ViGenCell said Wednesday it has signed a joint development agreement with Therabest for TB-420, an iPSC-derived NK cell therapy expressing GPC3 CAR to treat hepatocellular carcinoma.

Under this agreement, ViGenCell will pay Therabest a contract fee of 4 billion won ($2.8 million), along with milestone payments based on development stages. Revenue will be shared according to a mutually agreed ratio upon technology transfer and upon the generation of independent sales.

ViGenCell and Therabest plan to accelerate development by combining their respective technological capabilities and networks, targeting the clinical entry and global technology transfer of TB-302 and TB-420.

Following the joint R&D agreement signed in April for the GD2 CAR-NK cell therapy pipeline TB-302 (VC-302 in ViGenCell’s pipeline name) targeting glioblastoma and other intractable brain tumors, ViGenCell has decided to extend its collaboration with Therabest into the field of hepatocellular carcinoma (HCC) therapy development with the introduction of the new candidate TB-420.

The iPSC-derived GPC3 CAR-NK cell therapy, TB-420, introduced by ViGenCell, is described as capable of recognizing GPC3, a hepatocellular carcinoma-specific antigen, to selectively eliminate HCC tumors. Furthermore, it can target non-GPC3-expressing HCC cells and liver fibrosis-inducing cells through various NK cell activity receptors.

Furthermore, it is expected to be a suitable new drug for the treatment and management of hepatocellular carcinoma, which has high tumor heterogeneity and vulnerable patient liver function, due to its safety profile regarding cell therapy-related side effects (CRS, ICANS, and others) as it secretes very low levels of inflammatory factors.

“TB-420 utilizes iPSCs as the source cells, enabling large-scale production of NK cells with uniform quality. This allows for the supply of the therapeutic at a very reasonable price compared to existing CAR-T therapies,” ViGenCell CEO Ki Pyung-suk said. “Hepatocellular carcinoma affects over 600,000 new patients globally each year, presenting significant unmet needs due to its low survival rate and high recurrence rate. We will dedicate our R&D efforts to provide patients with a promising treatment alternative while enhancing ViGenCell's value.”

Following the signing of a 5.2 billion won contract development and manufacturing (CDMO) agreement with Therabest, ViGenCell plans to commence production of clinical trial drugs for a total of four pipelines, including the joint development project with Therabest. Production is scheduled to begin at the ViGenCell GMP Center, with a target shipment date in the first half of next year.