Regulatory press release

Active Biotech acquires exclusive rights to patents of tasquinimod in combination therapy

Lund, May 22, 2024 - Active Biotech (NASDAQ STOCKHOLM: ACTI) today announces it has entered into an exclusive license agreement with the Wistar Institute of Anatomy and Biology (“Wistar”), Philadelphia, US for the global rights to Wistars interest in the joint IP relating to the use of tasquinimod in combination therapy for multiple myeloma, for further development and commercialization.

Under the terms of the agreement, Wistar a non-profit corporation organized and existing under the laws of the Commonwealth of Pennsylvania grants Active Biotech a global exclusive license to develop and commercialize tasquinimod in combination therapy. Active Biotech will pay Wistar low single-digit royalties on its income in relation to in-market sales by Active Biotech or income generated from a partner agreement relating to the use of tasquinimod in multiple myeloma.

The expansion cohort of the phase Ib/IIa clinical study investigating tasquinimod in combination with a standard multiple myeloma oral regimen of ixazomib, lenalidomide, and dexamethasone (IRd) in patients with relapsed or refractory multiple myeloma is advancing towards results late in the year. The study is conducted in an academic partnership with the Abramson Cancer Center of the University of Pennsylvania, with Dr. Dan Vogl as principal investigator. Detailed information about the study is available on clinicaltrials.gov (NCT04405167).

"Licensing of these patent rights is an important step in the strategic direction of developing tasquinimod as a new treatment for hematologic malignancies. The ongoing clinical study with tasquinimod in combination therapy of patients with relapsed refractory myeloma shows reassuring signals of efficacy and safety and we look forward to completing the study towards the end of this year” said Helén Tuvesson CEO of Active Biotech.

“The results from the myeloma trial strengthen our belief that tasquinimod can effect blood cancers where the bone marrow microenvironment is driving the disease, which is encouraging ahead of our start of studies in myelofibrosis, a rare blood cancer with high medical need” said Erik Vahtola CMO of Active Biotech.

About Active Biotech

Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company that develops first-in-class immunomodulatory treatments for oncology and immunology indications with a high unmet medical need and significant commercial potential. Active Biotech currently holds three projects in its portfolio, of which tasquinimod and laquinimod are wholly owned small molecule immunomodulators with a mode of action that includes modulation of myeloid immune cell function. The projects are in clinical development for hematological malignancies and inflammatory eye disorders, respectively. The company's core focus is on the development of tasquinimod in myelofibrosis, a rare blood cancer, where clinical proof-of-concept studies are being prepared. Also ongoing is a clinical Phase Ib/IIa study in multiple myeloma. Laquinimod is in clinical development for the treatment of non-infectious uveitis. A clinical phase I program with a topical ophthalmic formulation is ongoing to support phase II development together with a partner. The third pipeline project is naptumomab, a targeted anti-cancer immunotherapy, partnered to NeoTX Therapeutics, which 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. Clinical studies with tasquinimod in patients with myelofibrosis are planned to start in 2024.