CARsgen Announces Positive Topline Results from China GC/GEJ Pivotal Phase II Clinical Trial of Claudin18.2 CAR-T (Satri-cel)

SHANGHAI, Dec. 30, 2024 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces the positive results from the pivotal Phase II clinical trial CT041-ST-01(NCT04581473). This study is an open-label, multicenter clinical trial evaluating the safety and efficacy of satricabtagene autoleucel ("satri-cel", CT041) (an autologous CAR T-cell product candidate against Claudin18.2) in subjects with Claudin18.2 expression-positive, advanced gastric/gastroesophageal junction cancers that have failed at least 2 prior lines therapy. Patients were 2:1 randomly assigned to receive treatment of satricabtagene autoleucel infusion or treatment of physician's choice (including paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab). The primary endpoint of the trial is progression-free survival (PFS) assessed by the Independent Review Committee (IRC). The study met its primary endpoint of a statistically significant improvement in PFS assessed by IRC for patients treated with satri-cel infusion as compared to treatment of physician's choice (paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab). Previous data demonstrates that the safety profile of satricabtagene autoleucel was manageable.

"We are thrilled to see that satri-cel has achieved positive results in the pivotal Phase II clinical trial in China. The study demonstrates that satri-cel provides significant benefits to gastric cancer patients who have failed at least two prior lines of therapy. This represents a groundbreaking milestone for the field of CAR-T therapies against solid tumors. We anticipate submitting an NDA to the NMPA in the first half of 2025 and look forward to satri-cel becoming the world's first CAR-T product for solid tumors, bringing hope to more patients as soon as possible. Additionally, we will continue to explore the potential of satri-cel in adjuvant therapy for gastric and pancreatic cancers, aiming to deliver even greater benefits to patients," said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics.

About Satri-cel

Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets 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 gastric/gastroesophageal junction cancer 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 U.S. FDA for the treatment of advanced GC/GEJ with Claudin18.2-positive tumors in January 2022. Satri-cel received Orphan Drug designation from the U.S. FDA in 2020 for the treatment of GC/GEJ.

About CARsgen Therapeutics Holdings Limited

CARsgen is a biopharmaceutical company with operations in China and the U.S., focusing on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. CARsgen has established a comprehensive CAR T-cell research and development platform that covers target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production. Internally, CARsgen has developed novel technologies and a product pipeline with global rights to address significant challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs. CARsgen's mission is to become a global biopharmaceutical leader that provides innovative and differentiated cell therapies for cancer patients worldwide and makes cancer curable.

Forward-looking Statements

All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, https://www.carsgen.com. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release.