Tasquinimod

Lund Sweden, July 24, 2026 – Active Biotech (NASDAQ STOCKHOLM: ACTI) today 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. “I am very pleased that the first patient has now been dosed following regulatory approval of the protocol amendment. The amended study design provides greater flexibility in the dosing regimen of tasquinimod, which we believe will facilitate patient management and study conduct. We look forward to following the progress of the trial and further evaluating the potential of tasquinimod in patients with myelofibrosis who have limited treatment options,” said Co-Investigator Dr Martina Crysandt. 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. For more information on the study, see clinicaltrials.gov (NCT06605586), the HOVON website www.hovon.nl

“We are very pleased with the favorable and supportive response from the authorities to our protocol amendment. This is an important step forward for our proof-of-concept study evaluating tasquinimod in patients with myelofibrosis,” said Active Biotech’s CMO Erik Vahtola. “Bringing our research to the clinic has always been my ambition. With the HO172 tasquinimod study, we are translating years of fundamental research into a clinical setting for patients with myelofibrosis. Through the strong support of Oncode Institute and our collaboration with HOVON and Active Biotech, we are accelerating the development of a potential new treatment option for patients with limited therapeutic alternatives,” said Rebekka Schneider, Oncode Investigator and haematologist at Erasmus MC. “The approval of this amendment allows us to safely and responsibly continue this study within the HOVON framework. It reflects our commitment to high‑quality investigator‑initiated research and enables the careful evaluation of promising scientific insights through close collaboration with academic and industry partners, for patients with myelofibrosis who have limited treatment options,” said Marleen Breems, CEO, HOVON. A protocol amendment was submitted to the authorities and ethics committee, with the aim to increase the flexibility in the dosing regimen of tasquinimod, closely reflecting the schedule of tasquinimod previously used in the phase III prostate cancer study. With the amendment now approved, the study is well positioned to move forward, and recruitment will resume shortly. The clinical study evaluates tasquinimod as a monotherapy in patients with myelofibrosis who are refractory or ineligible to JAK2 inhibitors. The study is conducted within the Stichting Haemato-Oncologie Volwassenen Netherland (HOVON) network of study centers in the Netherlands and Germany, with HOVON as the legal sponsor. Active Biotech entered into a global patent license agreement with Oncode Institute for tasquinimod in myelofibrosis in February 2022. The current study is supported through Oncode Institute’s Clinical Proof-of-Concept (CPoC) programme, which aims to accelerate the translation of promising cancer research into clinical applications for patients through close collaboration between academia, clinical centres and industry partners. For more information regarding the clinical study, see www.clinicaltrials.gov NCT06327100.