Lund, December 1, 2023 - Active Biotech (NASDAQ STOCKHOLM: ACTI) announced today that a recorded presentation and an interview on the positioning of tasquinimod in the evolving landscape of myelofibrosis with Professor Rebekka Schneider-Kramann are available on the company website (www.activebiotech.com).

Active Biotech has communicated earlier that it will focus its project pipeline on the development of tasquinimod in myelofibrosis and is planning to start two clinical phase II studies in myelofibrosis in 2024. Professor Schneider-Kramann will act as the Lead Principal Investigator for the European study named TasqForce, planned to start during the first half of 2024.

“Our preclinical data suggest that tasquinimod holds potential as a disease modifying treatment in myelofibrosis. I am thrilled to get the clinical trial started based on our preclinical data with tasquinimod. It was always my dream that our findings in the lab will be translated to better outcomes in patients and hopefully help to ameliorate the life-threatening condition of bone marrow fibrosis,” said Professor Schneider-Kramann.

In the presentation, Professor Schneider-Kramann gives an overview of the disease and shares her preclinical research results with tasquinimod in animal models of myelofibrosis. Tasquinimod treatment resulted in inhibition of bone marrow fibrosis, normalization of spleen size and white blood cell counts, which are hallmarks of the disease (Leimkuhler et al., Cell Stem Cell. 2021 Apr 1;28(4):637-652).

The results provide a strong rationale to initiate a phase II clinical trial in patients with myelofibrosis who are ineligible to JAK inhibitor therapy. The recording will end with Dr. Erik Vahtola, MD, PhD, CMO Active Biotech, interviewing Rebekka Schneider about her view on the medical need and potential positioning of tasquinimod in myelofibrosis.

The recording is available on Active Biotech Audiocast 2023 (financialhearings.com). You can find a 2-page summary of the presentation here https://www.activebiotech.com/wp-content/uploads/Two-page_summary_tasquinimod_in_myelofibrosis_ENG_2023.pdf

For further information, please contact:

Helén Tuvesson, CEO, +46 46 19 21 56, helen.tuvesson@activebiotech.com
Hans Kolam, CFO, +46 46 19 20 44, hans.kolam@activebiotech.com

About Active Biotech

Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company that deploys its extensive knowledge base and portfolio of compounds to develop first-in-class immunomodulatory treatments for specialist oncology and immunology indications with a high unmet medical need and significant commercial potential. Following a portfolio refocus, the business model of Active Biotech aims to advance projects to the clinical development phase and then further develop the programs internally or pursue in partnership. Active Biotech currently holds three projects in its portfolio: The wholly owned small molecule immunomodulators, tasquinimod and laquinimod, both having a mode of actions that includes modulation of myeloid immune cell function, are targeted towards hematological malignancies and inflammatory eye disorders, respectively. Tasquinimod, is in clinical phase Ib/IIa for treatment of multiple myeloma. Laquinimod is in clinical development for treatment of non-infectious uveitis and a clinical phase I study with a topical ophthalmic formulation has been concluded. Naptumomab, a targeted anti-cancer immunotherapy, partnered to NeoTX Therapeutics, is in a phase Ib/II clinical program in patients with advanced solid tumors. Please visit www.activebiotech.com for more information.

About tasquinimod

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 as a new immunomodulatory treatment for hematological malignances. Tasquinimod has previously been studied as an anti-cancer agent in patients with solid cancers, including a phase III randomized trial in patients with metastatic prostate cancer. The tolerability of tasquinimod is well-characterized based on these previous experiences. Tasquinimod has demonstrated a clear therapeutic potential in preclinical models of multiple myeloma, when used as a single agent and in combination with standard multiple myeloma therapy. A clinical Phase Ib/IIa study is ongoing with tasquinimod in relapsed and refractory multiple myeloma. Tasquinimod ameliorates disease development in preclinical models for myelofibrosis. In February 2022 Active Biotech entered into an exclusive license agreement with Oncode Institute, a foundation acting on behalf of Erasmus Universiteit Medisch Centrum (Erasmus MC) to develop and commercialize tasquinimod in myelofibrosis. A clinical study with tasquinimod in patients with myelofibrosis is planned to start in the first half of 2024.

About myelofibrosis

Myelofibrosis (MF) is a rare blood cancer belonging to a group of disorders called myeloproliferative neoplasms. The underlying cause of MF is unknown. The estimated annual incidence of MF is 0.4 - 1.3 cases per 100 000 people in Europe. 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.

About Professor Rebekka Schneider-Kramann

Univ.-Prof. Dr. med. Rebekka Schneider-Kramann, PhD Director, Institute of Cell and Tumor Biology at the University Hospital in Aachen, Germany Oncode Principal Investigator, Oncode Institute and Associate Professor, Cancer Center Erasmus MC, Rotterdam, The Netherland. Before starting her own research group at the Erasmus MC, Rebekka worked as a post-doc researcher in Benjamin Ebert‘s lab at Harvard Medical School between 2012 and 2015. Her research is focused on the role of the microenvironment in the bone marrow in myeloid malignancies and she has 93 publications in peer reviewed journals.

Attachments

Lead Principal Investigator Rebekka Schneider-Kramann presents the clinical plan and positioning of tasquinimod in myelofibrosis

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