The board of directors of CARsgen Therapeutics Holdings Limited announced that the final follow-up results of the investigator-initiated trial CT041-CG4006 (NCT03874897) of satricabtagene autoleucel (satri-cel, CT041) (an autologous CAR T-cell product candidate against Claudin18.2) have been published in Nature Medicine on June 3, 2024. Data were presented as an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting on June 3, 2024, 12:30 pm-3:30 pm, Eastern Daylight Time. Further details have been posted on the corporate website https://www.carsgen.com.

The article in Nature Medicine was titled Claudin18.2-specific CAR T Cells in gastrointestinal cancers: phase 1 trial final results. The 2024 ASCO Annual Meeting abstract was titled Claudin18.2-Targeted Chimeric Antigen Receptor T Cell Therapy for Patients with Gastrointestinal Cancers: Final Results of CT041- CG4006 Phase 1 Trial. Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that can potentially be the first-in-class globally.

Satri-cel has been developed for the treatment of Claudin18.2 positive solid tumors with a primary focus on gastric cancer/gastroesophageal junction cancer (GC/GEJ) and pancreatic cancer (PC). Ongoing trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced GC/GEJ in China (CT041- ST-01, NCT04581473), a Phase I clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). Satri-cel was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. FDA for the treatment of advanced GC/GEJ with Claudin18.2-positive tumors in January 2022 and was granted PRIME eligibility by the EMA for the treatment of advanced gastric cancer in November 2021.

Satri-cel received an Orphan Drug designation from the U.S. FDA in 2020 for the treatment of GC/GEJ and an Orphan Medicinal Product designation from the EMA in 2021 for the treatment of advanced gastric cancer.