Press release

Active Biotech reports study results with tasquinimod in heavily pre-treated patients with relapsed refractory multiple myeloma

Lund, May 23, 2025 – Active Biotech (NASDAQ Stockholm; ACTI) announced today study results of tasquinimod in combination with ixazomib (proteasome inhibitor, PI), lenalidomide (Imid) and dexamethasone (IRd) in heavily pre-treated patients with relapsed refractory multiple myeloma. The results confirm that tasquinimod has anti-myeloma activity and is well tolerated in patients previously refractory to Imid/PI combination therapy. The results will be presented as a poster at the American Society of Clinical Oncology (ASCO) annual meeting on June 1, 2025.

“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)

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.

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 with tasquinimod in relapsed and refractory multiple myeloma is beeing concluded. Tasquinimod ameliorates disease development in preclinical models for myelofibrosis. Clinical proof-of-concept studies have been initiated in Europe and in the US.

About multiple myeloma

Multiple myeloma is an incurable blood cancer in which abnormal plasma cells in the bone marrow grow uncontrollably while other blood forming cells such as white and red blood cells and blood platelets are suppressed. This leads to anemia, infections, destruction of bone tissue and progressive loss of renal function. Despite new treatments have greatly improved survival of multiple myeloma patients, the biological heterogeneity of the disease and the emergence of drug resistance is a major challenge, and the medical need of innovative treatment modalities remains high. In 2022, 317,000 new cases of multiple myeloma were diagnosed in the eight major markets. The global sales of drugs for the treatment of multiple myeloma totaled 21.2 billion USD in 2022 and is expected to increase to 29.3 billion USD in 2032 (Global Data Report 2024).