Tasquinimod

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.

Lund, June 9, 2025 – Active Biotech (NASDAQ Stockholm; ACTI) announced today that study results of its clinical drug candidate tasquinimod in heavily pretreated patients with relapsed refractory multiple myeloma (RRMM) are now available on Active Biotech’s website. The results were presented in a poster at the American Society of Clinical Oncology (ASCO) annual meeting May 30 – June 1, 2025. A total of 17 patients received tasquinimod in combination with ixazomib (proteasome inhibitor, PI), lenalidomide (Imid), and dexamethasone (IRd). Patients were heavily pretreated with a median of 7 prior lines of therapy (range 4-19) and all were triple-class refractory with 71% (12 patients) refractory to their most recent Imid/PI combination. In the total combination cohort, there was one partial response and 7 minimal responses which resulted in a 47% Clinical Benefit Rate (CBR). Among the 12 patients refractory to their latest Imid/PI combination there was one durable partial response (lasting 19.8 months) and three minimal responses (lasting 1.2, 1.5 and 6.7 months) resulting in a CBR of 33%. These patients were unlikely to respond to IRd alone and the result suggests synergistic efficacy of tasquinimod with the IRd combination. The results highlight the potential for targeting the tumor microenvironment with tasquinimod to augment the efficacy of other myeloma therapies. Tasquinimod was well tolerated in combination with IRd and the safety profile was in line with previous experience. The most common treatment emergent adverse events included fatigue, gastrointestinal events, pain and respiratory infections. Mostly of mild to moderate grade. The study (NCT04405167), was conducted at Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA with Dr. Dan Vogl as Principal Investigator. Full study results are being analyzed and will be published in a Scientific Journal. Information on the presentation: Abstract 7555, Clinical Activity of Novel Targeting of S100A9 with Tasquinimod for Relapsed and Refractory Multiple Myeloma (RRMM), Dan T. Vogl et al. was presented as a poster at the poster session Hematologic malignancies – Plasma cell dyscrasia on June 1, 2025. The poster is now available on Active Biotech’s website.