GC Cell and BioCentriq® Execute Process Transfer Agreement in Anticipation of the U.S. entry of Immuncell-LC Inj

27 February 2024 | Tuesday | News


GC Cell, a fully integrated cell therapy pioneer has announced a strategic partnership with BioCentriq, a cell therapy contract development and manufacturing organization (CDMO) and US affiliate of GC Cell.
Image Source : Public Domain

Image Source : Public Domain

  • Immuncell-LC Inj. is an autologous Cytokine Induced Killer (CIK) cell therapy approved for Commercial use in South Korea as an adjuvant cell therapy for the treatment of Hepatocellular Carcinoma (HCC) after curative resection and has received FDA Orphan Drug Designations (ODDs) for liver, brain, and pancreatic cancers.
  • Immuncell-LC Inj. reduced HCC recurrence by 37% mortality by 79% in its Phase 3 study. 
  • Through this agreement with BioCentriq, GC Cell is accelerating the transfer of Immuncell-LC Inj. into the North American market in response to the significant attention it has garnered from leading US pharma and biotech companies with whom GC Cell is actively pursuing potential collaboration discussions.

This important partnership lays the foundation to bring GC Cells' proven cell-based immunotherapy, Immuncell-LC to the North American market. The execution of a Process Transfer Agreement with BioCentriq effectively lays the foundation for the U.S. launch of Immuncell-LC through utilization of BioCentriq's cell therapy process development, analytical method development and manufacturing expertise.

 

"The Process Transfer Agreement between GC Cell and BioCentriq initiates the groundwork for introducing Immuncell-LC to the U.S. market" said James Park, CEO of GC Cell. Our partnership with BioCentriq underscores our commitment to bringing innovative cancer therapies to patients in need across North America, marking a significant milestone in GC Cell's global expansion strategy."

"We are thrilled to partner with GC Cell to bring Immuncell-LC, a proven autologous cell therapy to the U.S. Market. Our partnership further enables our mission of Delivering Hope to cancer patients with significant unmet medical needs" said Jennifer Manning, Chief Commercial Officer, BioCentriq.

Immuncell-LC is the only commercially available adoptive cell therapy treatment of early-stage HCC. It is primarily composed of autologous, cultured blood-derived T lymphocytes with proven efficacy through a large-scale Phase 3 clinical trial which reduced the risk of recurrence by 37% and decreased the mortality rate by 79% compared to the control group. To date, Immuncell-LC has been administered to over 10,000 patients in South Korea without serious adverse events. 

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