Irish biotech's cancer drug trial cleared to continue

Pictured Jeremy Skillington, Chief Executive Officer at Poolbeg Pharma. Picture Jason Clarke

Dublin-based Poolbeg Pharma says its lead cancer immunotherapy drug trial will go ahead unchanged after an interim review of safety data.

The AIM-listed company said a review of the trial's interim safety cohort recommended that the TOPICAL trial continue with no changes to the study protocol. Recruitment is continuing at UK sites, including The Christie in Manchester, The Royal Marsden and University College London Hospitals.

The trial is testing POLB 001, an oral drug designed to prevent cytokine release syndrome (CRS). CRS is a potentially dangerous immune overreaction triggered by bispecific antibodies and CAR-T therapies, two of the most promising classes of cancer immunotherapy. CRS affects between 60% and 80% of patients on these treatments, is currently managed with injectable tocilizumab and corticosteroids after it develops, and has no approved preventative therapy.

Because of that risk, the treatments are generally given in specialist cancer centres, where patients can be closely monitored. Poolbeg argues that preventing CRS could allow these treatments to be given in community hospitals, not only in specialist cancer centres. As such, POLB 001 could increase the number of patients that can receive these life-saving treatments, thereby increasing the market opportunity.

"If ultimately successful, the significance could be substantial. Reducing the risk and severity of CRS could potentially allow these transformative cancer treatments to be administered more widely and, over time, closer to patients’ homes rather than exclusively in major specialist cancer centres," the company said.

Poolbeg gave the example of cancer patients from Donegal, Kerry or Galway potentially having to travel to a major specialist centre for treatment and monitoring. The longer-term possibility is that more of this treatment could be delivered closer to their local community and potentially, in some circumstances, eventually in the home.

"The data from the interim cohort represent a significant milestone for the TOPICAL trial," said chief executive Jeremy Skillington. He added that the company looks forward to "sharing more detail with prospective partners as we continue discussions around the POLB 001 opportunity."

Poolbeg, whose board includes immunologist Professor Luke O'Neill, plans to license POLB 001 to a larger drugmaker once it reaches a clinical inflection point. Johnson & Johnson is supplying teclistamab, the cancer drug used in the trial, at no cost. In May the FDA broadly aligned with Poolbeg's development plan, including the primary endpoint for a future Phase III trial.

Poolbeg is also advancing the development of a patient-friendly therapy for obesity with an oral encapsulated GLP-1, offering a differentiated approach within one of the world’s largest markets