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  • K-Bios busy developing new CAR-NK cell therapies
  • by Son, Hyung Min | translator Alice Kang | 2025-03-17 06:00:04
To replace CAR-T cell therapies
GC Cell administers its CD5-targeted new drug candidate in a Phase I trial…targets T-cell lymphoma
Isu Abxis shows effect in preclinical trial…Vaxcell Bio Therapeutics, GI Cell, HK Inno.N also conducts development

The domestic pharmaceutical industry is initiating clinical trials for cell therapies and confirming new possibilities.

 

GC Cell, Isu Abxis, Vaxcell Bio Therapeutics, GI Cell, and HK Inno.N are developing CAR-NK (chimeric antigen receptor) cell therapies.

 

CAR-NK, which is derived from allogeneic cells, has the advantage of being able to compensate for side effects caused by the use of CAR-T cell therapies.

 

CAR-T induces cytokines such as interleukin (IL) associated with neurotoxicity, but activated NK cells generally produce interferon-gamma (IFN-γ) and granulocyte/macrophage colony-stimulating factor (GM-CSF).

 

As such, CAR-NK cell therapies are less likely to cause cytokine release syndrome (CRS) and neurotoxicity.

 

CAR-T cell therapy is an immune cell therapy drug created by combining genetic information that expresses CAR into the patient's T cells.

 

CAR-T has been proven effective in hematologic cancers and has been successfully commercialized, but its disadvantages include the lack of solid tumor indications, complex production process with CRS side effects, and high cost.

 

GC Cell drives the development of CAR-NK cell therapy#EB According to industry sources on the 15th, GC Cell has recently started the first patient administration of GCC2005 (AB-205), a CAR-NK cell therapy candidate, in a Phase I trial.

 

GCC2005 is a CAR-NK cell therapy that has improved the short duration of existing NK cells and enhanced efficacy by co-expressing CAR and IL-15.

 

GC Cell has developed a method for culturing large quantities of highly active, high-purity NK cells from a small amount of cord blood.

 

The Phase I trial aims to evaluate the safety and tolerability of GCC2005 in up to approximately 48 patients with relapsed/refractory NK and T-cell malignancies and to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D).

 

Artiva Biotherapeutics
Last November, GC Cell signed a third-party license agreement with its US affiliate, Artiva Biotherapeutics, and MSD to develop and commercialize two CAR-NK candidate substances, GC2005 and AB-201, using the affiliate’s intellectual property rights.

 

The three companies terminated their joint research agreement in June last year, but will now work together again with this agreement.

 

The candidate substances included in this contract utilize GC Cell’s CAR-NK platform technology and are new anticancer drug candidates that were previously developed through joint research between Artiva and MSD.

 

According to GC Cell, the difference between this contract and the contract terminated in June is the main entity for research and development.

 

CAR-NK development will be carried out by GC Cell, whereas Artiva was the main entity in the previous agreement.

 

GC Cell has secured global exclusive rights to the CAR-NK candidate substances and will lead the research and development (R&D) in the future.

 

In preclinical studies, GCC2005 showed anticancer effects in vivo in various CD5+ T-ALL models (RPMI-8402, CCRF-CEM).

 

GCC2005 showed higher survival rates and tumor suppression efficacy compared to the control (vehicle).

 

GC Cell is also developing the CAR-NK therapy AB-201.

 

AB-201 targets solid tumors such as HER2-overexpressing breast cancer and gastric cancer.

 

Artiva received approval from the US Food and Drug Administration (FDA) in 2022 for a Phase I/II clinical trial plan (IND) for AB-201.

 

Since then, GC Cell has been conducting clinical trials after receiving approval for the Phase 1 IND for AB-201 from the Ministry of Food and Drug Safety and the Human Research Ethics Committee (HREC) of Australia in December last year.

 

Through the trial, GC Cell plans to evaluate the safety and tolerability of AB-201 in patients with HER2-positive solid tumors and determine the recommended Phase II dose.

 

Domestic companies also confirm the possibility of developing CAR-NK cell therapies

Isu Abxis also recently released preclinical trial results and began full-scale development of CAR-NK cell therapies.

 

The company's ISU104, which is under development, targets the HER3 (ErbB3) protein, which is mainly expressed in breast cancer.

 

Isu Abxisand Seok-Ho Kim, a professor at Dong-A University's Department of Biomedical Engineering, has developed CAR-NK cells that have been engineered to express CAR cells targeting ErbB3 from cord blood-derived NK cells.

 

The results of the research showed that when treating breast cancer cell lines with CAR-NK cells, the cancer cells were killed.

 

Furthermore, in a mouse model implanted with breast cancer cells, ISU104-CAR-NK showed the effect of reducing the size of the tumor without any particular side effects.

 

To date, no HER3-targeted anticancer drugs have been developed yet.

 

Patritumab deruxtecan, an antibody-drug conjugate (ADC) that is in Phase II clinical trials by Daiichi Sankyo and MSD, is currently developed the furthest.

 

Last year, Vaxcell Bio signed a business agreement with Bio Design Lab, a virus vector design company, to jointly develop CAR-NK cell therapies for the treatment of autoimmune diseases.

 

Previously, Vaxcell Bio has signed MOUs with Bio Design Lab, Samsung Medical Center, and others to conduct research and development of new CAR-NK cell therapies.

 

Under this agreement, Vaxcell Bio will provide third-generation NK cells and oversee the entire process of CAR-NK development, including research and clinical trials that meet GMP standards.

 

Bio Design Lab will independently design and produce lentivirus vectors, one of the core technologies in CAR-NK cell therapy development.

 

GI Innovation's affiliates GI Cell and Y Biologics signed a memorandum of understanding last year and began developing CAR-NK anticancer drugs.

 

The two companies plan to develop anticancer drugs through GI Cell's CAR-NK cell therapy development and mass culture technology and Y Biologics' antibody discovery platform technology, Nanobody.

 

GI Cell has completed a Phase I clinical trial in Korea for its NK cell therapy, T.O.P.

 

NK, for patients with solid and hematological cancers.

 

After proving the tolerability and safety of T.O.P.

 

NK, GI Cell has been conducting a Phase IIa clinical trial since last month.

 

GI Cell is embarking on joint research with HK Inno.N for a CAR-NK cell therapy.

 

HK Inno.N and GI Cell are conducting basic research on 7 targets together.

 

HK Inno.N is conducting two basic research projects on its own in addition to the joint research.

 

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