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Active Biotech announces first patient dosed in phase 1b/2a study of tasquinimod use in treatment of multiple myeloma

Lund Sweden, August 3, 2020 - Active Biotech (NASDAQ STOCKHOLM: ACTI) today announces that the first patient has been dosed in the phase 1b/2a clinical study of tasquinimod for treatment of relapsed or refractory multiple myeloma. The study, which is planned to recruit up to 54 patients, will establish a maximum tolerated dose of tasquinimod as single agent and then investigate tasquinimod in combination with a standard multiple myeloma oral regimen of ixazomib, lenalidomide, and dexamethasone (IRd). For both single agent tasquinimod and the combination of tasquinimod and IRd, exploratory expansion cohorts will be enrolled to characterize the anti-myeloma activity of each regimen.

The primary objective of the study is to establish the optimal dose and treatment schedule of tasquinimod when used as a single agent and in combination with IRd. Key secondary endpoints include preliminary antimyeloma activity using the response criteria of the International Myeloma Working Group.

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 excited to have initiated this trial based on compelling preclinical data showing that tasquinimod can block tumor-sustaining signals from the bone marrow microenvironment. We hope that tasquinimod shows efficacy for patients with relapsed or refractory myeloma, who need additional treatment options," says Dr. Dan Vogl, Principal Investigator.

“We are very pleased to have reached the milestone of first patient dosed in this study, undertaken in collaboration with the Abramson Cancer Center, University of Pennsylvania. Due to exciting and comprehensive preclinical data developed in collaboration with the the Wistar Institute in Philadelphia there is clear potential for an important role of tasquinimod both as monotherapy and in combination with standard multiple myeloma therapy. We look forward to following the progress of this study,” says Helén Tuvesson, CEO, Active Biotech AB.

Lund 3 August, 2020

Helén Tuvesson
President & CEO

For further information, please contact:
Helén Tuvesson, CEO
Tel +46 46 19 21 56
Hans Kolam, CFO
Tel +46 46 19 20 44

About tasquinimod
Tasquinimod 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 multiple myeloma. Tasquinimod has previously been studied as an anti-cancer agent in patients with solid cancers, including a phase 3 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.

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 multiple myeloma totaled USD 16 billion in 2017 and sales are expected to increase 48% by 2026 (ref Global Data 2019).

Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company with focus on cancer and autoimmune/inflammatory diseases. Naptumomab, an immunotherapy licensed to NeoTX Therapeutics Ltd., is in clinical phase 1b/2 development for treatment of solid tumors, NCT03983954. Tasquinimod, an oral immunomodulator, is in clinical development for treatment of multiple myeloma, NCT04405167. Laquinimod, an immunomodulator, is evaluated as a potential treatment of the eye disorders wet AMD and uveitis and the inflammatory bowels disease, Crohn’s disease. Please visit www.activebiotech.com for more information.

Active Biotech AB
(Corp. Reg. No. 556223-9227)
Box 724, SE-220 07 Lund, Sweden
Tel: +46 (0)46 19 20 00

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 a.m. CET on August 3, 2020.

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