Poolbeg Pharma (POLB) reported interim results for the six months to 30 June 2026, highlighting continued progress with its lead POLB 001 programme, where eight patients have now been dosed in the TOPICAL trial and the study is continuing as planned following a positive safety review.
The clinical-stage biopharmaceutical company said no changes to the study protocol were required following the review of the initial six-patient safety cohort. Recruitment is continuing across specialist UK cancer centres, with further patients expected to enrol and additional sites showing interest in participating.
The TOPICAL trial is evaluating POLB 001 in ~30 relapsed or refractory multiple myeloma patients receiving Johnson & Johnson’s approved bispecific antibody teclistamab. POLB 001 is being developed as a potential preventative treatment for cancer immunotherapy-induced cytokine release syndrome (CRS).
Poolbeg also highlighted positive feedback from a pre-Investigational New Drug meeting with the US FDA, which provided greater clarity on the US development pathway and alignment on the proposed primary endpoint for a future Phase 3 trial.
Meanwhile, independent US payer research covering payers representing ~75 million lives indicated willingness to pay at commercially meaningful price points, supporting what Poolbeg described as multi-billion-dollar US peak sales potential for POLB 001.
The company has also expanded its patent estate, with patents in its cancer immunotherapy-induced CRS family granted in Australia, Canada and Europe, alongside a Notice of Allowance in Israel.
Poolbeg ended June with £4.8 million in cash. A £3.5 million fundraise completed in July is expected to fund both the POLB 001 TOPICAL trial and its oral glucagon-like peptide-1 (GLP-1) proof-of-concept trial through to completion, extending its cash runway into the second quarter of 2028.
The oral GLP-1 study is expected to begin in the second half of 2026.
Poolbeg Pharma’s Chief Executive Officer Jeremy Skillington said: “The first half of 2026 saw POLB 001 progress from TOPICAL trial preparation into execution, and we have built on that momentum since the period end. Eight patients have now been dosed in the TOPICAL trial and, following a positive review of data from the interim safety cohort, the study will continue as planned.
“POLB 001 has the potential to be the first approved preventative therapy for cancer immunotherapy-induced CRS. Positive FDA pre-IND feedback, a growing patent estate and independent US payer research all support its partnering potential.
“With both clinical programmes funded through to completion, we believe Poolbeg is well positioned for its next phase of value creation.”
View from Vox
Poolbeg’s interim results underline steady clinical and regulatory progress around POLB 001, while the July fundraise provides funding for both key programmes through to completion. Continued TOPICAL recruitment and the planned oral GLP-1 study provide further potential catalysts.