Active Biotech announces first patient dosed in the combination part of the phase Ib/IIa study of tasquinimod in multiple myeloma

Lund Sweden, February 7, 2022 - Active Biotech (NASDAQ STOCKHOLM: ACTI) today announced that the first patient has been dosed in the combination part of the phase Ib/IIa clinical study of tasquinimod in relapsed or refractory multiple myeloma. In this part of the study treatment with tasquinimod will be tested together with the orally administered antimyeloma agents ixazomib, lenalidomide, and dexamethasone (IRd).

Once an optimal dose and schedule of tasquinimod for the IRd combination is established, an expansion cohort will be recruited to further document the biological activity of tasquinimod in myeloma patients. Key secondary endpoints will include antimyeloma activity using the response criteria of the International Myeloma Working Group.

As previously communicated, the optimal dose and schedule of tasquinimod, when used as a single agent in patients with multiple myeloma, was established at 1 mg per day after a one-week run in of 0.5 mg daily. Tasquinimod was generally well tolerated and the established treatment schedule and safety profile of tasquiniomod in myeloma patients resembled that previously demonstrated in solid tumors.

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).

"We are pleased to have enrolled the first patient to the combination part of the study where tasquinimod will be combined with a standard anti-myeloma treatment regimen. Our preclinical laboratory models suggest that this combination strategy may be a particularly effective way to utilize tasquinimod in myeloma therapy," said Dr. Dan Vogl, Principal Investigator.

“The use of tasquinimod in combination with treatments used for earlier stage patients, is aligned with our current understanding of the mode of action of tasquinimod being able to block tumor sustaining signals from the bone marrow microenvironment. We are enthusiastic to follow the progress of the study ” said Helén Tuvesson, CEO, Active Biotech AB.

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

This information is information that Active Biotech AB is obliged to make public pursuant to the EU Market Abuse Regulation. This information was submitted for publication, through the agency of the contact person set out above, at 08.30 am CET on February 7, 2022.

About tasquinimodTasquinimod is an oral immunomodulatory and anti-angiogenic investigational treatment, that affects the tumor's ability to grow and metastasize. Tasquinimod is developed as a new immunomodulatory treatment for hematological malignances in the first step multiple myeloma. 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 or refractory multiple myeloma.

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 2017, 81000 new cases of multiple myeloma were diagnosed in the eight major markets. The global sales of drugs for the treatment of multiple myeloma totaled 18,6 billion USD in 2020 and is expected to increase to 22,2 billion USD in 2022 and 27,8 billion USD in 2027 (Global Data 2019).

About Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company that deploys its extensive knowledge base and portfolio of compounds to develop first-in-class immunomodulatory treatments for specialist oncology and immunology indications with a high unmet medical need and significant commercial potential. Following a portfolio refocus, the business model of Active Biotech aims to advance projects to the clinical development phase and then further develop the programs internally or pursue in partnership. Active Biotech currently holds three projects in its portfolio: Naptumomab, a targeted anti-cancer immunotherapy, partnered to NeoTX Therapeutics, is in a phase Ib/II clinical program in patients with advanced solid tumors. The small molecule immunomodulators, tasquinimod and laquinimod, both having a mode of actions that includes modulation of myeloid immune cell function, are targeted towards hematological malignancies and inflammatory eye disorders, respectively. Tasquinimod, is in clinical phase Ib/IIa for treatment of multiple myeloma. Laquinimod is in a clinical phase I study with a topical ophthalmic formulation, to be followed by phase II for treatment of non-infectious uveitis. Please visit www.activebiotech.com for more information.

Active Biotech AB(Corp. Reg. No. 556223-9227)Scheelevägen 22, SE-223 63 Lund, SwedenTel: +46 (0)46 19 20 00

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