TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company
Transcenta, Biologics, Antibody, Claudin 18.2
2020 - 04 - 20
Transcenta, a global biotherapeutics company that fully integrates antibody-based biotherapeutics discovery, R&D and manufacturing, today announced that its subsidiary Mabspace Biosciences (Suzhou) Co., Limited has received clearance of its IND from FDA for its novel humanized Claudin 18.2 (CLDN18.2) monoclonal antibody (internal project number TST001). It is developed jointly by Mabspace Biosciences and HJB, another Transcenta’s subsidiary focusing on CMC and manufacturing.
The unique expression profile of Claudin 18.2 in normal tissue and its aberrant expression in multiple tumor types make Claudin 18.2 an attractive anti-cancer therapeutic target. TST001 is a humanized high affinity anti-Claudin 18.2 antibody and kills tumor cells via antibody-dependent cellular cytotoxicity (ADCC). Through bioprocess engineering, TST001 is produced with reduced fucosylation and results in significant enhancement in its ADCC inducing activity against Claudin 18.2 expressing tumors. In preclinical studies, TST001 is efficacious in multiple tumor animal models, and well tolerated in GLP toxicology studies. As of today, TST001 has received clearance from both FDA and China National Medical Products Administration (NMPA) to initiate clinical trials in patients with metastatic solid tumors.
“The FDA’s clearance of our IND is an important milestone for TST001 project transition into clinical-stage. Our team is very excited to have the opportunity to test this differentiated Claudin 18.2 antibody in cancer patients. Our ongoing development of companion diagnostic antibody will help us to identify patients with Claudin 18.2 expression. We hope to expedite the development of this agent to bring potentially more efficacious treatment options to cancer patients around the world”, said Dr. Xueming Qian, Transcenta’s Co-Founder and Chief Executive Officer
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
Transcenta Announces Encouraging Phase I Clinical Data of TST002 (Blosozumab) in Chinese Patients with Reduced Bone Mineral Density