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Curocell Receives of MFDS Approval for 'Next-gen CD19 CAR-T'
by Sungmin Kim
Up to 100 Diffuse large B-cell lymphoma (DLBCL) patients will be enrolled in South Korea
Curocell, Inc., a clinical-stage biotech developing next-generation CAR-T (OVIS™) therapies, announced that the Ministry of Food and Drug Safety (MFDS) of Korea has approved its Phase 1/2 clinical study application for CRC01, CD19 CAR-T cell therapy in patients with relapsed/refractory diffuse large B-cell lymphoma(DLBCL). This study is expected to be initiated in the first half of 2021.
CRC01, recognized CD19 and is based on OVIS™, a first in class CAR-T platform co-developed with KAIST. OVIS™ downregulates PD1 and TIGIT in the same viral vector, designed to express a CAR protein, allowing cost-effective and simple manufacturing. Curocell holds the global development and commercial rights for CRC01 and OVIS™
Last year, Curocell established GMP facility with a size of 500 ㎡ is located inside the Research Institute for Future Medicine of Samsung Seoul Hospital, which is expected to cell therapies for an annual number of 100 patients.
"We are excited to receive Korea's first IND clearance for a CAR-T therapy," said Gunsoo Kim, CEO of Curocell. "OVIS™ is a unique CAR-T platform that combines CAR-T with immune checkpoint receptor inhibition. This unique technology can be a breakthrough for patients who are difficult to treat with conventional CD19 CAR-T."
