GC LabCell's Next-Generation NK Cell Therapy AB101 Approved for Phase 1/2 Clinical Trials in the U.S.
[Asia Economy, reporter Jo Hyunui] GC LabCell announced on December 8, 2020, that its U.S. subsidiary, Artiva Biotherapeutics, has received approval from the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application to conduct Phase 1/2 clinical trials of the natural killer (NK) cell therapy 'AB101'.
This clinical trial will assess the safety and efficacy of AB101 in patients with relapsed or refractory lymphoma who have previously been treated with existing therapies. The trial will be conducted at 20 cancer centers in the United States.
AB101 is a next-generation NK cell therapy derived from umbilical cord blood, designed for the treatment of lymphoma and intended to be used in combination with antibody therapies. In previous animal studies, AB101 demonstrated improved anti-cancer effects, such as enhanced survival rates and tumor suppression, compared to existing therapies.
This clinical trial marks the first collaborative project between GC LabCell and Artiva. Artiva was established last year in San Diego, United States, by GC Holdings and GC LabCell. The company is working toward commercialization by combining mass production technology based on AB101 with GC LabCell's NK cell therapy pipeline technology.
Starting with AB101, Artiva plans to initiate U.S. clinical trials of the AB200 series, which is also based on GC LabCell's technology, beginning next year. To support this, Artiva secured $78 million (approximately 84.6 billion KRW) in investment in June this year.
GC LabCell will receive milestone-based technology fees for each stage of development achieved with the NK cell therapy technology being developed in the United States.
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Hwang Youkyung, head of GC LabCell's Cell Therapy Research Institute, stated, "Through our collaboration with Artiva, AB101 has successfully entered clinical trials as originally planned. We hope that the efficacy of GC LabCell's NK cell therapy, which has already been demonstrated in various preliminary clinical studies in Korea, will also be confirmed through these U.S. clinical trials."
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