Announcement • Jul 25

Active Biotech Doses First Patient in Amended Ho172 Clinical Study of Tasquinimod in Myelofibrosis

Active Biotech announced that the first patient has been dosed in the Phase Ib/II clinical study of tasquinimod following an amendment to the study protocol, with increased flexibility in the dosing regimen of tasquinimod. The study evaluates tasquinimod in patients with myelofibrosis who are refractory to, or ineligible for, treatment with JAK2 inhibitors. The protocol amendment, which was approved by the European Medicines Agency (EMA) and relevant ethics committees, introduces increased flexibility in the dosing regimen of tasquinimod. The updated regimen is designed to better reflect previously established dosing schedules from earlier clinical studies, including the Phase III prostate cancer program. The clinical study evaluates tasquinimod as monotherapy in patients with myelofibrosis. It is conducted within the Stichting Haemato-Oncologie Volwassenen Nederland (HOVON) network of clinical centers across the Netherlands and Germany, with HOVON acting as the legal sponsor. Active Biotech entered into a global patent license agreement with Oncode Institute in February 2022, covering the development of tasquinimod in myelofibrosis. The current study is supported through Oncode Institute’s Clinical Proof-of-Concept program, which aims to accelerate the translation of innovative cancer research into clinical applications through close collaboration between academia, clinical centers, and industry partners. Tasquinimod is an orally active small molecule immunomodulator with a novel mode of action, blocking tumor supporting pathways in the bone marrow microenvironment. Tasquinimod is being developed for the treatment of blood cancers, with focus on myelofibrosis. Tasquinimod has previously been studied in patients with solid cancers, including a phase II-III program in patients with metastatic prostate cancer. The safety profile of tasquinimod is well-characterized based on these previous clinical studies. Tasquinimod reduces myeloproliferation, splenomegaly, and fibrosis in preclinical models of myelofibrosis, and demonstrates efficacy both as monotherapy and in combination with approved therapies. Clinical proof-of-concept studies have been initiated in Europe and in the US. Myelofibrosis (MF) is a rare blood cancer belonging to a group of disorders called myeloproliferative neoplasms. The estimated annual incidence of MF is approximately 1.5 cases per 100,000 people in EU, US, UK, and Japan. Patients with MF have an abnormal production of blood-forming cells leading to the replacement of healthy bone marrow with scar tissue (fibrosis). Due to the lack of normal blood cell production patients typically present with laboratory value abnormalities such as anemia and changes in white blood cell counts and blood cell-differentiation. Later symptoms include enlargement of the spleen, an increased risk for infections, night sweats and fever. MF is associated with shortened survival and causes of death include bone marrow failure and transformation into acute leukemia. MF can be treated with bone marrow transplantation for eligible individuals, erythropoietin to manage anemia and JAK inhibitors to reduce spleen size. At present there are no approved therapies that would reverse bone marrow fibrosis in MF.

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