CARsgen Therapeutics and Moderna have signed a collaboration agreement to evaluate the former’s investigational Claudin18.2 CAR T-cell product candidate (CT041) in combination with the latter’s investigational Claudin18.2 mRNA cancer vaccine.

CT041 (satricabtagene autoleucel) is an investigational autologous CAR T-cell product candidate against the protein Claudin18.2.

The partnership intends to test CT041 in combination with Claudin18.2 mRNA cancer vaccine through preclinical research and a phase 1 clinical trial.

CARsgen Therapeutics founder, CEO and board chairman Zonghai Li said: “CT041 is the most advanced solid tumour CAR-T in development (pivotal phase 2) and continues to show promise in treating gastric and pancreatic cancers.

“In our quest to make cancer curable, we are continuously exploring multiple modalities to eradicate tumours. Attacking tumours with CAR T-cell therapy in combination with a cancer vaccine could potentially provide greater clinical benefit to patients.

“Moderna has clearly established themselves as a scientific and commercial leader in the field of mRNA-based vaccines and therapeutics, and we are pleased to partner with Moderna to explore a potential synergism between our innovative therapies.”

CARsgen, a Chinese biotechnology company developing CAR T-cell therapies for hematologic malignancies and solid tumours, is evaluating CT041 for the potential treatment of gastric, pancreatic, and other specified digestive system cancers.

It is currently in several ongoing clinical trials in North America and China.

The American biotechnology company is developing an investigational off-the-shelf mRNA cancer vaccine that encodes for the Claudin18.2 protein, a tumour-related antigen.

Moderna External Research Ventures chief scientific officer Lin Guey said: “We are pleased to partner with CARsgen to explore the potential synergy of CAR-T with an investigational mRNA cancer vaccine that encodes for the Claudin18.2 protein.

“Claudin18.2 is a promising therapeutic target to potentially treat multiple cancer types with high unmet medical needs. We continue to deliver on the promise of mRNA science to create a new generation of transformative medicines in oncology.”

CT041 received Orphan Drug designation from the US Food and Drug Administration (FDA) in 2020 for Gastric Cancer/ gastroesophageal junction and Orphan Medicinal Product designation from the European Medicines Agency in 2021 to treat advanced gastric cancer.