ProBio and Curocell Achieve Key CAR-T Milestone with BLA Regulatory Approval and Commercial Readiness

ProBio Inc. and Curocell have achieved a significant milestone with the regulatory approval and commercial readiness of Anbalcabtagene autoleucel (Anbal-cel; code: CRC01), a next-generation CD19-targeted CAR-T cell therapy developed for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This approval highlights Korea's growing innovation in advanced therapies and marks a critical step toward bringing transformative treatment options to patients, according to ProBio Inc.

Data from Phase 1/2 studies indicated strong efficacy, with an overall response rate (ORR) of 82% and a complete response (CR) rate of 82% in patients with relapsed or refractory DLBCL. The therapy also demonstrated a manageable safety profile, where the most frequently reported grade 3/4 adverse events included neutropenia, anemia, and thrombocytopenia.

A distinguishing feature of CRC01 is Curocell's proprietary OVIS™ platform, which suppresses the expression of immune checkpoint receptors PD-1 and TIGIT in CAR-T cells. This mechanism aims to counteract immune suppression within the tumor microenvironment, potentially enhancing therapeutic efficacy compared to traditional CAR-T approaches.

ProBio has supported Curocell from the post-IND supplier change to BLA application and commercial production. The partnership involved managing complex change control activities to achieve rapid regulatory approval for significant process and site changes. ProBio's expertise in lentiviral vector manufacturing allowed for process characterization completion within four months and achieving first-pass success across all validation batches. This led to the successful attainment of MFDS GMP certification, the first of its kind for a lentiviral vector manufacturing facility in Korea.

The program has now moved into the commercial manufacturing phase. Allen Guo, CEO of ProBio, expressed enthusiasm for the achievement, stating that the approval of Anbal-cel represents a significant advancement for patients in Korea and highlights the global potential of CAR-T therapies. Kim Gun-soo, CEO of Curocell, emphasized the importance of the approval as Korea's first CAR-T therapy and acknowledged ProBio's critical role in navigating the entire process from clinical development to commercialization.