AbBio Co.,Ltd. has entered into Letter of Commitment with Noile-Immune Biotech Inc. and National Cancer Center for the development and commercialization of FCAR-CD20 CAR-T and plans to broaden sCAR-T applications.
AbBio Co.,Ltd. (“AbBio”) announces that it has entered into a Letter of Commitment (“LoC”) with Noile-Immune Biotech Inc.(Minato-ku, Tokyo, Japan; “Noile-Immune”) and National Cancer Center (Chuo-ku, Tokyo, Japan; “NCC”) to pursue the development and commercialization of FCAR-CD20 CAR-T cell therapy by leveraging the Phase I clinical data generated by NCC.
The National Cancer Center Hospital East (“NCCHE”) has confirmed the safety and efficacy of FCAR-CD20 CAR-T cell therapy in a Phase I clinical trial targeting patients with refractory CD20-positive B-cell non-Hodgkin lymphoma, with the results presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, USA. Notably, the therapy demonstrated outstanding clinical outcomes compared to existing CAR-T treatments, achieving a 100% overall response rate (ORR), with 67% complete response (CR) and 33% partial response (PR), alongside long-term remission in patients with relapsed/refractory B-NHL. Moreover, no cases of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) were observed, highlighting the therapy’s potential to overcome key limitations of conventional CAR-T approaches.
Through the LoC, AbBio and Noile-Immune have secured global exclusive rights to the comprehensive information (“Information”) from the Phase I trial conducted by NCCHE. Building on this foundation, AbBio plans to initiate subsequent clinical trials with the objective of advancing FCAR-CD20 CAR-T therapy toward commercialization.
Furthermore, AbBio plans to broaden the application of its FCAR-T cell technology platform (“sCAR-T”) - which comprises a switch molecule and a CAR-T engineered to specifically recognize the switch molecule, and offers the ability to modulate therapeutic activity through switch molecule dosing, manage on-target off-tumor effects, and potentially target diverse tumor antigens by employing different switch molecules - by targeting a variety of tumor antigens in solid tumors.
[ AbBio Co.,Ltd.]
AbBio Co., Ltd., a South Korea-based biotechnology company, is actively advancing its sCAR-T platform – an adoptive cellular immunotherapy that integrates a switch molecule with a CAR-T engineered for precise and controllable targeting. Preclinical studies have confirmed the safety and antitumor efficacy of the platform supported by a well-understood mechanism of action. AbBio is committed to expanding the therapeutic potential of sCAR-T by developing additional pipeline candidates through collaborations with leading global biotech partners, with the goal of delivering innovative and safe treatment options for patients affected by cancer and autoimmune diseases.
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