Appclon Reports Complete Remission in All Patients of Mid-Dose Group in Phase 1 CAR-T Clinical Trial

Appclon disclosed partial clinical results showing that complete remission was observed in all patients in the mid-dose group during the Phase 1 clinical trial of 'AT101,' a chimeric antigen receptor (CAR)-T therapy under development.

Appclon announced on the 18th that it revealed some of the nonclinical and Phase 1 clinical results of AT101 at the American Association for Cancer Research (AACR) held from the 14th to 19th (local time) in the United States.

In the Phase 1 clinical trial of AT101, Appclon disclosed the therapeutic effects for two groups among three dose groups: low dose and mid dose. The mid-dose group, despite being a lower dose range compared to global CAR-T therapies 'Kymriah' and 'Yescarta,' administered AT101 to three patients, and complete remission was confirmed in all patients at the first examination after four weeks.

An Appclon official stated, "Upon confirming the complete remission results in all patients of the mid-dose group, both the clinical and development teams are excited with expectations for the birth of a new CAR-T drug," emphasizing, "Even at a dose range five times lower, complete remission was confirmed in three out of six patients, and partial remission in two, demonstrating superior efficacy compared to existing CAR-T therapies."

Side effects commonly associated with CAR-T therapies, cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), were observed at low rates of 11.1% and 22.2%, respectively. The incidence of grade 3 or higher adverse events was 11.1%, indicating encouraging safety data. Appclon is also reviewing clinical results for the high-dose group. These data, including the high-dose results, are expected to be disclosed at the American Society of Clinical Oncology (ASCO) meeting scheduled for June.

This Phase 1 trial selected patients with various hematologic cancers, including relapsed or refractory diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL), which are difficult to treat with existing anticancer drugs, thereby confirming the potential for expanded indications. The study involves Professor Marco Ruella's team from the University of Pennsylvania School of Medicine, Professor Junho Jung's team from Seoul National University College of Medicine, Professor Deokhyun Yoon's CAR-T Center team at Asan Medical Center, and Ulsan University Hospital.

Meanwhile, the nonclinical results presented together included data on the superiority and differentiation of AT101 in treating hematologic cancers compared to existing CAR-T therapies. By using Appclon's independently developed h1218 antibody in AT101, there is potential for higher anticancer efficacy than existing commercial CAR-T products that use the FMC63 antibody. Notably, AT101 was confirmed to be effective against CD19 mutant cells reported in patients who relapsed after conventional CAR-T therapy.

Appclon holds proprietary intellectual property rights for the technology applied to AT101 and is building business potential through a global patent expansion strategy. Patents have been registered in South Korea, the United States, Japan, and Canada, with examinations underway in Europe and China.

An Appclon official said, “AT101 currently shows superior anticancer effects along with safety compared to global CD-19 CAR-T products,” adding, “We will establish a turning point for domestic and international commercialization based on the clinical results of AT101.”

This content was produced with the assistance of AI translation services.