Transcenta Announces First Patient Dosed in the U.S. Study of Its First-In-Class Gremlin1 Targeting Antibody TST003 for the Treatment of Solid Tumors

On March 22, 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 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 (Press release, Transcenta, MAR 22, 2023, View Source [SID1234629174]).

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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-β 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.