First patient dosed in the POLB 001 tOPICAL clinical trial
Poolbeg Pharma, a clinical-stage biopharmaceutical company with a core focus on transforming the cancer immunotherapy field, today announces that the first patient has been dosed in the POLB 001 TOPICAL clinical trial.
The dosing of the first patient in the TOPICAL clinical trial marks the start of an active period of clinical execution for the POLB 001 programme. The trial is investigating POLB 001 as a potential preventative therapy for Cytokine Release Syndrome ("CRS") in patients with relapsed/refractory multiple myeloma receiving the approved bispecific antibody, teclistamab, which is being supplied by Johnson & Johnson at no cost to the Company.
University College London Hospital (UCLH) has now also been activated as a clinical trial site. Activation of additional trial sites is expected imminently, supporting continued patient recruitment.
The TOPICAL clinical trial has generated strong interest from the haematology community, including unsolicited enquiries from investigators interested in participating in the study, reflecting the enthusiasm for POLB 001 as a preventative therapy for CRS. Interim data remains on track for late summer 2026 and represents a significant value inflection point for the programme. In parallel, Poolbeg continues to advance partnering discussions with multiple companies, with engagement expected to accelerate as additional clinical data becomes available.
The recent successful FDA pre-IND meeting has helped clarify the US regulatory pathway and independent US payer research validates the significant commercial opportunity for POLB 001, supporting premium pricing assumptions and reinforcing the programme's multi-billion-dollar peak sales potential. These findings further strengthen POLB 001's attractiveness to potential commercial partners.
The Company expects a steady flow of operational and clinical milestones over the coming months as recruitment progresses, additional sites become active and interim data is generated. Poolbeg will update shareholders as these milestones are achieved and as partnering discussions continue to advance.
Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma, said:
The dosing of the first patient is an important milestone as we evaluate POLB 001 as a potential therapy to prevent CRS associated with cancer immunotherapies. Bispecific antibodies, such as teclistamab, are rapidly improving cancer patient outcomes and are increasingly being used earlier in disease treatment, making effective CRS management a priority for patients, clinicians and healthcare systems.
As recruitment progresses and additional clinical sites become active, we anticipate a steady stream of operational updates ahead of interim data later this summer. We also continue to make encouraging advances in discussions with potential partners and believe the combination of clinical execution, regulatory progress and upcoming data creates a compelling period of value creation for Poolbeg."
Dr Paul Sherrington, CEO of Accelerating Clinical Trials Ltd said:
In recent times, many novel therapies have been approved for blood cancer patients, and it is now vitally important that we make these more broadly available to the patients who need them. The outcome of this important trial may have a very significant impact for patients.
