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

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. (Link)

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.

YONGIN, South Korea and NEWARK, N.J., Feb. 26, 2024 /PRNewswire/ -- 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. This important partnership lays the foundation to bring GC CellsGC 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.

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来源: PRNewswire

"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 CellGC 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.

About GC Cell

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

About BioCentriq

BioCentriq is a global cell therapy Contract Development and Manufacturing Organization (CDMO) with a proven track record successfully transferring, developing, and manufacturing GMP drug product for use in clinical trials since 2022. With industry-recognized leadership, scientists, engineers, analysts, and manufacturing specialists, along with established quality systems and modern infrastructure, BioCentriq is a trusted strategic partner for the development and manufacture of both autologous and allogeneic cell therapies and cell-based immunotherapies.

In June 2023, BioCentriq launched its LEAP™ Advanced Therapy Platform designed to help cell therapy developers move from contract to clinic in as little as six months. Our newly constructed, modern facilities feature flexible GMP manufacturing suites and fully equipped process development, quality control and analytical method development laboratories. The company was purchased by GC Holdings Inc. of South Korea for $73 million in May 2022. More info: www.biocentriq.com

SOURCE GC Cell

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