Poolbeg Doses Eight Patients in POLB 001 TOPICAL Trial Targeting Immunotherapy-Induced CRS
核心洞察
Poolbeg Pharma (搜索) has dosed eight of approximately 30 planned participants in the TOPICAL trial of POLB 001, with the first patient treated in July 2026.
The trial tests POLB 001 as a preventative therapy for cytokine release syndrome (搜索) in relapsed/refractory multiple myeloma (搜索) patients receiving the bispecific antibody (搜索) teclistamab.
An interim review of the six-patient safety cohort recommended the trial continue as planned with no protocol changes, and additional UK sites may be activated.
Poolbeg Pharma (搜索) has dosed eight participants in its TOPICAL clinical trial of POLB 001, out of a planned total of approximately 30, the company reported on 28 September 2026. The first patient was dosed in July 2026, following a six-patient safety cohort. Recruitment is continuing across leading UK clinical sites, and further clinical sites have expressed interest in joining the study, which could support site expansion in the coming months.
Trial Design and Interim Safety Review
The TOPICAL trial is evaluating POLB 001 as a potential preventative therapy for cancer immunotherapy-induced cytokine release syndrome (搜索) (CRS) in patients with relapsed or refractory multiple myeloma who are receiving the approved bispecific antibody (搜索) teclistamab. Teclistamab, developed by Johnson & Johnson, links immune cells directly to cancer cells, and such bispecific antibodies can trigger CRS, an overreaction of the immune system that floods the body with inflammatory proteins.
On 24 September 2026, Poolbeg announced that the trial would proceed as planned following a positive review of data from the interim safety cohort. The review recommended that the trial continue with no changes required to the study protocol. The company described completion of the review as an important milestone for the TOPICAL trial.
Jeremy Skillington, PhD, chief executive officer of Poolbeg Pharma (搜索), said the interim cohort data represent a significant milestone for the trial. "The positive recommendation to continue the study as planned provides further confidence as we advance the POLB 001 programme," he said. "We are building momentum across the study, with recruitment continuing at leading UK clinical sites, further patients expected to be enrolled and additional sites activated."
In the 28 September recruitment update, Skillington added: "With eight participants dosed since mid-July and continued patient and investigator interest in the study, the trial continues to advance positively."
Rationale for CRS Prevention
Poolbeg states that POLB 001 has the potential to expand administration of cancer immunotherapies from centralised specialist cancer centres into community hospitals by making the treatments safer through prevention of CRS, a life-threatening side effect. The company says this could increase the number of patients able to receive these treatments.
Bispecific antibodies are becoming increasingly important in the treatment of cancer, and Poolbeg states that an effective CRS preventative therapy could represent an important advance for patients, clinicians and healthcare systems.
Funding and Partnering
Poolbeg raised GBP 3.5 million in July to fund the TOPICAL trial through to completion, alongside a separate study of an oral weight-loss drug. The company said it is in talks with potential partners about the POLB 001 programme and looks forward to generating further clinical data and sharing more detail with prospective partners.
Beyond POLB 001, Poolbeg is advancing development of a patient-friendly therapy for obesity with an oral encapsulated GLP-1 (搜索). The company describes itself as a clinical-stage biopharmaceutical company with a core focus on transforming the cancer immunotherapy field and is focused on partnering its programmes targeting large markets and addressing critical unmet medical needs.