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Transcenta was Selected to Present the Preclinical Data of TST004 at the 2022 ISN Frontiers Meetings of Complement Related Kidney Diseases

2022 - 06 - 28

SUZHOU, China, June 28, 2022,Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that it was selected to present the preclinical data of TST004 at the 2022 ISN Frontiers Meetings of Complement-Related Kidney Diseases in Bergamo, Italy.

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. 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), 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.

Dr. Xueming Qian presented the poster which highlighted the following preclinical data:

  • TST004 binds to MASP2 selectively in high affinity.

  • TST004 showed more potent in vitro and in vivo blocking activities for the MASP2 dependent lectin complement pathway than benchmark.

  • TST004 displayed more prolonged target inhibition than benchmark in Cyno monkey PK/PD study.

  • TST004 displayed excellent tolerability and safety profiles in NHP in single and repeated dose toxicity studies following subcutaneous administration.

TST004 is to be delivered as subcutaneous injection which could provide significant advantage over IV-infusion based delivery utilized by benchmark antibody being studied in clinical trial.

"IgA nephropathy (IgAN) is a disease highly prevalent globally and an area with high unmet medical needs. The preclinical data provide a compelling scientific rationale for TST004 to be further evaluated as a potential treatment for complement dependent diseases such as immunoglobulin A nephropathy (IgAN) and hematopoietic stem-cell transplantation-associated thrombotic microangiopathy (HSCT-TMA)." said Dr. Xueming Qian, CEO of Transcenta. "We are working to advance TST004 into clinical development, hoping that it can benefit more patients with critical unmet medical needs."

About TST004

TST004 is a humanized mAb targeting mannose-binding protein-associated serine protease 2 (MASP2) and designed to prevent the lectin pathway complement-mediated inflammation. Transcenta discovered and developed TST004 in-house and plan to develop TST004 for IgA nephropathy (IgAN), a highly prevalent 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 antibody-based biotherapeutics discovery, research, development and manufacturing.

Transcenta has established global footprint, with Headquarters and Discovery, Clinical and Translational Research Center in Suzhou, Process and Product Development Center and Manufacturing Facility in Hangzhou, and Clinical Development Centers in Beijing, Shanghai and Guangzhou in China and in Princeton, US, and External Partnering Center in Boston and Los Angeles, US. Transcenta has also initiated the construction of the Group Headquarters and the second high-end biopharmaceutical facility with ICB as its core technology in Suzhou Industrial Park. Transcenta is developing ten therapeutic antibody molecules for oncology and selected 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 news 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, as they relate to Transcenta, are intended to identify certain of such forward-looking statements. Transcenta does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Transcenta with respect to future events at the time these statements are made. These statements are not a guarantee 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. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Transcenta's competitive environment and political, economic, legal and social conditions.

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