Treatment potential for immunotherapy-induced CRS

Cytokine release syndrome

Poolbeg Pharma, a biopharmaceutical company focused on the development and commercialisation of medicines targeting diseases with a high unmet medical need, has announced promising in vivo results for POLB 001 in addressing cancer immunotherapy-induced cytokine release syndrome (CRS).  

POLB 001 demonstrated efficacy in reducing cancer immunotherapy-induced CRS in an in vivo animal model with CRS symptoms significantly improved following administration of POLB 001. Reductions were seen in all serum proinflammatory cytokines tested. 

The results, together with the data from the recent LPS human challenge trial, further support the strategic expansion of the Phase II 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 in cancer immunotherapy-induced CRS.  

Market opportunity estimated at over US$1 billion 

Largely due to the CRS risk (which can be life threatening), administration of cancer immunotherapies, such as bispecific antibodies, is currently restricted to specialist cancer centres which limits uptake of these therapies.  

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. The company believes that POLB 001 represents a significant market opportunity estimated at >US$1 billion in multiple myeloma, high grade lymphoma and acute lymphoblastic leukaemia alone.  

Cancer immunotherapies are being widely developed across a broader range of haematological malignancies, solid tumours and immune inflammatory diseases, which represents an even greater market opportunity.  

In the US, the American Cancer Society estimates that there will be 24.6 million cases of cancer by 20301,2. Cancer immunotherapies, such as bispecific antibodies and CAR-T cell therapy, are rapidly moving into earlier lines of treatment in many tumour types, with these markets anticipated to grow to US$100bn+ (~35% CAGR) by 20303. 

Independent Advisory Board shows support 

Poolbeg convened an Independent Advisory Board with international key opinion leaders, healthcare payers and clinical trial experts, which endorsed the attractiveness of POLB 001’s Target Product Profile (TPP) and its potential as an oral therapy to address the significant unmet medical need of cancer immunotherapy-induced CRS. POLB 001 has been shown to reduce hyperinflammation without complete ablation of an effective immune response, which makes it potentially a very attractive therapy for this disease area. 

Professor Gareth Morgan, NYU Langone, United States said: “Bispecific antibodies will only be delivered in specialist cancer centres until there is a way to make them safer. POLB 001 could make treatment safe enough to extend bispecifics to a much wider patient population”.  

Dr Martin Kaiser, Reader/Associate Professor in Molecular Haematology at The Institute of Cancer Research and Haematology Consultant at The Royal Marsden Hospital said: “Patients undergoing cancer immunotherapy treatment that suffer with CRS can be critically ill which, alongside a weakened immune system, can further increase their risk of infection. Preventing CRS in the first instance would have a significant impact on patient health and wellbeing, as well as reducing the burden on the healthcare system. Current CRS treatments require intravenous infusion, which is difficult to deliver out of hospital, and some can only be used off label in combination with bispecific antibodies. If there was a therapy that was orally delivered, a whole lot of infrastructure requirement falls away.” 

David Allmond, Chief Business Officer of Poolbeg Pharma, commented: “POLB 001 has the potential to revolutionise the impact of cancer immunotherapies by enabling safer and broader use in an outpatient setting, reducing healthcare resource utilisation and making these next-generation cancer treatments more widely available to the patients that need them. The pharmaceutical sector is seeking an effective solution for CRS and, as an oral therapy, we believe there is a significant opportunity for POLB 001 to meet this critical unmet medical need and have a positive impact on global health.” 


  1. The American Cancer Society (ACS)   
  2. The International Agency for Research on Cancer (IARC) 
  3. CAR T Cell Therapy Market Analysis 2023-2030; Bispecific Antibodies Market Size, Share & Trends Analysis Report, Grand View Research 

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