Transcenta Received IND Clearance from NMPA for Its First-In-Class Gremlin1 Targeting Antibody TST003 for the Treatment of Solid Tumors

SUZHOU, China, Jan. 4, 2023 /PRNewswire/ — 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 TST003, its first-in-class, high affinity humanized monoclonal antibody targeting Gremlin1, has received IND clearance from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA).

Transcenta presented the latest progress of TST003 program at the 10th TEMTIA meeting in October 2022. Preclinical data showed that TST003 blocks EMT and displays potent single agent anti-tumor activities in PDX models of multiple difficult-to-treat solid tumors. TST003 also received its IND clearance from U.S. Food and Drug Administration (FDA) in September, 2022.

In May 2022, Nature Cancer published the study results by Transcenta and Shanghai Jiao Tong University scientists on the potential application of the its first-in-class Gremlin1 targeting antibody TST003 in the treatment of androgen receptor-negative/low prostate cancer. The study results revealed that Gremlin1 protein can promote lineage plasticity and drive castration resistance in prostate cancer. Gremlin1-specific antibodies can effectively control tumor growth in androgen receptor-negative/low prostate cancer. The study also demonstrated a synergistic activity between the anti-Gremlin1 antibody and enzalutamide against patient-derived castration-resistant prostate cancer models in vitro and in vivo.

"Targeting Gremlin1 with our antibody TST003 has the potential to be transformative in the treatment of high unmet need cancer indications, such as castration resistant prostate cancer. As we get ready to initiate our first time in human clinical study in the U.S., getting the authorization to proceed from the NMPA is a critical step to deliver on Transcenta’s ambition to have an international development strategy fulfilling both U.S. and China health authorities requirements." said Dr. Caroline Germa, Transcenta’s Executive Vice President, Global Medicine Development and Chief Medical Officer.

About TST003

TST003 is a high affinity monoclonal antibody targeting Gremlin1, a member of TGFb superfamily. Gremlin1 protein is a highly conserved secreted protein and has shown to play important roles during development.  Gremlin1 is highly upregulated in multiple solid tumors. Gremlin1 protein promotes epithelial mesenchymal transition. TST003 has shown promising single agent activities in patient-derived xenograft tumor models of multiple difficult-to-treat solid tumors resistant to checkpoint inhibitor including castration resistant prostate cancer and microsatellite stable colorectal cancer. TST003 also enhanced the anti-tumor activity of checkpoint inhibitor in syngeneic tumor model.

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 Princeton, US and in Beijing, Shanghai and Guangzhou of China, 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.

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