GC Cell's 'AB-201' Approved for Phase 1 Clinical Trials in Korea and Australia: "First in Korea"

GC Cell (GCsel) is launching clinical trials for the development of the first cell therapy in Korea.

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Photo by GC Cell

On the 22nd, GC Cell announced that it has received approval for the Phase 1 clinical trial application (IND) of ‘AB-201,’ an allogeneic chimeric antigen receptor (CAR)-natural killer (NK) cell therapy targeting solid tumors, from the Ministry of Food and Drug Safety and the Australian Human Research Ethics Committee (HREC).

This Phase 1 clinical trial entry of AB-201 is the first clinical trial in Korea to administer an allogeneic CAR-NK cell therapy using donor cells targeting solid tumors. GC Cell plans to evaluate the safety and anti-tumor activity of AB-201 in 48 patients with solid tumors, specifically ‘human epidermal growth factor receptor 2 (HER2) overexpressing breast cancer’ and ‘gastric cancer and gastroesophageal junction cancer.’

The trial will be conducted as a multinational, open-label, dose-escalation and expansion study. Initially, in the dose-escalation phase (Phase 1a), the safety of the therapy will be confirmed by increasing the dose up to four levels or reducing it by one level. The actual clinical trial is scheduled to begin in the first half of next year.

AB-201 is a cell therapy using a fourth-generation CAR transgene optimized for activation within NK cells. Compared to NK cells that disappear within 2 to 3 weeks after injection, preclinical trials confirmed that AB-201 shows persistence of over three months in the body. Additionally, GC Cell’s industry-leading large-scale cell therapy culture and cryopreservation technology is expected to provide treatment to many patients within a reasonable time and cost.

According to the National Cancer Information Center’s international comparison of cancer incidence, Australia’s cancer incidence rate is 452.4 per 100,000 population, higher than the OECD average of 300.9, ranking first among surveyed countries. As of last year, more than 20,000 new breast cancer cases were diagnosed in Australia, showing the second highest incidence after prostate cancer. In Korea, according to the 2020 domestic top 10 cancer incidence statistics, the incidence rates of gastric cancer and breast cancer were 51.9 and 48.5 per 100,000 population respectively, placing them among the top five cancers by incidence.

James Park, CEO of GC Cell, stated, “We plan to strengthen GC Cell-led research and development (R&D) to solve intractable diseases, starting with cancer. We will lead global research and clinical trials in the HER2-targeting allogeneic CAR-NK field and, based on our global-level cell and gene therapy (CGT) R&D capabilities, take the lead in increasing treatment opportunities and convenience for many patients both domestically and internationally.”