Lund, Sweden - July 8, 2025 -Active Biotech (NASDAQ Stockholm: ACTI) today provided a status update of its development programs with laquinimod in inflammatory eye disorders and tasquinimod with the core focus in myelofibrosis. We have communicated progress in the clinical development programs for both drug candidates recently, and a majority of the planned clinical milestones 2025 have been executed.
In the laquinimod project, we announced topline data from the biodistribution LION study in early May, and most recently an interview with the principal investigators of the study was published. The results from the LION study convincingly demonstrate that laquinimod, at a therapeutic concentration, reaches the back of the eye when administered topically as an eye drop formulation. There is a high unmet need for non-invasive local delivery of therapeutic agents for use in the treatment of inflammatory eye diseases such as non-infectious uveitis and diseases with excessive neovascularisation like wet AMD.
Our key priority for the laquinimod program is now to secure a commercial partnership for the continued clinical development of laquinimod in inflammatory eye diseases with significant medical need. In June, a publication titled Laquinimod treatment attenuates EAU by inhibiting both the inductive and effector phases in an APC-dependent manner was released (preview available at bioRxiv). The work was carried out in collaboration with Dr. Rachel Caspi's world leading group of at the NEI/NIH and provides the mechanistic basis for the effect of laquinimod in inflammatory eye disorders.
In the myelofibrosis studies with tasquinimod in US and Europe, the first patients were recruited in the beginning of 2025. The protocols for both studies are presently being amended to allow an initial dose-titration regimen with both up- and down-regulation of dosing for increased flexibility in the clinical management of the patients.
In the US study the combination of tasquinimod with the newly marketed JAK inhibitor momelotinib is included in the combination cohort. During this process recruitment is paused. Enrollment to the studies will be restarted as soon as we have clearance from the Regulatory Authorities and Ethical Committees in the US and Europe. Myelofibrosis is a very rare haematological malignancy with low patient recruitment rate and thus we do not foresee major changes to the projected study times lines.
Data from the multiple myeloma study at Abramson Cancer center were reported in early June at ASCO, the world's leading cancer congress. The data from the combination with a standard oral treatment IRd demonstrate the effect of tasquinimod on the tumor microenvironment in the bone marrow and support a role for tasquinimod also in myelofibrosis. The full study data will be submitted for publication in a peer reviewed Journal.
Presentations from the recently reported events are available on Active Biotech's website.
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 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 have been initiated. A clinical Phase Ib/IIa study in multiple myeloma is being concluded. Laquinimod is in clinical development for the treatment of non-infectious uveitis. A clinical phase I program with a topical ophthalmic formulation has been performed 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.
