AB-201 CAR-NK Therapy Initiates Phase 1 Trials with Lunit AI

GC Cell, a leading cell therapy company in South Korea, has received approval from both Australian and Korean regulatory bodies to initiate Phase 1 clinical trials for its innovative AB-201 cancer treatment. This therapy, which targets HER2, utilizes chimeric antigen receptor-natural killer (CAR-NK) cells and has shown significant potential in preclinical studies. The treatment is expected to offer a new approach to managing advanced cancers, with a demonstrated persistence of over three months, a considerable improvement over existing NK cell therapies.

The AB-201 therapy is set to undergo a multi-country Phase 1 trial, which will assess its safety and efficacy in 48 patients with various HER2-overexpressing cancers. GC Cell has secured exclusive rights to AB-201 in the Asia Pacific region, while the rights outside this region have been granted to Artiva Biotherapeutics, Inc., marking a significant step forward in the global accessibility of this treatment.

In a strategic move to enhance the precision and intelligence of AB-201's efficacy evaluation, GC Cell has partnered with Lunit, a prominent player in the medical AI field. This collaboration aims to integrate advanced AI technology into the evaluation process, complementing traditional Immunohistochemistry (IHC) assessments. The partnership is expected to improve the accuracy of HER2 expression level assessments, which is crucial for making informed treatment decisions.

The integration of AI into pharmaceutical development is a growing trend, with a recent McKinsey report suggesting that AI could increase the value of the pharmaceutical R&D industry by billions of dollars. GC Cell's adoption of AI-driven imaging is anticipated to bring a higher level of precision and consistency to data analysis, thereby reducing the variability associated with individual interpretations.

AB-201 is an allogeneic CAR-NK cell therapy designed for treating solid tumors in an outpatient setting, with the possibility of repeat dosing. It features a novel high-affinity anti-HER2 antibody and a unique costimulatory structure, which contribute to its enhanced activity and persistence. The therapy has shown potent anti-tumor activity in preclinical models and is derived from umbilical cord blood donors with specific advantageous attributes.

GC Cell's focus on cell therapy extends across the entire bio healthcare spectrum, from diagnosis to treatment, encompassing R&D, production, commercialization, and distribution. The company's commitment to integrating digital and AI technology into healthcare is part of a broader strategy to prepare for the digital healthcare era and align with the industry's shift towards technology-enhanced solutions.