South Korea's first CAR-NK cell therapy cleared for human trials in Australia and domestically; Cancer Moonshot participant GC Cell partnering with medical AI leader Lunit to collaborate on AB-201 clinical development

YONGIN, South Korea and SYDNEY, Jan. 9, 2024 /PRNewswire/ -- GC Cell, a fully integrated cell therapy pioneer, is proud to announce the approval from both the Australian Human Research Ethics Committee (HREC) and the Korean Ministry of Food and Drug Safety (MFDS) for a Phase 1 Investigational New Drug (IND) trial for its AB-201 cancer treatment, a HER2 targeted chimeric antigen receptor-natural killer (CAR-NK) cell therapy that shows great promise. Additionally, GC Cell is excited to reveal a strategic partnership with Lunit, the medical AI leader, to enhance precision and clinical intelligence of AB-201's efficacy evaluation by applying its advanced AI technology, in addition to traditional Immunohistochemistry (IHC) based assessments. After participating in the US White House's Cancer Moonshot initiative this past October, both accomplishments represent major milestones in GC Cell's efforts to revolutionize immunotherapy-based cancer treatment while harnessing AI and digital transformation to fight cancer.

"Our preclinical studies suggest the possibility that AB-201 causes complete cancer remission and tumor suppression," remarked James Park, CEO of GC Cell. "We are thrilled to move forward to Phase 1 trials — the first Korean company to do so for CAR-NK cell therapy — and we are grateful to Lunit for joining hands with us in our digital transformation and the fight against cancer — now armed with the power of AI. This initiative is part of GC Cell's broader strategy to integrate digital & AI technology into all aspects of healthcare, from research and development to patient care. I believe it will prepare our company for the upcoming era of digital healthcare."

Promising treatment to begin clinical trials

AB-201, a novel CAR-NK cell therapy targeting solid tumors, represents a breakthrough in cancer immunotherapy, capable of killing malignant cells. While existing NK cell treatments typically dissipate within a few weeks, AB-201 has demonstrated persistence for over three months in preclinical studies, highlighting its potential in managing long-term, advanced cancers. A multi-country study, the Phase 1 trial will evaluate safety and efficacy in 48 patients with HER2-overexpressing breast, gastric, and gastroesophageal junction cancers. GC Cell holds exclusive rights to AB-201 in the Asia Pacific region, while ex-Asia-Pacific rights were licensed to Artiva Biotherapeutics, Inc. in an exclusive partnership. 

Lunit partnership for AI-powered pharma development

A recent McKinsey report found that AI has the potential to increase the value of the pharmaceutical R&D industry by six to eleven billion US dollars. Employing the technology, GC Cell anticipates that AI-driven imaging can analyze vast amounts of data with a high degree of precision and consistency while reducing variability by individual interpretation. This leads to a more accurate assessment of HER2 expression levels, which is vital for appropriate treatment decisions. With such quantitative analysis, AI can help standardize the assessment of cancer target expression across different laboratories and geographical locations. This standardization is essential for multicenter clinical trials and for ensuring that patients receive consistent care regardless of where they are treated. It's a pivotal step in GC Cell's journey towards a digital future, aligning with the broader healthcare industry's shift towards technology-enhanced solutions.

About AB-201

AB-201 is an allogeneic HER2-targeted chimeric antigen receptor NK (CAR-NK) cell therapy for the treatment of solid tumors in the outpatient setting with the option for repeat dosing. A novel, high affinity anti-HER2 antibody converted to scFv structure confers highly specific tumor targeting and is coupled with a unique costimulatory structure and IL-15 expression for enhanced activity and persistence. AB-201 has demonstrated potent anti-tumor activity in multiple preclinical HER2-positive tumor model systems. The underlying NK cell is derived from umbilical cord blood donors preselected for advantageous attributes including the high affinity variant of the CD16 receptor and a KIR-B haplotype. AB-201 cell products maintain high expression of CD16, as well as other activating innate cell tumor engaging receptors, enabling the potential for dual targeting therapeutic approaches via monoclonal antibody combinations. The resulting CAR-NK is manufactured at very large scale and cryopreserved in infusion-ready media to enable repeat clinical administrations in the outpatient setting.

GC Cell holds exclusive rights to AB-201 in the Asia-Pacific region, while ex-Asia-Pacific rights were licensed to Artiva Biotherapeutics, Inc. in an exclusive partnership. The U.S. Food and Drug Administration previously cleared Artiva's investigational new drug (IND) application for AB-201 in 2022.

About GC Cell

With a core focus on cell therapy, GC Cell offers complete bio healthcare solutions from diagnosis to treatment, and the brand's comprehensive value chain spans R&D, production, commercialization, and distribution.

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