SHANGHAI , Aug. 19, 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 that the completion of enrollment in the pivotal Phase II clinical trial of satricabtagene autoleucel ("satri-cel", R&D code: CT041, an autologous CAR-T product candidate against Claudin18.2) in accordance with the clinical protocol, for advanced gastric/gastroesophageal junction cancers (GC/GEJ) in China.

This study is an open-label, multicenter, randomized clinical trial in China evaluating the efficacy and safety of satri-cel in subjects with Claudin18.2-positive advanced GC/GEJ patients who have failed at least two prior lines of therapy. Treatment for the control group is physician's choice (paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab).

Gastric cancer is one of the most common malignant tumors in China, with an incidence of approximately 359,000 incident cases and a mortality of approximately 260,000 deaths in 2022^[1]. Patients with advanced gastric cancer often face limited treatment options and poor prognosis. There is a strong need for more innovative and efficacious therapies. Satri-cel is an autologous CAR T-cell product candidate against Claudin18.2 that has the potential to be first-in-class globally. It primarily targets GC/GEJ and pancreatic cancer (PC). The published clinical data on satri-cel have shown promising safety and efficacy.

The final results of the investigator-initiated Phase I clinical trial CT041-CG4006 (NCT03874897) were published in Nature Medicine and orally presented at the 2024 ASCO annual meeting. There were no dose-limiting toxicities (DLTs), no Grade 3 or higher cytokine release syndrome (CRS), or immune effector cell-associated neurotoxicity syndrome (ICANS) observed. In 51 patients with GC/GEJ with target lesions at baseline who received satri-cel monotherapy, the overall response rate (ORR) was 54.9% (28/51), the disease control rate (DCR) was 96.1% (49/51), and the median duration of response (mDOR) was 6.4 months.^[2][3] The phase Ib results from CT041-ST-01 (NCT04581473) clinical trial presented at the 2022 ASCO annual meeting, further showed the manageable safety and promising efficacy of satri-cel. Among 14 GC/GEJ patients who had received at least 2 prior lines of treatment and received satri-cel monotherapy, there were no DLTs or AEs leading to death. No ICANS or gastrointestinal mucosal injury were reported. The ORR and DCR were 57.1% and 78.6% respectively.^[4]

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "We are very pleased to announce the successful completion of patient enrollment in the pivotal Phase II clinical trial of satri-cel in China. This significant milestone marks another solid step forward in our development of CAR T-cell therapies for solid tumors. We extend our gratitude to all the investigators, the patients and their families for their trust and support. We look forward to the submission of New Drug Application and the approval in China, to benefit patients with gastric cancer. As one of the leading companies in the field of CAR T-cell therapies, we remain committed to addressing the major challenges faced by existing CAR T-cell therapies and will develop more innovative CAR-T products for cancer patients."

About Satri-cel

Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be first-in-class globally. Satri-cel targets 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 Claudin18.2-positive advanced GC/GEJ cancers in January 2022 and 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.

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.

References

[1] Han B, et al. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53. doi: 10.1016/j.jncc.2024.01.006
[2] Qi C, et al. Claudin18.2-specific CAR T cells in gastrointestinal cancers: phase 1 trial final results. Nat Med. 2024 Jun 3. doi: 10.1038/s41591-024-03037-z
[3] Qi C, et al. 2024 ASCO Abstract #2501
[4] Qi C, et al. 2022 ASCO Abstract #4017

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