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A first-in-human, open-label, multi-center phase 1 study of TST003, a GREM 1 inhibitor, in subjects with locally advanced or metastatic solid tumors

10 Apr, 2024

Authors:

Ismael Rodriguez Rivera1, Lin Shen2, Shivaani Kummar3, Minal Barve4, Caroline Germa5, Chuan Qi6, Lei chen6, Jenny Milata5, Jenny Yao5, Li Shen6, Xuelian Zhu6 

1NEXT Oncology, San Antonio, TX,2Beijing Cancer Hospital, Beijing, China,3Division of Hematology and Medical Oncology, Oregon Health & Science University, Portland, OR, 4Mary Crowley Cancer Research Centers, Dallas, TX, 5Transcenta Therapeutics Inc., Princeton, NJ,6Suzhou Transcenta Therapeutics Co., Ltd, Shanghai, China

Background:

Gremlin-1 (GREM1), a member of the TGF-β superfamily, plays a key role in EMT, and cancer cell proliferation by binding to BMPs. GREM1 is widely expressed in various human cancers and TME stromal cells. Overexpression of GREM1 is correlated with poor prognosis. TST003 is a novel humanized IgG1 monoclonal antibody targeting GREM1 with high affinity and selectivity, and it blocks GREM1 binding to BMP2/4 resulting in enhanced BMP signaling. This study will investigate TST003's safety, tolerability, and preliminary anti-tumor activity in patients with advanced solid tumors.

Study Status:

The enrollment is ongoing in clinical centers in the US and China. No significant safety signals were reported in the first few patients treated with TST003. Clinical trial information: NCT05731271.