Poolbeg Pharma PLC (AIM:POLB) this week announced the activation of clinical trial sites for its POLB 001 programme, marking the start of patient enrolment in a study designed to prevent cytokine release syndrome (CRS) associated with cancer immunotherapies.
Speaking with Proactive, Principal Scientist Liam Tremble said the trial is now underway across several leading UK centres and is being supported by Accelerating Clinical Trials Limited (ACT), a specialist organisation embedded within the blood cancer treatment community.
The study is evaluating POLB 001 as a preventative treatment for CRS, a potentially serious adverse event commonly associated with CAR-T therapies and bispecific antibodies. The open-label, single-arm trial is expected to enrol 30 patients receiving teclistamab.
Tremble explained that CRS typically occurs during the first two weeks of treatment initiation, allowing investigators to assess outcomes relatively quickly after prophylactic administration of POLB 001. The company believes the programme addresses an important challenge facing the wider adoption of immunotherapies.
Here, we take a closer look at what was said when Liam Tremble joined the Proactive studio.
Proactive: Liam, you announced site activation for your POLB 001 trial this morning. Why is this an important development?
Liam Tremble: I'm delighted to say that the trial is underway and we're really excited. The trial is being conducted at a number of leading sites across the UK. These sites have large catchment areas and use of teclistamab is increasing significantly, which is positive for patients and supports recruitment. We are working with Accelerating Clinical Trials Limited (ACT), a specialist blood cancer organisation already embedded within the haematology community at these sites. Everything is set up well to deliver the study.
Proactive: For those unfamiliar, can you give us a quick overview of the trial and the potential impact POLB 001 could have for patients?
Liam Tremble: POLB 001 is a preventative treatment for cytokine release syndrome (CRS), an adverse effect associated with a growing number of immunotherapies including CAR-T cells and bispecific antibodies. The current study is an open-label, single-arm trial involving 30 patients.
CRS generally occurs within the first two weeks after patients begin treatment and receive step-up doses of bispecific antibodies. We will prophylactically dose POLB 001 and expect to assess results relatively quickly.
This is important because these therapies can be life-saving treatments for conditions such as multiple myeloma, but they are not available to all patients who could benefit from them. POLB 001 has the potential to make these treatments safer and more accessible.
Proactive: I also noticed a second announcement that POLB 001 clinical data will be featured in two posters at EHA. Tell us more.
Liam Tremble: We're excited to share data generated both internally and by the University of Manchester.
One poster relates to cytokine release syndrome and represents the closest model we have to the ongoing clinical study. Using in vitro and humanised mouse models, we tested POLB 001's ability to reduce key cytokines and CRS while ensuring it did not impair the tumour-killing activity of bispecific antibodies. The results were overwhelmingly positive.
A second poster from the University of Manchester explores a different potential application for POLB 001 in acute myeloid leukemia (AML). Treatment options for AML remain limited. Early-stage preclinical research suggests combining POLB 001 with azacitidine or other hypomethylating agents may improve outcomes in these models.
The university used an aged mouse model because AML typically affects older patients. The results are promising and we are pleased to share them.
Proactive: I hope you'll continue to keep us updated with your progress. Thank you for your time today.
