PRINCETON, N.J. and SUZHOU, China, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Transcenta Holding Limited (HKEX: 06628) ("Transcenta Therapeutics"), a global clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, today announced updated efficacy analysis of Cohort G by CLDN18.2 and PD-L1 expression from the phase I/II Transtar102 trial of osemitamab plus nivolumab and CAPOX in first-line Gastric/Gastroesophageal Junction (G/GEJ) cancer. The new findings were showcased in a poster presentation (Abstract #299P) at the ESMO Asia Congress 2025 in Singapore.
This new analysis reinforces the encouraging clinical benefit of the osemitamab triple combination regimen in the ongoing study. In the 26 patients with CLDN18.2 expression ≥40%, ≥2+ and known PD-L1 CPS, the median PFS reached 16.6 months, with an ORR of 68% and a median DoR of 18 months at a 25.8-month median follow-up. Notably, better PFS outcomes were observed in patients with higher CLDN18.2 expression compared to lower CLDN18.2 expressors in both PD-L1 CPS<1 and ≥1 subgroups, which indicated the potential treatment benefit of osemitamab is consistent regardless of PD-L1 expression.
The safety profile was similar to that previously presented at ASCO 2025.
“The exploratory efficacy analysis continues to show promising clinical benefit with osemitamab when combined with standard-of-care therapy,” said Professor Lin Shen, Director, Department of Gastrointestinal Oncology and Phase I Clinical Trial Center at Peking University Cancer Hospital; and Principal Investigator of the trial. “The consistency of benefit across different PD-L1 subgroups is particularly noteworthy and suggests that this regimen may offer meaningful improvement for a broad population of patients with advanced G/GEJ cancer.”
“We are encouraged to see the continued strength of the clinical signals in this study, which reinforce the potential of osemitamab to deliver meaningful benefit to patients in need of more effective treatment options,” said Dr. Charlie Qi, Executive Vice President, Head of Global Clinical Development at Transcenta. “Further, these updated data continue to demonstrate that the combination of osemitamab with nivolumab and CAPOX is safe and well tolerated as a first-line regimen for patients with advanced G/GEJ cancer.”
About Osemitamab
Osemitamab is a high affinity humanized anti-CLDN18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (“ADCC”). It has shown potent anti-tumor activities in tumor xenograft models. Osemitamab is the second CLDN18.2 targeting antibody being developed globally. Osemitamab was generated using Transcenta's Immune Tolerance Breaking Technology (IMTB) platform. Osemitamab kills CLDN18.2 expressing tumor cells by mechanisms of ADCC. Leveraging advanced bioprocessing technology, the fucose content of osemitamab was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of osemitamab. Osemitamab has been granted Orphan Drug Designation in the U.S. by FDA for the treatment of patients with gastric or gastroesophageal junction (G/GEJ) and pancreatic cancer.
About Transcenta Therapeutics
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 China, U.S. and Europe. Transcenta is developing a diverse pipeline of more than a dozen novel biologic therapies 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. For inquiries regarding capital cooperation opportunities, please contact us at ir@transcenta.com
Contacts:
PR@transcenta.com
IR@transcenta.com
BD@transcenta.com
