GC Cells said it has simultaneously filed a phase I IND for AB-201, an allogeneic chimeric antigen receptor-natural killer (CAR-NK) cell therapy targeting solid tumors, with the Ministry of Food and Drug Safety and the Australian Human Research Ethics Committee (HREC).

The trial is the first human clinical trial for allogeneic CAR-NK cell therapy using other people's cells among Korean companies.

AB-201 is an off-the-shelf (OTS), cryopreserved, allogeneic CAR-NK cell therapy consisting of cord blood-derived NK cells loaded with a CAR that targets human epithelial growth factor receptor type 2 (HER2), which is overexpressed in breast, ovarian, and gastric cancers.

Through GC Cell's core technology, AB-201 has shown excellent cancer cell elimination and tumor suppression by optimizing the CAR structure for activation within NK cells and maximizing persistence in the body, resulting in complete remission (CR) in preclinical trials.

In addition, the proprietary HER2-targeting CAR technology was patented in Australia in 2022 and is pending in five countries, including the U.S.

The trial filed by GC Cell is a multi-country, open-label, dose-escalation, and expansion phase 1 study in up to 48 patients with solid tumors HER2-overexpressing breast and gastric/gastroesophageal junction cancers and is designed to evaluate the safety and partial efficacy of AB-201 to establish a recommended phase 2 dose (RP2D).

This is the first clinical trial of AB-201 in humans, and by conducting the trial in both Korea and Australia, GC Cell will be able to obtain high-quality clinical data from a diverse population.

By selecting Peter MacCallum Hospital, a renowned hospital specializing in cancer in Australia, the company plans to secure competitiveness in global markets such as Europe and the U.S. by conducting systematic and reliable clinical trials based on the hospital's excellent medical system and medical staff network.

"We will be the fastest to enter clinical trials in the field of HER2-targeted allogeneic CAR-NK cell therapy globally," GC Cell CEO James Park said. "By applying GC Cell's global-level cell and gene therapy (CGT) technology to the HER2-targeting mechanism of action that has been proven in the field of cancer, we will develop allogeneic cytogenetic therapies that can be administered immediately when needed, dramatically increasing treatment opportunities and convenience for patients."