Irish clinical-stage biopharmaceutical company Poolbeg Pharma has received Clinical Trial Authorisation from the UK Medicines and Healthcare products Regulatory Agency for its TOPICAL trial, investigating lead candidate POLB 001 as a preventative therapy for cancer immunotherapy-induced Cytokine Release Syndrome, according to FirstWord Pharma.

With all regulatory clearances now in place and site initiation visits scheduled, the trial remains on track to deliver interim data this summer. The study spans six sites across the UK, including NHS Lothian in Edinburgh, the Royal Stoke University Hospital, The Christie, The Royal Marsden, University College London Hospitals, and University Hospitals Birmingham.

The TOPICAL trial will investigate POLB 001 in approximately 30 relapsed or refractory multiple myeloma patients receiving the approved bispecific antibody teclistamab, supplied by Johnson & Johnson at no cost to Poolbeg.

Independent US payer research conducted by Acumetis Global, engaging payers covering approximately 75 million lives across commercial insurance, Medicare, and Medicaid, confirmed multi-billion-dollar peak sales potential for POLB 001 in the United States.

Jeremy Skillington, chief executive of Poolbeg Pharma, said: "We believe POLB 001 has the potential to transform the cancer immunotherapy field through the prevention of CRS, improving patient quality of life and expanding the number of patients that can receive these life-saving cancer immunotherapies."

Chris Grimes Crompton, Partner at Acumetis Global, said the research validated both the scale of unmet need and payer appetite for an effective preventative approach, with willingness to pay at commercially meaningful price points driven by potential reductions in hospitalisation costs.

CRS currently occurs in the majority of CAR T and bispecific antibody treatments, with no established diagnostic method available to predict its likelihood or severity in individual patients.

Read the full report for comprehensive details on the TOPICAL trial and POLB 001 commercial opportunity.