Lively Biotech has obtained optimistic suggestions from regulators on a protocol modification to its ongoing proof-of-concept scientific trial evaluating tasquinimod in sufferers with myelofibrosis, a uncommon and critical blood most cancers. Following approval of the modification by the U.S. Meals and Drug Administration (FDA) and The College of Texas MD Anderson Most cancers Heart Institutional Evaluation Board, the examine will resume affected person recruitment.
In keeping with Helén Tuvesson, CEO of Lively Biotech, “We’re very pleased with the response to our protocol amendments, and we anticipate to report interim outcomes from the examine in 2026 and examine outcomes in the direction of the top of 2027.”
The trial is led by principal investigator Dr. Lucia Masarova, affiliate professor within the Division of Leukemia at MD Anderson Most cancers Heart.
Tasquinimod Examine in Myelofibrosis Resumes With Expanded Choices
The amended trial is designed to supply larger flexibility in tasquinimod administration and to broaden eligibility within the mixture therapy group. The up to date dosing schedule extra intently mirrors the routine utilized in prior part 3 research of tasquinimod in metastatic prostate most cancers, the place its security profile was established.
Importantly, the modification permits tasquinimod to be mixed with both Jakafi (ruxolitinib), a generally used Janus kinase 2 (JAK2) inhibitor, or Ojjaara (momelotinib), a just lately accredited twin JAK2/ACVR1 inhibitor. This transformation expands choices for sufferers whose illness has not responded adequately to a JAK inhibitor alone.
The trial consists of two distinct cohorts. One cohort is evaluating tasquinimod as a single agent in sufferers who’re refractory to or illiberal of prior JAK2 inhibitor remedy. The second cohort is finding out tasquinimod together with a JAK inhibitor in sufferers who’ve skilled a suboptimal response to JAK inhibitor therapy. The primary affected person was enrolled in 2025.
By increasing the dosing flexibility and mixture methods, investigators intention to raised perceive how tasquinimod might match into the present therapy panorama for myelofibrosis, significantly for sufferers with restricted therapeutic choices.
Understanding Myelofibrosis and Present Remedy Limitations
Myelofibrosis is a uncommon myeloproliferative neoplasm characterised by irregular manufacturing of blood-forming cells within the bone marrow. Over time, wholesome bone marrow is changed with scar tissue, a course of often known as fibrosis. The annual incidence of myelofibrosis is roughly 1.5 instances per 100,000 individuals throughout the US, European Union, United Kingdom and Japan.
Sufferers often current with anemia and irregular white blood cell counts. Because the illness progresses, people might expertise splenomegaly, fatigue, evening sweats, fever and elevated susceptibility to infections. Myelofibrosis is related to lowered survival, and issues might embody bone marrow failure or transformation to acute leukemia.
Present therapy choices focus totally on symptom management. Bone marrow transplantation gives a possible treatment for choose eligible sufferers, though many people usually are not candidates attributable to age or comorbidities. JAK inhibitors, together with ruxolitinib and momelotinib, are generally used to cut back spleen measurement and alleviate signs. Erythropoietin might assist handle anemia. Nevertheless, no accredited therapies have been proven to reverse bone marrow fibrosis.
How Tasquinimod Works and What Researchers Hope to Be taught
Tasquinimod is an oral small molecule immunomodulator with a novel mechanism of motion. It targets tumor-supporting pathways throughout the bone marrow microenvironment, which play a job in sustaining irregular blood cell manufacturing and fibrosis. In preclinical fashions of myelofibrosis, tasquinimod has demonstrated reductions in myeloproliferation, splenomegaly, and bone marrow fibrosis. Exercise has been noticed each as monotherapy and together with accredited brokers.
Tasquinimod has additionally been studied extensively in stable tumors, together with a big part 2 to three improvement program in metastatic prostate most cancers. These prior trials have helped outline its security profile, offering a basis for ongoing improvement in hematologic malignancies.
The present proof-of-concept examine in Europe and the US seeks to judge security, tolerability, and early indicators of scientific exercise in sufferers with myelofibrosis. By together with people who’re refractory to JAK inhibitors and people with suboptimal responses, the trial addresses a inhabitants with vital unmet medical want.
Sufferers and caregivers looking for extra details about the examine can go to ClinicalTrials.gov and seek for identifier NCT06327100.
Reference
- “Lively Biotech receives optimistic suggestions on its scientific examine with tasquinimod in myelofibrosis,” by Lively Biotech. Information launch; Feb. 10, 2026.
Editor’s observe: This text is for informational functions solely and isn’t an alternative choice to skilled medical recommendation, as your personal expertise shall be distinctive. Use this text to information discussions along with your oncologist. Content material was generated with AI and reviewed by a human editor.
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