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South Korea-based GC Cell, a leader in the cell and gene therapy (CGT) sector within the biopharmaceutical industry, and Israel-based QuantHealth, the global leader in AI-powered clinical trial simulation, have announced a collaboration to bring a simulation-first approach to the design of upcoming clinical trials for GCC2005, GC Cell's investigational CD5-targeted CAR-NK cell therapy for T-cell lymphoma.
The collaboration is intended to advance GCC2005's global clinical development strategy and enhance the design of a planned Phase 2 multi-regional clinical trial (MRCT), using simulation to inform key design decisions before a single patient is enrolled.
Drug development is a costly and laborious process, costing $2 billion to $3 billion per approved drug and taking more than a decade from early-stage discovery to regulatory approval. Despite that investment, roughly nine out of ten drug candidates that enter clinical trials ultimately fail — a rate that climbs even higher once preclinical attrition is included.
Under the agreement, QuantHealth will apply its AI-powered clinical trial simulation platform to predict treatment responses across different patient populations, assess efficacy outcomes, conduct comparative analyses against competing therapies, and evaluate a range of clinical trial scenarios.
GC Cell will use these insights to refine key trial design elements, including patient selection criteria and study endpoints, to optimise the Phase 2 design for GCC2005 and reduce uncertainty in its global development programme.
GCC2005 is an allogeneic CAR-NK cell therapy candidate targeting CD5, being developed as a potential first-in-class treatment for difficult-to-treat T-cell lymphoma, and is one of GC Cell's key clinical-stage pipeline assets.
