Transcenta Receives IND Clearance from the FDA for its Best-in-Class MASP2 Targeting Antibody TST004 for the Treatment of IgA Nephropathy

SUZHOU, China, Oct. 4, 2022 /PRNewswire/ — Transcenta Holding Limited (“Transcenta”) (HKEX: 06628), a clinical-stage biopharmaceutical company with fully integrated capabilities in the discovery, research, development and manufacturing of antibody-based therapeutics, announces that TST004, its best-in-class target of humanized MASP2 monoclonal antibodies, received IND clearance from US Food and Drug Administration (FDA).

MASP2, the mannose-binding protein-associated serine protease 2, is a key enzyme in the initiation of the lectin pathway of complement activation. Studies have shown that activation of the lectin pathway contributes to multiple human diseases such as immunoglobulin A nephropathy (IgAN), thrombotic microangiopathy associated with hematopoietic stem cell transplantation (HSCT-TMA). Therefore, inhibition of MASP2 could be a potential therapeutic 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 inflammation and tissue damage mediated by complement activation of the lectin pathway.

In June 2022, Transcenta was selected to present preclinical data for TST004 at the ISN Frontiers Meetings of Complement-Related Kidney Diseases 2022 in Bergamo, Italy: https://www.transcenta.com/newsDet/id-93

“There is a high unmet medical need for patients with IgA nephropathy, with an estimated 30-45% of them eventually developing end-stage kidney disease and available treatment options remaining symptomatic in nature. Targeting the Activation of the lectin pathway with our best TST004 antibody is a potentially transformative therapeutic alternative.” said Dr. Caroline Germa, Transcenta’s Executive Vice President, Global Drug Development and Chief Medical Officer.

About TST004

TST004 is a humanized mAb targeting mannose-binding protein-associated serine protease 2 (MASP2) and designed to prevent complement-mediated inflammation of the lectin pathway. Transcenta discovered and developed TST004 in-house and plans to develop TST004 for IgA nephropathy (IgAN), a very common chronic kidney disease with very limited treatment options. TST004 also has therapeutic potential in a number of other indications, such as thrombotic microangiopathy (TMA), representing significant market potential.

About Transcenta Holding Limited

Transcenta (HKEX: 06628) is a clinical-stage biopharmaceutical company with fully integrated capabilities in the discovery, research, development and manufacturing of antibody-based biotherapeutics.

Transcenta has established a global footprint, with a headquarters and discovery center, a clinical and translational research center in Suzhou, a process and product development center and manufacturing facility in Hangzhou, and clinical development centers in Princeton, USA and in Beijing, Shanghai and Guangzhou in China, and external centers Partner Center in Boston and Los Angeles, USA. Transcenta also launched the construction of the group headquarters and the second high-end biopharmaceutical facility with ICB as the core technology in Suzhou Industrial Park. Transcenta is developing ten therapeutic antibody molecules for oncology and certain non-oncology indications, including bone and kidney disorders.

For more information, please visit www.transcenta.com and https://www.linkedin.com/company/transcenta.

Forward-looking statements

This press release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, “intend” and similar expressions, with respect to Transcenta, are intended to identify certain of these forward-looking statements. Transcenta does not intend to regularly update these forward-looking statements.

These forward-looking statements are based on Transcenta’s management’s existing beliefs, assumptions, expectations, estimates, projections and understandings regarding future events at the time such statements are made. These statements are not guarantees of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Transcenta’s control and are difficult to predict. Accordingly, actual results may differ materially from the information contained in the forward-looking statements due to changes or future developments in our business, Transcenta’s competitive environment and political, economic, legal and social conditions.

Transcenta, the directors and employees of Transcenta assume (a) no obligation to correct or update any forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements do not materialize or prove to be incorrect.

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SOURCETranscenta Holding Limited


Company Codes: Hong Kong: 6628

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