Poolbeg Pharma has dosed the first patient in a clinical trial evaluating POLB 001 to prevent cytokine release syndrome in multiple myeloma patients receiving immunotherapy.

Poolbeg Pharma has dosed the first patient in its TOPICAL clinical trial evaluating POLB 001 as a potential preventative treatment for cytokine release syndrome (CRS) in patients with relapsed or refractory multiple myeloma receiving bispecific antibody therapy.

The study is investigating POLB 001 alongside teclistamab, an approved bispecific antibody therapy supplied by Johnson & Johnson at no cost to the company. CRS is a potentially serious inflammatory response that can occur following certain cancer immunotherapies and remains one of the key challenges associated with these treatments.

The first patient dosing marks the start of clinical evaluation for the programme, with interim data expected later this summer.

Poolbeg also announced that University College London Hospital has been activated as a second trial site, with patient recruitment now underway. The company expects additional clinical sites to begin enrolling patients in the coming weeks to support recruitment.

Bispecific antibodies such as teclistamab have transformed treatment options for patients with multiple myeloma but can trigger cytokine release syndrome, which ranges from mild flu-like symptoms to severe, life-threatening complications. Developing therapies that prevent CRS could enable wider use of these cancer treatments while improving patient safety.

Jeremy Skillington, 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.”

POLB 001 is being developed as a preventative therapy designed to reduce the inflammatory response associated with cancer immunotherapies without affecting their anti-cancer activity. The company believes this approach could help improve tolerability and expand access to immunotherapy treatments.

Poolbeg said interest in the study has been strong, with investigators expressing interest in participating as recruitment continues across additional sites.

The company also confirmed that interim clinical data remain on track for late summer 2026. Earlier this year, Poolbeg announced a successful FDA pre-IND meeting to discuss the US regulatory pathway for POLB 001.

Jeremy Skillington added: “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, chief executive officer 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.”

If successful, POLB 001 could offer a new approach to managing one of the most significant adverse events associated with modern cancer immunotherapies, supporting safer treatment for patients receiving bispecific antibodies and other immune-based therapies.