Active Biotech AB

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.

“These results confirm the feasibility of combining tasquinimod in an all-oral combination with standard-of-care agents for patients with multiple myeloma who have exhausted other treatment options,” said Dr. Dan Vogl, Principal Investigator. In this analysis, a total of 17 patients received tasquinimod in combination with IRd. During dose-escalation, no dose-limiting toxicities were observed, and dose level two (tasquinimod 1 mg daily after a one week run-in at 0.5 mg daily) was selected as the dose for the expansion cohort. 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 pts) refractory to their most recent Imid/PI combination. Among these 12 patients, there was one durable Partial Response (PR) and three Minimal Responses (MR). These data are in line with previously reported results confirming the safety, tolerability and anti-myeloma effect of tasquinimod alone and in combination with IRd in patients with relapsed refractory multiple myeloma. ”Importantly, the observed responses in patients with myeloma previously refractory to an Imid/PI combination, who would not be expected to respond to the IRd backbone regimen, suggest synergistic efficacy of tasquinimod with IRd. These results highlight the potential for targeting the tumor microenvironment as a way to augment the efficacy of other myeloma therapies,” said Dr. Vogl. The study (NCT04405167), which is conducted at Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, has closed to enrolment, and the full study results are being analyzed. The abstract is available online on https://meetings.asco.org/ after 5 PM (ET) on May 22. Details on the presentation: Abstract Title: Clinical Activity of Novel Targeting of S100A9 with Tasquinimod for Relapsed and Refractory Multiple Myeloma (RRMM) Session Title: Hematologic Malignancies – Plasma Cell Dyscrasia Abstract Number: 7555 Session Date and Time: June 1, 2025, 8:00 AM-12:00 AM (ET)

“We are very pleased that this significant patent has been granted by the EPO. It is an important step in the development program for tasquinimod in hematological malignancies, with a primary focus on myelofibrosis,” said Active Biotech’s CEO Helén Tuvesson. The patent, with the European patent number, 4185292 provides protection and market exclusivity in strategic European markets through 2041 for the use of tasquinimod in treatment of myeloproliferative neoplasms (MPN) i.e. myelofibrosis. The patent, issued in the name of Erasmus University Medical Center (Erasmus MC), Rotterdam was licensed exclusively to Active Biotech from Oncode Institute, acting on behalf of Erasmus MC, in 2022.