K-Pharma focuses on developing CAR-NK cell therapies

GC Cell receives approval for a Phase 1 trial in South Korea…aims to develop a treatment for T-cell lymphoma

GI Cell and Y-Biologics co-develop…TS Bio confirms effectiveness in a preclinical trial

Korean biopharmaceutical industry speeds up the development of chimeric antigen receptor (CAR)-NK cell therapy.

 

GC Cell has recently entered the Phase 1 clinical trial in South Korea.

 

Companies are collaborating on developing CAR-NK therapies through joint-research agreements: GI Cell and Y-Biologics and TS Bio and Maru Therapeutics.

 

NKMAX has confirmed the potential of its candidate in a preclinical study.

 

According to industry sources on August 19th, GC Cell received approval of Investigational New Drug (IND) application from the Ministry of Food and Drug Safety (MFDS) for a Phase 1 clinical trial of its CAR-NK therapy 'GCC2005' on August 14th.

 

GCC2005, an allogeneic cell therapy utilizing NK cells derived from umbilical cord blood, targets CD5, which is highly expressed in T-cell lymphoma.

 

CD5 is a biomarker highly expressed in many T-cell lymphoma subtypes.

 

GCC2005 is a CAR-NK cell therapy designed to co-express CAR and interleukin (IL)-15, improving the short persistence of existing NK cells and enhancing efficacy.

 

GC cell developed a technology to mass culture high-purity and highly active NK cells from a small quantity of umbilical cord.

 

CAR-NK, an allogeneic therapy, has the advantage of improving side effects compared to existing CAR-T therapies.

 

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

 

Accordingly, CAR-NK is less likely to cause cytokine release syndrome (CRS) or neurotoxicity.

 

GC2005 demonstrated anticancer effects in various in vivo CD5+ T-ALL models (RPMI-8402, CCRF-CEM).

 

GCC2005 showed a higher survival rate and tumor-suppressive efficacy than a vehicle.

 

Additionally, GC Cell is developing the CAR-NK cell therapy 'AB-201' with the U.S.

 

affiliate company Artiva.

 

AB-201 targets solid cancers, including HER2-overexpressed breast cancer and gastric cancer.

 

In 2022, Artiva received IND approval from the U.S.

 

Food and Drug Administration (FDA) for Phase 1/2 trials of its AB-201.

 

Then, in December last year, GC Cell received IND approval from the MFDS and Australia's Human Research Ethics Committees (HREC) for a Phase 1 trial of AB-201.

 

GC Cell and its U.S.

 

affiliate company Artiva is developing CAR-NK therapies (photo source=Artiva).

NKMAX is developing a CAR-NK candidate product, HER2 CAR-SNK02.

 

NKMAX's HER2 CAR-SNK02 comprises HER2 gene targeting CAR and a cytokine that prolongs survival and activation of NK cells in the body, which is then stored by cryo freezing.

 

Based on a preclinical study recently disclosed by NKMAX, HER2 CAR-SNK02 was confirmed to survive in vivo and exert anticancer effects in a mouse model engrafted with human gastric cancer cells.

 

Collaborative research to co-develop CAR-NK therapies

Korean biopharmaceutical companies are conducting collaborative research to develop CAR-NK therapies.

 

GI Cell, an affiliate of GI Innovation, and Y-Biologics have signed a collaborate research agreement last year, commencing the new CAR-NK anticancer drug development.

 

These companies plan to develop new anticancer drugs utilizing GI Cell's CAR-NK cell development and mass cell culture technology and Y-Biologics' nanobody-based antibody discovery platform technology.

 

GI Cell has previously completed the domestic Phase 1 trial of the NK cell therapy 'T.O.P.

 

NK' in patients with solid cancer and blood cancer.

 

Since GI Cell proved T.O.P.

 

NK's tolerability and safety, it began conducting a Phase 2a trial last month.

 

Additionally, GI Cell is conducting collaborative research with HK inno.N for CAR-NK.

 

HK inno.N and GI Cell are jointly conducting a basic research on CAR-NK targeting seven targets.

 

In addition to this joint research, HK inno.N is also conducting two basic research cases on its own.

 

TiCRos has entered into a license-based collaborative research agreement with Catherics, an Australian company focusing on developing iPSC-derived CAR-NK cell therapy.

 

Based on the agreement, the companies are developing CAR-NK therapy with improved tumor-killing effects by incorporating TiCRos' 'CLIP-CAR' on Catherics' CAR-NK therapy.

 

TiCRos will manufacture a CLIP-CAR targeting an antigen designated by Catherics.

 

Catherics will incorporate this into iPSC-derived NK cells and evaluate the function in vitro and in vivo.

 

TS Bio has been conducting joint research with Maru Therapeutics for CAR-NK cell therapy since last year.

 

Both companies plan to actively develop CAR-NK cell therapy targeting blood cancers and solid cancers through the agreement.