AbClon announced on the 11th that the unique mechanism of action and Phase 1 clinical trial results of AT101, its novel CAR-T therapy, have been published in Molecular Cancer (Impact Factor: 37), one of the prestigious journal in oncology.

Molecular Cancer ranks among the top 1% of cancer research journals worldwide. The corresponding authors of the study include Professor Marco Ruella from the Center for Cellular Immunotherapies at the University of Pennsylvania, Professor Dok Hyun Yoon, Director of the CAR-T Center at Asan Medical Center, Professor Junho Chung of the Cancer Research Institute at Seoul National University College of Medicine, and Dr. Jong-Seo Lee, CEO of AbClon.

The published study highlights three distinct features of AT101, a novel CAR-T therapy independently developed by AbClon, along with its unique efficacy demonstrated in Phase 1 clinical trial.

First, AT101 maximizes the cancer cell killing effect by binding more closely to the patient’s cancer cells than conventional CAR-T therapies. Second, it responds more quickly to cancer cells with a quick "hit and run" mechanism, enabling continuous attacks without exhaustion. This sustained cancer cell killing reaction allows AT101 to maintain a prolonged and potent anti-cancer effect in the patient's body, distinguishing it from existing CAR-T therapies. Third, AT101 uses a humanized antibody instead of a murine-derived one, extending the lifespan of CAR-T cells and enhancing therapeutic durability.

Due to these characteristics, AT101 demonstrated remarkable clinical outcomes in the Phase 1 trial conducted on blood cancer patients. Among the mid- and high-dose cohorts, all six patients achieved complete remission (CR). At the time of publication, patients had maintained their remission for a period ranging from six to 18 months without any relapse. This is a stark difference from conventional CAR-T therapies, where nearly half of the patients experience relapse within six months post-treatment.

Beyond its potency and durability, the study also highlights AT101’s effectiveness against patient-derived models resistant to CAR-T therapies using the FMC63 antibody, which is utilized in Novartis' Kymriah and Gilead’s Yescarta. Unlike these therapies, which failed to show any initial efficacy in certain resistant patient-derived models, AT101 successfully demonstrated therapeutic effects.

The findings on AT101 have also been covered by leading international media outlets and featured as a major news update on the University of Pennsylvania’s official website. According to the report, Professor Marco Ruella commented, "AT101 has the potential to address blood cancer patient populations that existing CAR-T therapies have failed to treat."

An AbClon representative stated, “The publication of this study confirms the outstanding therapeutic potential of AT101 in blood cancers. It also serves as an opportunity to showcase AT101 and AbClon to the global medical and biotech industries. With exclusive patent rights that do not infringe on existing CAR-T therapy patents, we are now more confident in driving AT101’s global expansion."

Professor Dok Hyun Yoon of Asan Medical Center, who participated as a co-corresponding author, remarked, "AT101 is a novel CD19 CAR-T therapy optimized for antigen binding using a humanized antibody. Its distinctive properties, validated through experimental studies and a Phase 1 clinical trial, provide strong evidence of its safety and therapeutic potential."

Professor Junho Chung of Seoul National University College of Medicine, who also participated as a co-corresponding author, added, "Developing antibodies for CAR-T therapies requires advanced technical expertise. Until now, all approved CD19 CAR-T therapies have utilized the same murine-derived antibody. However, AbClon has developed a CAR-T therapy using a novel humanized antibody. This achievement highlights AbClon’s outstanding technological capabilities and raises expectations for the development of its next-generation CAR-T therapies."