Pharma Focus America

GC Cell and BioCentriq® Forge Process Transfer Agreement in Preparation for U.S. Introduction of Immuncell-LC Inj

Tuesday, February 27, 2024

GC Cell, a prominent figure in the field of fully integrated cell therapy, has formed a strategic partnership with BioCentriq, a notable contract development and manufacturing organization (CDMO) specializing in cell therapy and serving as the US affiliate of GC Cell. This significant collaboration paves the way for the introduction of GC Cell's established cell-based immunotherapy, Immuncell-LC, into the North American market. The officialization of a Process Transfer Agreement with BioCentriq serves as a fundamental step for Immuncell-LC's entry into the US, leveraging BioCentriq's expertise in cell therapy process development, analytical method development, and manufacturing.

GC Cell, stated, "The Process Transfer Agreement between GC Cell and BioCentriq establishes the foundation for Immuncell-LC's introduction to the US market. Our partnership with BioCentriq highlights our commitment to delivering innovative cancer therapies to patients in North America, marking a significant milestone in GC Cell's global expansion strategy."

BioCentriq, remarked, "We are excited to collaborate with GC Cell to bring Immuncell-LC, a proven autologous cell therapy, to the US market. This partnership further advances our mission of providing hope to cancer patients with significant unmet medical needs."

Immuncell-LC stands as the only commercially available adoptive cell therapy for early-stage HCC. It primarily comprises autologous, cultured blood-derived T lymphocytes, demonstrating proven efficacy through an extensive Phase 3 clinical trial. Results indicated a 37% reduction in the risk of recurrence and an impressive 79% decrease in mortality compared to the control group. With over 10,000 patients in South Korea having received Immuncell-LC without encountering serious adverse events, its safety and effectiveness profile are well-established.



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