Abclon Signs Agreement with National New Drug Development Project Group for AT101 Phase 2 Clinical Trial

Appclon announced on the 17th that it has signed a business agreement with the National New Drug Development Project Group (Director Park Young-min, hereinafter referred to as the Project Group) for the Phase 2 clinical trial of ‘AT101’. Based on the results of this Phase 2 trial, the company plans to accelerate the approval process for product authorization from the Ministry of Food and Drug Safety (MFDS).

AT101 is a novel CAR-T (Chimeric Antigen Receptor T-cell) drug targeting diffuse large B-cell lymphoma (DLBCL). It will undergo a Phase 2 clinical trial over the next two years as the first task of this year’s National New Drug Development Project.

The primary objective of the task is to evaluate the objective response rate, while secondary objectives include assessing tolerability, efficacy, and pharmacokinetic characteristics. AT101 has previously received support from the National New Drug Development Project during its Phase 1 clinical trial, and based on the safety confirmed in Phase 1, the Phase 2 trial is currently underway at seven hospitals in South Korea.

Compared to existing CAR-T therapies targeting CD19, AT101 has demonstrated a higher initial response rate and follow-up data, proving its superiority in terms of efficacy and durability over global CAR-T therapies.

The mechanism of action difference, applying the h1218 antibody to the CAR-T construct, and the resulting superior efficacy compared to existing treatments were also published in the prestigious international journal Molecular Cancer. The company explained that the high efficacy confirmed in Phase 1 has raised expectations for Phase 2.

An Appclon representative stated, “Separately, we have secured treatment results for patients who are refractory or relapsed to existing CAR-T therapies to maximize the potential of this global new drug,” adding, “We will also strive for early product approval from the MFDS based on the clinical results.”

Meanwhile, AT101 reported complete remission (CR) in all patients receiving intermediate and high doses during Phase 1. The low-dose group consisted of six subjects, accounting for half of the total results. Despite including patients who received a very small amount?about 4%, or one twenty-fifth, of the Phase 2 dose?the trial achieved excellent outcomes with an overall survival (OS) rate of 82.5% and a progression-free survival (PFS) rate of 66.7%.