Transcenta monoclonal antibody gets FDA clearance

October 5, 2022 - 2 minutes
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Transcenta Holding Limited says its TST004 humanized monoclonal antibody targeting MASP2, has received IND clearance from the U.S. Food and Drug Administration (FDA).

MASP2, mannose-binding protein-associated serine protease 2, is a key enzyme in the lectin pathway initiation of complement activation. Studies have shown that lectin pathway activation contributes to multiple human diseases such as immunoglobulin A nephropathy (IgAN) and hematopoietic stem-cell transplantation–associated thrombotic microangiopathy (HSCT-TMA). 

Therefore, inhibition of MASP2 might be a potential treatment approach for diseases related to lectin pathway activation.

TST004 is a humanized mAb targeting mannose-binding protein-associated serine protease 2 (MASP2) and designed to prevent the inflammation and tissue damage mediated by lectin pathway complement activation.

“There is a high unmet medical need for patients with IgA nephropathy, with around 30 to 45% of them ultimately developing end stage kidney disease and available treatment options remaining symptomatic in nature. Targeting the lectin pathway activation with our best-in-class TST004 antibody is a potentially transformative therapeutic alternative.” said Caroline Germa, Transcenta’s executive vice president, global medicine development and chief medical officer.

About Transcenta’s TST004

TST004 is a humanized mAb targeting mannose-binding protein-associated serine protease 2 (MASP2) designed to prevent lectin pathway complement-mediated inflammation. 

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Transcenta discovered and developed TST004 in-house and plans to develop TST004 for IgA nephropathy, a highly prevalent chronic kidney disease with very limited treatment options. TST004 also has therapeutic potential in other indications, such as thrombotic microangiopathy (TMA), representing significant market potential.

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