Curocell, a Kosdaq-listed biotech company, said it received the topline data from its phase 2 clinical trial for its CAR-T (chimeric antigen receptor-T) therapy, Anbal-cel,  to treat diffuse large B-cell lymphoma (DLBCL).

The study is Korea's first clinical trial of a CAR-T therapy, involving 79 adult participants aged between 22 and 85 years, conducted across six institutions including Samsung Medical Center, from March 2022 to Oct. 2023.

The trial was an open-label, multicenter, single-group study assessing the safety and efficacy of a single administration of Anbal-cel in patients who had relapsed or were refractory to two or more lines of treatment for DLBCL.

The analysis of the phase 2 clinical trial topline data revealed a complete response rate (CRR) of 67.1 percent among 73 participants, indicating that Anbal-cel completely eradicated cancer cells in these patients.

The company stressed that this CRR is the highest recorded when compared to existing CAR-T therapies in the global market. Additionally, the objective response rate (ORR), a primary evaluation metric indicating the proportion of patients who showed a response to the drug, was 75.3 percent.

Following these promising results, Curocell plans to apply for domestic drug approval in the latter half of this year. If Anbal-cel obtains drug approval, Korea will become the fourth country to develop its CAR-T therapy, following the U.S., China, and India.

The company has already set up the largest CAR-T therapy-dedicated commercial good manufacturing practice (GMP) facility in Korea on a global scale, with a size of 16,360 square meters. With this capacity, the company intends to commence domestic production and supply upon receiving drug approval.

"We are very pleased to have successfully completed the clinical trial after three years of hard work and would like to thank everyone involved," Curocell CEO Kim Gun-soo said. "The final results confirm the high competitiveness of Anbal-cel, and we will do our best to expedite the approval and launch of the drug."