Appclon "Overwhelming Cure Effect Maintained Compared to Existing CAR-T"... Results Presented at ASCO

Appclon announced on the 4th that it presented follow-up data from the Phase 1 clinical trial of the chimeric antigen receptor T-cell (CAR-T) therapy ‘AT101’ for hematologic cancers at the American Society of Clinical Oncology (ASCO).

This study confirmed the therapeutic effects in patients for about two years after the Phase 1 administration. In the evaluation with a median follow-up period of 16.4 months, AT101 demonstrated superior therapeutic efficacy compared to existing CAR-T therapies. Among the 9 subjects who showed complete remission in the Phase 1 evaluation, 7 maintained complete remission for more than 12 months, with a long-term complete remission rate reaching 77.8%.

There were 6 subjects in the low-dose cohort of the AT101 Phase 1 trial, accounting for half of the overall results. Despite including patients who received a very small dose corresponding to 4% of the Phase 2 dose, the results showed an overall survival (OS) rate of 82.5% and a progression-free survival (PFS) rate of 66.7%.

According to published papers on the Phase 2 clinical trial results of Yescarta and Kymriah, the overall survival rates at 12 months were 59% and 49%, respectively. Notably, Yescarta’s 15-month progression-free survival rate was reported as 41%. Although it is difficult to directly compare AT101’s Phase 1 results with global Phase 2 clinical trial outcomes, the company explained that the results are overwhelmingly superior to existing CAR-T therapies.

The strong anticancer activity of AT101, due to its continuous cancer cell-killing ability and long-lasting drug efficacy, has been reported multiple times in international academic journals and conferences. This research was conducted in collaboration with the University of Pennsylvania School of Medicine, Seoul National University College of Medicine, and others. As a result of applying Appclon’s CAR-T therapy technology, AT101, which uses Appclon’s humanized antibody ‘h1218,’ showed a higher complete remission rate (CR) of 75% and an objective response rate (ORR) of 91.7% compared to existing CAR-T therapies. Among the 6 subjects in the intermediate- and high-dose cohorts of the Phase 1 trial, 100% showed complete remission.

An Appclon representative stated, "Based on the efficacy and safety of AT101 secured in Phase 1, we are currently conducting Phase 2 clinical trials," and added, "We believe that the sustained therapeutic effect of AT101 will enable complete treatment and overcoming of hematologic cancer patients’ diseases."

They continued, "We are also striving to secure therapeutic effects for patients who are refractory to existing CAR-T therapies," emphasizing, "AT101 is increasing the possibility of opening a new global market for hematologic cancer treatments."