Active Biotech

“We are very happy with the response to our protocol amendments, and we expect to report interim results from the study in 2026 and study results towards the end of 2027,” said Active Biotech CEO Helén Tuvesson.

Lucia Masarova, M.D., associate professor of Leukemia at The University of Texas MD Anderson Cancer Center is the study’s principal investigator.

A protocol amendment was submitted to the US Food and Drug Administration (FDA) and the MD Anderson Institutional Review Board. The amendment aims to increase the flexibility in the dosing regimen of tasquinimod and broaden the patient population in the combination cohort of the study. The protocol amendment has now been approved, and the study will resume recruitment. The first patient was recruited in 2025.

The clinical study consists of two cohorts: tasquinimod as monotherapy in JAK2 inhibitor refractory or intolerant patients and tasquinimod in combination with a JAK2 inhibitor in patients with a suboptimal response to a JAK inhibitor alone. In the approved protocol amendment, the dosing schedule of tasquinimod closely reflects the schedule used in the previous phase III prostate cancer studies.

Furthermore, the amendment allows the combination of tasquinimod with either the JAK2 inhibitor ruxolitinib or the newly approved JAK2/ACVR1 inhibitor momelotinib.

For more information regarding the clinical study, see www.clinicaltrials.gov NCT06327100.