Active Biotech has announced that its clinical Phase I/II study, HOVON 172 MF, evaluating tasquinimod in patients with myelofibrosis who are refractory to or intolerant of JAK2 inhibition, has received full approval from the European Medicines Agency (EMA) and the Institutional Ethics Committees. This approval paves the way for the trial to commence enrollment in the near future.
Trial Design and Objectives
The single-arm, multicenter, open-label study will investigate the safety and efficacy of tasquinimod when administered as a monotherapy. The patient population will consist of individuals with myelofibrosis who have previously been treated with a JAK2 inhibitor or are ineligible for such treatment. The primary efficacy endpoint is defined as the proportion of patients achieving at least a 35% reduction in spleen volume following six 4-week cycles of tasquinimod treatment.
Study Locations and Sponsorship
The clinical trial will be conducted within the Stichting Haemato-Oncologie Volwassenen Netherland (HOVON) network of study centers, spanning sites in the Netherlands and Germany. HOVON will serve as the legal sponsor of the study. Financial backing for the trial is primarily provided by Oncode Institute, under a global patent license agreement with Active Biotech for tasquinimod in myelofibrosis, established in February 2022.
Tasquinimod's Mechanism and Prior Research
Tasquinimod is an orally available small molecule immunomodulator designed to block tumor-supporting pathways within the bone marrow microenvironment. It is under development as a potential immunomodulatory treatment for hematological malignancies. Prior studies have explored tasquinimod as an anti-cancer agent in solid tumors, including a Phase III randomized trial in metastatic prostate cancer, establishing a well-characterized tolerability profile. Preclinical models of multiple myeloma have demonstrated tasquinimod's therapeutic potential, both as a single agent and in combination with standard therapies. Furthermore, tasquinimod has shown promise in ameliorating disease development in preclinical myelofibrosis models. A Phase Ib/IIa clinical study is currently underway to evaluate tasquinimod in relapsed and refractory multiple myeloma.
Executive Commentary
Dr. Erik Vahtola, CMO of Active Biotech, stated, "With all the approvals in place, we expect the study to start enrolment shortly. The study is supported by strong preclinical data indicating disease-modifying potential of tasquinimod. I look forward to the enrollment of the first patient and I am excited to follow the study progress."
