GC Cell said on Friday that it signed an agreement with IQVIA, the world's largest contract research organization (CRO), to conduct a multicountry phase 1 clinical trial of its CAR-NK cell therapy targeting solid tumors, AB201.
Accordingly, GC Cell plans to conduct multicountry clinical trials of AB-201, starting with Australia. AB-201 is an off-the-shelf cryopreservable allogeneic cell and gene therapy that targets solid tumors such as human epidermal growth factor receptor 2HER2-overexpressing breast and gastric cancers.
Compared to conventional cytogenetic therapies, it offers significant patient convenience and an efficient manufacturing process that can maximize commercialization benefits. Currently, commercialized chimeric antigen receptors (CAR)-T cell therapies are still limited to blood cancers. This is because the market expansion has been limited by high manufacturing costs, long process periods, and high treatment side effects such as cytokine release syndrome.
However, the allogeneic cell and gene therapy product, AB-201, has increased the persistence of cells in the body through GC Cell's own core technology. The mechanism of action is based on the proven HER2 targeting mechanism in solid cancers and the high safety of NK cell therapy.
The drug candidate demonstrated high-efficiency productivity compared to CAR-T, but also can be administered immediately according to the needs of patients at any time through cryopreservation.
In particular, AB-201 has high expression rate of HER2 CAR and other receptors such as NKG2D and NKp30, which are involved in NK cell activation, and has shown excellent cancer cell elimination and tumor suppression.
"Together with IQVIA's multiclinical trial which will begin in Australia, we will simultaneously pursue domestic clinical trials of AB-201, and aim to file an IND license within the year," said GC Cell CEO James Park. "We will subsequently accelerate the clinical development of the CD5-targeted CAR-NK therapy, AB-205 drug candidate, to develop first-in-class drugs that can provide various treatment options for solid cancer patients."