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Actuate Therapeutics Receives FDA Orphan Drug Designation for Elraglusib

13 Sep 2024
Admin
News Article

Actuate Therapeutics Receives FDA Orphan Drug Designation for Elraglusib

Actuate Therapeutics Receives FDA Orphan Drug Designation for Elraglusib in Soft Tissue Sarcomas

Overview

Actuate Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for elraglusib, a novel GSK-3β inhibitor, for the treatment of soft tissue sarcoma (STS).

About Elraglusib

Elraglusib, the lead investigational drug, targets molecular pathways in cancer that drive tumor growth and resistance to conventional therapies like chemotherapy, including several DDR pathways.
It is designed to enhance anti-tumor immunity by inhibiting NF-kB and regulating immune checkpoints and immune cell function.
As a prominent GSK-3β inhibitor, elraglusib has shown a favorable safety profile and antitumor activity across various solid tumors, including melanoma, Ewing sarcoma, colorectal cancer, and pancreatic cancer.

Soft Tissue Sarcomas

Soft tissue sarcomas are a rare and heterogeneous group of tumors, with over 70 histological subtypes identified, making treatment challenging.
Surgery remains the most effective option for localized sarcomas, with a median survival rate of about 50 percent.

However, for patients with metastatic disease, the median overall survival is just 6-12 months, underscoring the difficulty of treatment. Doxorubicin, the standard first-line treatment for nearly 50 years, offers minimal antitumor activity, highlighting the significant unmet medical need for better treatments in metastatic STS.