On January 3, 2023 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, reported 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) (Press release, Transcenta, JAN 3, 2023, View Source [SID1234625758]).
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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.