A London-based biotechnology company is preparing to begin a clinical trial across six NHS hospitals for a drug designed to prevent cytokine release syndrome (CRS), a potentially life-threatening complication associated with modern cancer immunotherapy treatments.
Poolbeg Pharma, headquartered in London, has announced that its experimental oral drug POLB 001 will be evaluated in patients receiving advanced blood cancer therapies. The company hopes the treatment will reduce the risk of CRS, a severe immune reaction that can occur when immunotherapy activates the body’s defence system too aggressively, leading to widespread inflammation, organ damage, and, in some cases, intensive care admission.
A Significant Challenge in Cancer Immunotherapy
Immunotherapy has transformed the treatment landscape for several blood cancers, including multiple myeloma and diffuse large B-cell lymphoma. Therapies such as CAR T-cell treatments and bispecific antibodies have delivered impressive results for patients who previously had limited options.
However, these treatments carry a substantial risk of cytokine release syndrome. CRS typically begins with symptoms such as fever, rapid heartbeat, low blood pressure, and severe inflammation. In serious cases, patients may require hospitalisation in specialist cancer centres where clinicians can monitor and manage complications immediately.
Current clinical practice often requires patients to remain in hospital for extended periods after receiving immunotherapy, even if they never develop CRS. This creates additional pressure on healthcare systems and limits access to treatment for patients living far from major cancer centres.
How POLB 001 Is Intended to Work
Poolbeg’s drug was originally developed for chronic inflammatory conditions before being repurposed for oncology. According to the company, POLB 001 works by blocking a specific cell-signalling pathway involved in excessive immune activation.
The upcoming trial will involve approximately 30 patients receiving Johnson & Johnson’s blood cancer therapy teclistamab, marketed as Tecvayli. Participants will begin taking POLB 001 at home before starting their cancer treatment, with the aim of moderating the immune response before CRS can develop.
The study is being led by researchers at the University of Manchester and The Christie NHS Foundation Trust, one of Europe’s leading cancer centres.
Potential Benefits for Patients and the NHS
One of the most significant potential advantages of a successful CRS-prevention therapy would be the ability to deliver immunotherapy more widely outside highly specialised centres.
Poolbeg argues that if the risk of CRS can be substantially reduced, patients could receive treatment closer to home in community hospitals rather than travelling to major cities for prolonged monitoring. This could improve access for people living in rural areas and reduce the logistical burden associated with advanced cancer care.
The company also believes the approach could generate considerable savings for health systems by reducing hospital stays, intensive monitoring requirements, and emergency interventions.
Growing Demand for Immunotherapy
The market for advanced blood cancer immunotherapies is expected to expand rapidly over the coming decade. Poolbeg estimates that by 2031 roughly half a million patients with multiple myeloma or diffuse large B-cell lymphoma in the United States and the five largest European markets could receive these therapies.
Because existing treatments often require lengthy hospital stays to manage CRS risk, a preventative drug could have a substantial impact on both patient experience and healthcare capacity.
The company estimates that the commercial opportunity for an effective CRS-prevention therapy could be significant, given the high cost and growing use of modern immunotherapies.
Interim Results Expected Later This Year
Poolbeg expects to receive interim data from the study by the end of the summer. The results will provide an early indication of whether POLB 001 can safely reduce the incidence and severity of cytokine release syndrome in patients receiving teclistamab.
Success in this trial would likely lead to larger studies involving additional cancer immunotherapies and broader patient populations.
Broader Development Pipeline
In addition to its oncology programme, Poolbeg is developing an oral GLP-1 weight-loss treatment in partnership with Irish microencapsulation company AnaBio Technologies. An early-stage study involving healthy volunteers with obesity is expected to begin later this year.
The company was spun out of clinical research organisation hVIVO in 2021 and is listed on London Stock Exchange’s AIM market.
Addressing NHS Capacity Pressures
Poolbeg’s leadership says the project aligns with broader efforts to reduce pressure on NHS services while improving access to innovative treatments.
With demand for cancer care continuing to rise and healthcare resources under strain, technologies that allow safe treatment outside specialist centres could become increasingly important.
Whether POLB 001 can deliver that outcome will depend on the results of the NHS trial, but the study represents an important step in addressing one of the most challenging side effects associated with modern cancer immunotherapy.