Transcenta monoclonal antibody gets FDA clearance

kidneys kidney disease

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. 

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.

Explore other topics: AntibodiesFDA

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