CARsgen Therapeutics has announced the publication of final follow-up results from the investigator-initiated Phase 1 trial (CT041-CG4006) of satricabtagene autoleucel (satri-cel) in Nature Medicine. The data was simultaneously presented as an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting on June 3.
Satri-cel is an autologous CAR T-cell therapy targeting Claudin18.2, a protein expressed in certain gastrointestinal cancers. The therapy has shown particular promise in patients with gastric cancer and gastroesophageal junction cancer.
Promising Clinical Results
Professor Lin Shen of Beijing Cancer Hospital, the study's principal investigator, highlighted the significance of the findings: "Satri-cel has shown promising efficacy and manageable safety profiles in patients with Claudin18.2-positive advanced gastrointestinal cancers, particularly those with gastric cancer or gastroesophageal junction cancer."
The Phase 1 trial results mark a notable advancement in applying CAR T-cell therapy to solid tumors, an area that has historically presented significant challenges compared to the success seen in hematological malignancies.
"This study marks a significant advancement in the field of CAR T-cell therapy for solid tumors," Professor Shen added. "It suggests that CAR T-cell therapy has the potential to transform existing treatment paradigms and provides important reference points for further innovative research."
Regulatory Recognition and Development Pipeline
Satri-cel has received multiple regulatory designations that could accelerate its path to market. The U.S. FDA granted it Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of advanced gastric/gastroesophageal junction cancer with Claudin18.2-positive tumors in January 2022. The European Medicines Agency (EMA) granted PRIME eligibility for advanced gastric cancer in November 2021.
Additionally, the therapy has received Orphan Drug designation from the FDA in 2020 and Orphan Medicinal Product designation from the EMA in 2021 for gastric cancer indications.
CARsgen is advancing satri-cel through multiple clinical trials globally:
- A confirmatory Phase II clinical trial for advanced gastric/gastroesophageal junction cancer in China (CT041-ST-01)
- A Phase I clinical trial for pancreatic cancer adjuvant therapy in China (CT041-ST-05)
- A Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02)
Expanding the Reach of CAR T-cell Therapy
Dr. Zonghai Li, Founder, Chairman, CEO, and Chief Scientific Officer of CARsgen Therapeutics, emphasized the importance of these developments: "This study represents a significant milestone in the field of CAR T-cell therapy for solid tumors, demonstrating the encouraging safety and efficacy of satri-cel."
The company aims to position satri-cel as the first-in-class CAR T-cell therapy globally for Claudin18.2-positive solid tumors, with a primary focus on gastric cancer/gastroesophageal junction cancer and pancreatic cancer.
Addressing Unmet Medical Needs
Gastrointestinal cancers, particularly gastric and pancreatic cancers, represent significant unmet medical needs globally. These cancers often have poor prognoses and limited treatment options, especially in advanced stages.
The development of satri-cel could potentially offer new hope for patients with these difficult-to-treat malignancies. CARsgen has expressed commitment to advancing the global clinical development of satri-cel to benefit more patients with gastric, pancreatic, and other gastrointestinal cancers.
About CARsgen Therapeutics
CARsgen is a biopharmaceutical company operating in China and the U.S., focused on developing innovative CAR T-cell therapies for both hematologic malignancies and solid tumors. The company has built a comprehensive research and development platform that spans target discovery, CAR T-cell development, clinical trials, and commercial-scale production.
The company has developed proprietary technologies to address major challenges in CAR T-cell therapy, including improving safety profiles, enhancing efficacy in solid tumors, and reducing treatment costs. CARsgen's stated mission is to "become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable."
