GC Cell Begins Phase 3 Clinical Trial of Immuncell-LC for Pancreatic Cancer

[Asia Economy, Reporter Yoo Hyunseok] GC Cell, a company specializing in cell therapy, announced on September 7, 2021, that the first patient has been enrolled in the Phase 3 clinical trial of Immuncell-LC for pancreatic cancer.

According to the clinical trial plan (IND) approved by the Ministry of Food and Drug Safety in December 2020, a commercial Phase 3 clinical trial aimed at adding a new indication will be conducted at clinical sites such as Seoul National University Hospital, targeting 408 patients with pancreatic cancer.

Pancreatic cancer has a five-year survival rate of 12.6%, the lowest among the top ten cancers. Since 1993, when statistics began to be compiled, the five-year survival rate for all cancers has increased by 27.4%, while for pancreatic cancer, it has only increased by 2.0%, making it a particularly difficult-to-treat disease.

The trial will evaluate efficacy and safety by dividing patients with pancreatic ductal adenocarcinoma who have undergone curative resection into two groups: one receiving standard treatment with gemcitabine alone, and the other receiving combination therapy with Immuncell-LC and gemcitabine. The combination therapy group will receive 16 additional doses of Immuncell-LC along with standard gemcitabine treatment.

The primary endpoints include recurrence-free survival (RFS), overall survival (OS), and changes in tumor marker CA19-9 levels through the combination treatment of gemcitabine and Immuncell-LC.

Lee Sanghyeop, Professor of Gastroenterology (Pancreatobiliary Cancer Center) at Seoul National University Hospital and the principal investigator (PI) of the clinical trial, stated, "This clinical study is a promising new drug candidate," adding, "In particular, combining it with postoperative chemotherapy is expected to maximize anticancer effects and improve the survival rate of pancreatic cancer, a notoriously difficult-to-treat disease."

Immuncell-LC was already approved as an anticancer agent for liver cancer in 2007. Last month, it was approved as an advanced biopharmaceutical under the Advanced Regenerative Bio Act.

Lee Deukjoo, CEO of GC Cell, said, "Developing a treatment for pancreatic cancer is a challenging field where even multinational pharmaceutical companies have faced many failures. However, the investigator-initiated trial (IIT) published in 2014 for patients with terminal pancreatic cancer showed sufficient potential, so we expect good results from this Phase 3 clinical trial for pancreatic cancer." He added, "In the global market, the pancreatic cancer field is highly competitive in terms of patient numbers, country distribution, and competing drugs. Therefore, this domestic Phase 3 clinical trial will provide important data for entering the global market."

GC Cell recently filed a PCT international application for the manufacturing method of Immuncell-LC in three countries and is currently in discussions with multiple partners for technology transfer. In addition, the company has completed PCT international applications in four countries for its mesothelin-targeted solid tumor CAR-T therapy currently under development, accelerating its global market entry strategy.