Poolbeg Pharma plc (LON: POLB), a clinical-stage biopharmaceutical company focused on the development and commercialisation of innovative medicines targeting diseases with a high unmet medical need, has announced key insights from its poster presentation at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, San Diego, California.
The poster, which detailed POLB 001 as a promising preventative therapy for Cytokine Release Syndrome (CRS) associated with cancer immunotherapies, was presented by the Company’s Chief Executive Officer, Jeremy Skillington, PhD on Saturday 7 December.
The study was designed to evaluate the effect of POLB 001 on CRS compared to Adalimumab, an anti-TNF antibody which is a gold standard potent inhibitor of CRS in humanised tumour-bearing mouse models. Mice were treated twice daily with either placebo or POLB 001 at low, medium, or high doses for five days.
Key Highlights:
- POLB 001 effectively reduced CRS and demonstrated superior cytokine inhibition compared to Adalimumab
- In a model of anti-CD28 induced CRS, POLB 001 was shown to dose dependently reduce clinical CRS scores
- POLB 001 reduced peak serum levels of TNF, IL-4, IL-6, IL-8 and MIP-1α and the results were statistically significant
- All other cytokines tested, including IFN-γ, IL-8, IL-10 and IL-2, demonstrated trends of reduced peak serum levels
- Other immunological and malignancy-related endpoints were monitored with no harmful effects of POLB 001 observed
- Positive results reinforce the use case for POLB 001 in the prevention and treatment of cancer immunotherapy-induced CRS
Mark Sumeray, MD, Consultant Clinical Advisor for Poolbeg Pharma, commented: “Addressing cancer immunotherapy-induced CRS holds the potential to greatly impact the treatment of hematological malignancies – enhancing safety and reaching more patients. These data presented at ASH are promising, demonstrating statistically significant cytokine inhibition and a dose dependent reduction in clinical CRS. The results of this animal study support development of POLB 001 in a Phase 2 clinical study as a prophylactic for the prevention of immunotherapy-induced CRS. The previous successful LPS trial in healthy human volunteers also provides ratification.”
Poster Presentation Details:
Title: POLB 001, an Oral p38 MAPK Inhibitor, Reduces Cytokine Release Syndrome (CRS) in a Mouse Model of Immunotherapy-Induced CRS
Session Name: 703. Cellular Immunotherapies other than CAR-T Cells: Basic and Translational: Poster I
Session Date and Time: Saturday, 7 December 2024, 5:30 PM – 7:30 PM PST
Location: San Diego Convention Center, Halls G-H
Authors: Liam Tremble, PhD, MSc, BSc, Paula Maguire, PhD, Jiwon Yang, PhD, James G Keck, Laura Maher, MSc, Mark Graham, Martin F Kaiser, MD, FRCP, FRCPath, Emma Searle, MD, PhD and Mark Sumeray, MD
Abstract Number: 2061
