GC Cell Signs Multinational Clinical Trial Agreement for CAR-NK Cell Therapy with IQVIA

CAR-NK Cell Therapy 'AB-201'
Clinical Trials Begin in Australia...Domestic Trials Also Planned

GC Cell (GCsel) announced on the 6th that it has signed a contract with IQVIA, the world's largest healthcare service provider, to conduct a multinational Phase 1 clinical trial of its chimeric antigen receptor (CAR)-natural killer (NK) cell therapy targeting solid tumors.

GC Cell logo. [Photo by GC Cell]

IQVIA conducts 16.7% of global clinical contract research and provides one-stop services from Phase 1 to 3 clinical trials, regulatory submissions, new drug launches, and commercialization. Through this contract with IQVIA, GC Cell plans to initiate the multinational clinical trial of 'AB-201' starting in Australia. Australia is recognized as a favorable environment for clinical trials due to its high-level medical infrastructure, advanced research capabilities, and ethnically diverse population.

GC Cell's CAR-NK cell therapy AB-201 is an "off-the-shelf" (standardized, ready-made), cryopreservable allogeneic cell and gene therapy targeting solid tumors such as HER2-overexpressing breast and gastric cancers. GC Cell explains that compared to existing cell and gene therapies, AB-201 enhances patient convenience and maximizes commercialization advantages through an efficient manufacturing process.

To date, commercialized CAR-T cell therapies have been limited to hematologic cancers. Moreover, autologous cell therapies using the patient’s own immune cells have faced market expansion limitations due to high manufacturing costs, lengthy processing times of 2 to 3 weeks, and treatment side effects such as cytokine release syndrome.

However, AB-201, an allogeneic cell and gene therapy, increases in vivo persistence of cells through GC Cell’s proprietary technology, based on the validated HER2-targeting mechanism in solid tumors and the safety profile of NK cell therapies. It also secures high production efficiency compared to CAR-T therapies and allows immediate administration as needed through cryopreservation.

GC Cell states that AB-201 exhibits high HER2 CAR expression rates and elevated expression of receptors involved in NK cell activation such as NKG2D and NKp30. They also added that in animal models of ovarian and gastric cancers, AB-201 demonstrated complete remission (CR), confirming excellent cancer cell elimination and tumor suppression capabilities.

James Park, CEO of GC Cell, said, "Through collaboration with IQVIA, we plan to simultaneously advance domestic clinical trials of AB-201 starting in Australia, aiming to submit the clinical trial application within this year." He added, "GC Cell will also accelerate clinical development of the CD5-targeting CAR-NK therapy pipeline AB-205, striving to develop the first-in-class new drugs that provide diverse treatment options for solid tumor patients and achieve tangible results."

This content was produced with the assistance of AI translation services.