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DAEJEON, South Korea, Feb. 22, 2021 /PRNewswire/ --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. "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." About CRC01 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. About Curocell Curocell, based in Daejeon, South Korea, is clinical-stage biotech innovating CAR-T therapies. Curocell is developing OVIS CAR-T therapies with the goal of reducing non-responding patients who receive CAR-T therapy. Curocell established a GMP facility in Samsung Medical Center, one of the largest cancer centers in Asia with 655 beds. For more information, visitcurocellbtx.com/en. SOURCE Curocell, Inc.

Answer: Curocell announces Korean FDA clearance of the IND for CRC01, a first in kind immune checkpoint receptors downregulated CD19 CAR-T therapy