Moderna and China’s CARsgen Therapeutics have joined forces to merge their expertise in the cancer treatment arena. The collaboration seeks to test the combined efficacy of Moderna’s experimental Claudin18.2 mRNA cancer vaccine and CARsgen’s Claudin18.2 CAR T cell therapy, specifically the CT041 candidate. The partnership will oversee both preclinical and Phase I evaluations.

Lin Guey, Moderna’s Chief of External Research, spotlighted the potential of Claudin18.2, identifying it as a viable therapeutic target for multiple cancer types that currently lack sufficient medical treatments. The joint venture with CARsgen will delve into the synergy between CAR-T therapies and mRNA cancer vaccines that focus on the Claudin18.2 protein.

Delving deeper into the science, Claudin18.2, derived from Claudin18, stands out due to its distinctive expression pattern. While its presence in regular tissues is sparse, it appears abnormally in many malignant tumors. This uniqueness makes it an ideal target for cancer therapies, especially those linked to the stomach.

CARsgen’s CT041 has already caught the FDA’s attention. In January 2022, it earned the Regenerative Medicine Advanced Therapy (RMAT) Designation, positioning it as a therapeutic solution for advanced gastric cancer and gastroesophageal junction cancer with Claudin18.2-positive tumors. Furthermore, in October 2020, the FDA recognized CT041 with an Orphan Drug designation for similar treatments.
Progressing on its potential, CARsgen, in May 2023, began recruiting patients for a U.S.-based Phase II trial of CT041, targeting those suffering from Claudin18.2-positive advanced gastric and gastroesophageal junction cancers. These patients had experienced unsuccessful outcomes from at least two prior systemic treatments.

CARsgen’s leadership, embodied by CEO and CSO Zonghai Li, holds CT041 in high esteem, referring to it as the foremost solid tumor CAR-T therapy currently in development. He reiterated its promising capabilities in addressing gastric and pancreatic cancers. Li envisions a future where combining CAR T-cell treatments with cancer vaccines amplifies the clinical benefits for patients. He also acknowledged Moderna’s pioneering efforts in the realm of mRNA-based medical solutions.

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