Poolbeg Pharma's POLB 001 shows strong pre-clinical results in treating CRS, Phase 2 trials next
() , a clinical-stage biopharma company focused on infectious diseases, noted highlights from its poster presentation at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place in San Diego from December 7-19, 2024. Poolbeg presented data related to its flagship POLB 001 anti-inflammatory candidate.
Poolbeg's presentation focused on POLB 001's potential to treat hyperinflammation associated with cytokine release syndrome (CRS) that affects patients receiving CAR T-cell cancer therapies. CRS is an often encountered side effect of such immunotherapies that causes potentially life-threatening hyperinflammation. CRS is also associated with severe influenza.
Specifically, Poolbeg delved into positive results obtained from a pre-clinical POLB 001 in vivo study, a mouse model of immunotherapy-induced CRS. 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.
Poolbeg announced that POLB 001 effectively reduced CRS and demonstrated superior cytokine inhibition compared to Adalimumab. Mice were treated twice daily with either placebo or POLB 001 at low, medium, or high doses for 5 days, and all doses significantly reduced clinically observed CRS scores. Other immunological and malignancy-related endpoints were also monitored, with no harmful effects of POLB 001 observed.
Mark Sumeray, MD, Consultant Clinical Advisor for Poolbeg, commenting: "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."
View from Vox
Poolbeg has presented excellent data related to its flagship POLB 001 anti-inflammatory candidate, validating its potential in addressing cytokine release syndrome (CRS). The positive results further reinforce the use case for POLB 001 in the prevention and treatment of cancer immunotherapy-induced CRS. Next, investors can look forward to Phase 2 clinical studies.
CRS is a well-recognised toxicity that occurs frequently following certain cancer treatments such as T-cell engaging antibodies and CAR T cell therapies. In addition to patient mortality and morbidity risk, the high frequency of CRS associated with these treatments represents a barrier to outpatient delivery. The need for in-patient management of CRS adds to the overall healthcare costs of delivering these treatments and contributes to restricting their availability.
An effective drug for CRS therefore has the potential to make cancer immunotherapies more tolerable and widely accessible, and enable patients to fully benefit from their treatment. The positive results from the POLB 001 in vivo study further highlight the candidate's potential. Delivering an effective oral drug for CRS will be a significant value inflection point for Poolbeg.
The field of cancer immunotherapies is rapidly growing and expected to reach US$100bn by 2030. POLB 001's potential to treat cancer immunotherapy-induced CRS alone has a 3rd party-estimated market potential of US$10bn. CRS is a significant obstacle to the delivery of lifesaving therapies, explaining the strong interest in POLB 001 from pharma companies seeking an effective and orally administrable solution to CRS. Poolbeg's second participation at ASH should benefit those discussions.
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