Poolbeg Pharma PLC (AIM:POLB), a clinical-stage biopharmaceutical company focused on cancer immunotherapy, has dosed the first patient in its POLB 001 TOPICAL clinical trial.
The AIM-listed company is testing POLB 001 as a preventative treatment for cytokine release syndrome, a potentially serious immune reaction, in patients with relapsed or refractory multiple myeloma.
Those patients are receiving teclistamab, an approved bispecific antibody supplied free of charge by Johnson & Johnson (NYSE:JNJ).
University College London Hospital has been activated as a second trial site, with patient recruitment already underway.
Poolbeg said further clinical sites were expected to open imminently, supporting continued patient recruitment.
The company reported strong interest from the haematology community, including unsolicited enquiries from investigators keen to take part in the study.
Interim data remains on track for late summer 2026, which Poolbeg described as a significant value inflexion point for the programme.
The company is also advancing partnering discussions with several potential partners and expects that engagement to accelerate as additional clinical data becomes available.
A recent successful pre-investigational new drug (pre-IND) meeting with the US Food and Drug Administration has clarified the American regulatory pathway.
Poolbeg said independent US payer research validated the commercial opportunity for POLB 001, supporting premium pricing assumptions and reinforcing peak sales potential of several billion dollars.
Those findings strengthen the drug's appeal to potential commercial partners, the company added.
Poolbeg expects a steady flow of operational and clinical milestones in the coming months as recruitment progresses and interim data is generated.
Jeremy Skillington, chief executive, said the first dosing was an important milestone in evaluating POLB 001 as a therapy to prevent cytokine release syndrome linked to cancer immunotherapies.
He said bispecific antibodies such as teclistamab were rapidly improving outcomes for cancer patients and were increasingly used earlier in treatment, making effective management of the syndrome a priority.
Skillington added that clinical execution, regulatory progress and upcoming data created a compelling period of value creation for the company.
Dr Paul Sherrington, chief executive of Accelerating Clinical Trials, said many novel therapies had recently been approved for blood cancer patients and it was now vital to make them more widely available.
He said the trial's outcome could have a significant impact for patients.
