Active Biotech’s clinical trial of tasquinimod in myelofibrosis approved in Europe

Lund, Sweden, October 30, 2024 – Active Biotech (NASDAQ STOCKHOLM: ACTI) today announced that the clinical phase I/II study of Tasquinimod in Patients with Myelofibrosis Refractory to or Intolerant for JAK2 Inhibition (HOVON 172 MF) has received full approval from the European Medicines Agency (EMA) and the Institutional Ethics Committees.

“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”, said Dr. Erik Vahtola, CMO of Active Biotech.

The single-arm, multicenter open-label study will evaluate the safety and efficacy of tasquinimod given as mono theraphy to patients with myelofibrosis who have previously been treated with a JAK2 inhibitor or who are ineligible to JAK2 inhibitor treatment. The primary efficacy endpoint is the proportion of patients who achieve at least a 35% reduction in spleen volume after six 4-week cycles of tasquinimod.

The study will be conducted at the Stichting Haemato-Oncologie Volwassenen Netherland (HOVON) network of study centers in the Netherlands and Germany and HOVON is the legal sponsor of the study.

Active Biotech has a global patent license agreement with Oncode Institute for tasquinimod in myelofibrosis since February 2022. Oncode Institute will be the main financier of the study.

For more information on the study, see clinicaltrials.gov (NCT06605586), the HOVON website www.hovon.nl and the previously recorded interview with lead principal investigator Rebekka Schneider https://ir.financialhearings.com/active-biotech-2023

Datum 2024-10-30, kl 10:45
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