Poolbeg Pharma (POLB) , a clinical-stage biopharma company focused on infectious diseases, noted further data confirming the potential of its flagship POLB 001 anti-inflammatory candidate as a treatment for Cytokine Release Syndrome (CRS) associated with cancer immunotherapies. CRS is an often encountered side effect of CAR T-cell cancer therapies that causes potentially life-threatening hyperinflammation. CRS is also associated with severe influenza.
Poolbeg reported positive study results where POLB 001 demonstrated efficacy in reducing cancer immunotherapy-induced CRS in an in vivo animal model. CRS symptoms significantly improved following administration of POLB 001 with reductions seen in all serum proinflammatory cytokines tested.
The results, together with data from the recent LPS human challenge trial, support Poolbeg's expansion of the Phase 2-ready POLB 001 to treat and prevent cancer immunotherapy-induced CRS. The data also strengthens and facilitates the expansion of patent applications for POLB 001.
Poolbeg also shared the opinion of an independent advisory board comprised of international KOLs, healthcare payers, and clinical trial experts, that endorsed POLB 001's target product profile and its potential as an oral treatment for cancer immunotherapy-induced CRS.
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More positive data validating POLB 001's potential in addressing CRS in oncology. 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, adding to overall costs.
Current CRS treatments require intravenous infusion, which is difficult to deliver out of hospital. Due to the CRS risk, administration of cancer immunotherapies, such as bispecific antibodies, is currently restricted to specialist cancer centres, which limits their uptake. As an oral therapy to prevent or treat CRS, POLB 001 has the potential to enable broader use of cancer immunotherapies in an outpatient setting.
Therefore, the market opportunity for POLB 001 is substantial, estimated at over US$1 billion in Multiple Myeloma, High Grade Lymphoma, and Acute Lymphoblastic Leukaemia alone. The field of cancer immunotherapies is rapidly growing and expected to reach US$100bn by 2030. CRS is a significant obstacle to the delivery of potentially lifesaving therapies, explaining the strong interest in POLB 001 from pharma companies seeking an effective and orally administrable solution to CRS.
Today's results and earlier positive data from the POLB 001 LPS challenge trial highlight that oral treatment of POLB 001 holds substantial promise in tackling CRS. Delivering an effective oral drug for CRS will be a significant value inflection point for Poolbeg.
POLB shares gained 4% on the news.
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