POLB 001 / Poolbeg Pharma - LARVOL DELTA

Polb 001, an Oral Broad-Spectrum Anti-Inflammatory with the Potential to Prevent Cytokine Release Syndrome (CRS) (ASH 2023) - P1 | "Current treatments are dominated by reactive administration of tocilizumab, steroids or anakinra. POLB 001 is undergoing preclinical evaluation in humanized mouse models (NSG-(KbDb)null (IA)null) of T-cell engaging bispecific antibodies, CD19 CAR-T cell therapy for hematological malignancies and for CD28 induced cytokine storm. A Phase 2 trial of POLB 001 in Multiple Myeloma patients receiving T-cell engaging antibodies is planned."

Cytokine release syndrome • IO biomarker • Hematological Malignancies • Immunology • Infectious Disease • Inflammation • Influenza • Multiple Myeloma • Oncology • Respiratory Diseases • Systemic Inflammatory Response Syndrome • CRP • CXCL8 • IL10 • IL1B • IL6 • POLG2 • TNFA

Polb 001, an Oral p38 MAPK Inhibitor, Reduces Cytokine Release Syndrome (CRS) in a Mouse Model of Immunotherapy-Induced CRS (ASH 2024) - "Treatment of CRS includes anti-pyretic or anti-cytokine therapies such as tocilizumab (anti-IL-6R), anakinra (anti-IL-1RA), and corticosteroids...The positive control group was immediately dosed intraperitoneally with adalimumab (5 mg/kg)...POLB 001 significantly reduced peak serum levels of IL-4, IL-6, IL-8 and MIP1-α; all other cytokines tested, including IFN-γ, TNF, IL-10 and IL-2, showed trends of reduced peak serum levels. In combination with a previous successful trial in healthy human volunteers, the results of this animal study further support development of POLB 001 in a Phase 2 clinical study as a prophylactic for the prevention of immunotherapy-induced CRS."

Cytokine release syndrome • Preclinical • Hematological Malignancies • Inflammation • Oncology • CXCL8 • IFNG • IL10 • IL1R1 • IL2 • IL4 • POLG2

Poolbeg wins US backing for treatment aimed at serious cancer therapy side effects (Proactiveinvestors) - "Poolbeg Pharma PLC...has secured a key regulatory boost from the US authorities for a drug it is developing to prevent a dangerous complication linked to advanced cancer treatments. The London-listed biotech group said on Tuesday that the Food and Drug Administration had granted Orphan Drug Designation to POLB 001, an experimental treatment designed to protect patients from a condition known as cytokine release syndrome (CRS)....POLB 001 is a tablet designed to block a protein called p38 MAP kinase, which plays a key role in triggering the inflammatory response linked to CRS. The company is preparing to start a mid-stage clinical trial in the second half of this year, with early results expected in the first half of 2026 and headline data by the end of that year."

New trial • Orphan drug • Oncology

Effects of p38 MAPK Inhibitor POLB 001 on in Vivo LPS Challenge Responses (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Poolbeg Pharma plc | Recruiting ➔ Completed | Trial completion date: Apr 2023 ➔ Dec 2022

Trial completion • Trial completion date • Infectious Disease • Influenza • Respiratory Diseases • CXCL8 • IL10 • IL6 • POLG2