GC Cell Confirms Efficacy of Pancreatic Cancer CAR-T Therapy in Animal Trials

MSLN-Targeted CAR-T Achieves 100% Tumor Eradication in Orthotopic Models
Dual Strategy for U.S. Entry: Immunecell-LC and Solid Tumor CAR-T
NOVACEL Inc. Established for Expansion into North and South America and Europe

[Asia Economy, Reporter Park Hyungsoo] GC Cell, a developer of cell therapy products, revealed its strategy for entering the U.S. market and shared progress on its CAR-T therapy development during an online corporate presentation.

On March 12, starting at 4 p.m., GC Cell held a live corporate presentation and announced, "The animal test results for our CAR-T therapy (MSLN-CAR-T) targeting solid tumors have been promising."

The CAR-T therapy currently under development by GC Cell specifically targets mesothelin (Mesothelin) and is designed for solid tumors.

In an orthotopic pancreatic cancer mouse model, where cancer was transplanted into the pancreas, MSLN-CAR-T cells were administered both intraperitoneally and intravenously. While all mice in the control group experienced tumor growth, those that received the first dose of MSLN-CAR-T cells showed an 80-90% anti-tumor effect. After the second dose, pancreatic cancer cells were completely eradicated, achieving complete remission (CR).

In an orthotopic pancreatic cancer mouse model that does not express mesothelin, even two administrations of MSLN-CAR-T cells resulted in tumor growth similar to the negative control group. This demonstrates that MSLN-CAR-T cells specifically respond only to mesothelin and exhibit anti-tumor effects against pancreatic cancer. MSLN-CAR-T cells have addressed the issue of antigen specificity-one of the main reasons for CAR-T therapy failures in solid tumors-by targeting only mesothelin and achieving complete remission. Even after 12 weeks of ongoing experiments, 100% anti-tumor activity has been maintained.

GC Cell plans to conduct a Phase 1 clinical trial of its CAR-T therapy in the United States in the second half of next year. Currently, two CAR-T therapies for hematologic cancers are available in the U.S., but there have been limited achievements in the solid tumor field. GC Cell believes that MSLN-CAR-T is highly competitive for direct entry into the U.S. market.

To facilitate its U.S. expansion, GC Cell established its U.S. subsidiary, NOVACEL Inc., in California earlier this year. The company is considering technology exports or licensing agreements through partners that can facilitate entry into the North American, South American, and European markets.

Immunecell-LC, which is currently marketed in Korea, is also preparing to enter the U.S. market. By utilizing Phase 3 clinical trial data from Korea and safety data accumulated from over 5,000 patients treated over the past decade, the company aims to minimize FDA approval risks.

In 2018, Immunecell-LC received Orphan Drug Designation (ODD) from the FDA for liver cancer, pancreatic cancer, and glioblastoma. With support from the U.S. government, the company plans to target niche markets where no treatments currently exist.

Immunecell-LC obtained product approval from the Ministry of Food and Drug Safety in 2007. Since 2014, when clinical trial results began to be published, sales have surged, reaching annual sales of 34.2 billion KRW last year.

Lee Deukjoo, CEO of GC Cell, stated, "GC Cell will enter the U.S. market with a dual strategy, leveraging both Immunecell-LC and MSLN-CAR-T," adding, "We aim to raise the profile of K-Bio and become a leading global comprehensive immuno-oncology company."

This content was produced with the assistance of AI translation services.