The partnership brings QuantHealth's simulation platform into GCC2005's clinical development program, marking the company's entry into the Korean life sciences market

GC Cell, a leader in the cell and gene therapy (CGT) sector within the biopharmaceutical industry, and 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. For cell and gene therapies in particular, where patient populations are narrow and precedent is limited, the cost of getting a pivotal trial's design wrong is especially acute.

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 optimize the Phase 2 design for GCC2005 and reduce uncertainty in its global development program.

For a first-in-class therapy like GCC2005, where there is limited precedent to draw on, this allows GC Cell to stress-test multiple Phase 2 scenarios up front and enter the MRCT with a data-informed design rather than one based on assumptions alone. By collaborating with QuantHealth on a simulation-first approach to clinical development, GC Cell can test design assumptions — patient population, endpoints, comparator performance — against predictive models before committing them to protocol, rather than validating those choices only after a trial is underway.

"GC Cell is a recognized leader in Korea's life sciences market, and their adoption of a simulation-first approach further demonstrates their leadership and commitment to innovation. We are excited to help them optimize their clinical trial program, bringing more certainty to decisions about where patients are enrolled and where capital is spent,” said Orr Inbar, Co-Founder and CEO of QuantHealth. “This partnership also marks an important step in QuantHealth's global expansion — we're proud to have established our presence in Korea with GC Cell and look forward to continuing to expand into key markets worldwide.”

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. GC Cell has completed Phase 1a enrollment of GCC2005 in patients with difficult-to-treat T-cell lymphoma and is preparing to initiate a Phase 1b study in collaboration with leading clinical research institutions in Korea. Based on the Phase 1b results, GC Cell plans to advance GCC2005 into a Phase 2 MRCT for registration as part of its global development strategy.

"With AI-powered simulation capabilities, we expect this collaboration to enable a more rigorous and data-driven global clinical development strategy for GCC2005," said Sung Yong Won, CEO of GC Cell. "We aim to improve the probability of success and development efficiency of our future Phase 2 program and further strengthen the global competitiveness of GCC2005."

About GCC2005

GCC2005 is a fourth-generation CAR-NK cell therapy engineered to direct natural killer (NK) cells against CD5, a marker highly expressed in T-cell lymphoma. It is also designed to co-express interleukin-15 (IL-15) to enhance the in vivo persistence of immune cells. Through these features, GCC2005 is being developed as a next-generation therapeutic candidate with the potential to address limitations of existing treatment approaches.

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, manufacturing, commercialization, and distribution. More info: https://gccell.com/

About QuantHealth

QuantHealth is the global leader for AI clinical trial simulation, bringing together the industry’s most advanced clinical trial simulations portfolio — 600+ trial simulations across 30 diseases with up to 90% prediction accuracy — and the category's largest real-world data set to help life sciences and biotechnology organizations improve the potential of clinical trial successes. QuantHealth solutions use real-world data and predictive modeling to simulate trials at scale, optimize protocols, reduce risk, and accelerate timelines. The company has been a trusted partner for twelve of the top 20 global pharmaceutical companies.

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