for hyperinflammation or "cytokine storm," which can cause organ damage in diseases like CRS and severe influenza. Originally discovered by Uriach and further developed by Poolbeg Pharma along with other partners, POLB 001 has demonstrated safety in phase I trials and is advancing toward phase II studies in oncology indications[1][2][3][5][6].