TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company
Transcenta, Biologics, Antibody, Claudin 18.2
2023 - 03 - 23
March. 23, 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, announces the successful dosing of first patient in the U.S. Phase I Study of TST003 (NCT05731271), its first-in-class, high affinity humanized monoclonal antibody targeting Gremlin1, for the treatment of solid tumors.
NCT05731271 is an open-label, dose escalation, FIH study designed to evaluate the safety, tolerability, and pharmacokinetics profile of TST003 as a treatment in patients with solid tumors.
TST003 is a high affinity monoclonal antibody targeting Gremlin1, a member of the TGF-b superfamily. Gremlin1 protein is a highly conserved secreted protein and has shown to play important roles during embryonic development and promote epithelial mesenchymal transition. Gremlin1 is upregulated in multiple solid tumors. TST003 has demonstrated promising single agent and combination activities in patient-derived xenograft tumor models from the difficult-to-treat solid tumors resistant to checkpoint inhibitors including castration resistant prostate cancer and microsatellite stable colorectal cancer.
“The enrollment and dosing of the first patient in the U.S. marks a very significant milestone for TST003: our carefully designed Phase 1 will provide the necessary clinical and translational data to achieve the full potential of targeting Gremlin1 as a single agent or in combinations with standard of care, in particular in indications with high unmet need like MSS CRC or CRPC.” said Dr. Caroline Germa, Transcenta’s Executive Vice President, Global Medicine Development and Chief Medical Officer.
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.
Transcenta Unveils Updated Efficacy Data from Osemitamab (TST001) Plus CAPOX as First-Line Treatment for G/GEJ Cancer Study at ESMO 2023
FDA Grants Transcenta Clearance to Proceed with Global Phase III Trial of Osemitamab (TST001) as First-Line Treatment for Gastric/Gastroesophageal Cancer Patients
Transcenta Anti-sclerostin Monoclonal Antibody TST002 (Blosozumab) Received Approval from China CDE to Initiate Phase II Clinical Trial in Patients with Reduced Bone Mineral Density
Transcenta Received Approvals from China CDE and South Korea MFDS to Initiate TranStar 301 Global Phase III Pivotal Trial of Osemitamab (TST001)
Transcenta Presented PFS Data by CLDN18.2 Expression Level from Phase I/II Study of Osemitamab (TST001) plus CAPOX as the First-Line Treatment of Advanced G/GEJ Cancer at 2023 ESMO GI Annual Congress
Transcenta Presents Updated Data of Osemitamab (TST001) in Combination with CAPOX as a First-Line Treatment of G/GEJ Cancer at 2023 ASCO Annual Meeting