GC Green Cross Cell to Grow as a Specialized Immunotherapy Company: "Developing CAR-CIK Therapy"

by Ryu Hyunseok

Published 22 Mar.2021 09:43(KST)

[Asia Economy, Reporter Yoo Hyunseok] On March 22, GC Green Cross Cell announced its plans to grow into a specialized immunotherapy company, including the development of an off-the-shelf CAR-CIK therapy.

The company is currently expanding its business structure, which has been centered on the production and sales of Immuncell-LC, to include specialized CDMO (Contract Development and Manufacturing Organization) services for cell and gene therapies. It is also diversifying into other immunology-related businesses. Additionally, GC Green Cross Cell plans to develop next-generation, off-the-shelf cell therapies utilizing CAR-T technology, which is set to enter clinical trials in the United States.

CAR-T therapies have demonstrated excellent anticancer effects due to their powerful immune response. However, as autologous cell therapies, they must be manufactured for each individual patient, making mass production difficult. According to the company, CAR-CIK therapy addresses these limitations.

CIK (Cytokine-Induced Killer) cells are the main effector cell group in Immuncell-LC, possessing characteristics of both T cells and NK cells. CIK cells differentiated from cord blood generally exhibit low alloreactivity to HLA (human leukocyte antigen), which reduces the risk of graft-versus-host disease (GVHD), making them suitable for use as allogeneic cell therapies. Moreover, they are known to recognize and eliminate cancer cells without antigen presentation by MHC (major histocompatibility complex), effectively suppressing cancer cell recurrence and progression.

GC Green Cross Cell has secured platform technology for CAR-T therapies by leveraging CAR structures developed through its CAR-T research. By combining its experience in CIK therapy production, accumulated over more than 10 years of Immuncell-LC manufacturing, the company plans to develop an off-the-shelf, cryopreserved CAR-CIK therapy.

In addition, the company intends to focus on and expand its CDMO business for cell and gene therapies, which has gained global attention alongside the emergence of CAR-T therapies.

The Cell Center is equipped with state-of-the-art cGMP-level facilities and production systems optimized for cell therapy manufacturing. With advanced management and production systems in place, it is the largest facility in Korea that meets global standards for cell therapy production.

The company has already gained experience through numerous projects with partners such as Cellid, GC LabCell, and Artiva Biotherapeutics Inc. in the United States. Building on this experience, GC Green Cross Cell aims to become a global leader in the rapidly growing CDMO market.

The solid tumor-targeting CAR-T therapy currently under development is undergoing additional research to enter Phase 1/2a clinical trials in the United States. However, due to the ongoing COVID-19 pandemic in the U.S., the production schedule for cGMP clinical trial materials has been delayed. The company expects to submit an IND (Investigational New Drug) application within the second quarter of 2022.

Lee Deukjoo, CEO of GC Green Cross Cell, stated, “CIK cells are the main component of Immuncell-LC, and we have already produced this product for over 10 years, administering it to more than 5,000 patients. Due to the nature of cell therapies, maintaining consistent quality and anticancer efficacy is challenging, but our long-term manufacturing experience and track record put us in an optimal position to achieve strong results not only in CAR-CIK development but also in the CDMO business.”

He added, “If we succeed in developing an off-the-shelf, cryopreserved CAR-CIK therapy, cancer patients will be able to receive cell and gene therapy products in an off-the-shelf format, without restrictions related to blood collection, manufacturing time, or side effects.”