AbClon has received regulatory approval to conduct phase 1 and 2 clinical trials of AT101, a CAR-T therapy with new antibodies, for blood cancer patients.
AT101 is a CAR-T immuno-oncology that targets the CD19 protein, and its application area is completely different from the existing global blockbuster CAR-T cell therapies for blood cancer.
The company developed the “1218 antibody” optimized for a new epitope through its novel epitope screening technology and applied it to AT101. Targeting a new epitope may show therapeutic efficacy for patients with existing blood cancer and those who do not respond to other CAR-T treatments, which could make AT101 a game-changer in the CAR-T therapy market in the future, according to AbClon.
AbClon plans to assess the safety, efficacy, and tolerability of AT101 in phase 1 and 2 trials with 100 patients.
The company, jointly with Asan Medical Center, will recruit participants with relapsed and refractory B-cell Non-Hodgkin's Lymphoma (NHL) in phase 1 clinical trials and determine the maximum tolerated dose and recommended dose for phase 2 clinical trials by analyzing safety and tolerability. In addition, the phase 2 study will evaluate the objective response rate of the drug.
Unlike existing anticancer drugs, CAR-T cell therapy is called a “miracle anticancer drug” because of its high reactivity and therapeutic effect, even showing a complete response of blood cancer with a single administration. However, only five therapies, including Kymriah, Yescarta, and Tecartus, have been approved worldwide, and only Kymriah is currently authorized in Korea.
The company confirmed that AT101 kills cancer cells in Kymriah-refractory or recurrent models through preclinical testing and expects the newly approved clinical studies to derive significant outcomes.
AbClon aims to start administering AT101 in phase 1 clinical trials in the first half of 2022 based on close cooperation with clinical hospitals.
"Based on these clinical trials, we plan to verify the high efficacy of AT101 and apply for conditional approval for domestic use through close consultation with related agencies,” an AbClon official said. "We will focus on clinical development to provide more affordable and effective treatment opportunities to patients fighting blood cancer."