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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PackGene is a CRO & CDMO technology company that specializes in packaging recombinant adeno-associated virus (rAAV) vectors. Since its establishment in 2014, PackGene has been a leader in the AAV vector CRO service field, providing tens of thousands of custom batches of AAV samples to customers in over 20 countries. PackGene offers a one-stop CMC solution for the early development, pre-clinical development, clinical trials, and drug approval of rAAV vector drugs for cell and gene therapy (CGT) companies that is fast, cost-effective, high-quality, and scalable. Additionally, the company provides compliant services for the GMP-scale production of AAVs and plasmids for pharmaceutical companies, utilizing five technology platforms, including the π-Alpha™ 293 cell AAV high-yield platform and the π-Omega™ plasmid high-yield platform. PackGene’s mission is to make gene therapy affordable and accelerate the launch of innovative gene drugs. The company aims to simplify the challenging aspects of gene therapy development and industrialization processes and provide stable, efficient, and economical rAAV Fast Services to accelerate gene and cell therapy development efforts from discovery phase to commercialization.

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