NEW YORK – GC Cell and BioCentriq said Monday that they have inked a deal to bring GC Cell's autologous cytokine-induced killer (CIK) therapy, Immuncell-LC, to the US market.
As part of the deal, the Newark, New Jersey-based contract development and manufacturing organization (CDMO) BioCentriq will make available to GC Cell its process, analytical method, and manufacturing capabilities for producing Immuncell-LC.
The CIK therapy involves harvesting CIK cells from patients with hepatocellular carcinoma, incubating them with interleukin 2 and an antibody against CD3, then reinfusing them into patients. The treatment has been commercially approved in South Korea since 2007 as an adjuvant treatment for hepatocellular carcinoma.
In a South Korea-based 230-patient Phase III trial, treatment with Immuncell-LC reduced the risk of recurrence by 37 percent and decreased the mortality rate by 79 percent compared to a control group.
The US Food and Drug Administration has granted Immuncell-LC orphan drug designation in patients with liver, brain, and pancreatic cancer.
"The Process Transfer Agreement between GC Cell and BioCentriq initiates the groundwork for introducing Immuncell-LC to the US market," GC Cell CEO James Park said in a statement. "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."
BioCentriq, of note, was acquired by GC Holdings, the same company that owns GC Cell, in May 2022, making the firm and the CDMO affiliates.
Yongin, South Korea-based GC Cell said in a statement that it is actively pursuing collaborations with US pharma and biotech companies as part of its broader goal of expanding access to Immuncell-LC globally. In 2022, the firm inked a deal with Rivaara to develop the therapy in India.