Helixmith to start gene, cell therapy CDMO business next year

Helixmith, a gene therapy company in Korea, will make a foray into the contract development and manufacturing organization (CDMO) market for gene and cellular therapy products next year, with a focus on the development of CAR-T therapies for local and global biotech firm in the early stages.

The company’s vision is to become a bio platform company dedicated to solutions related to almost every stage of a gene's life cycle based on its gene therapy development knowhow, Yu Seung-shin, Co-CEO of Helixmith, said at a press conference held on Wednesday.

Helixmith on Monday opened a gene and cell therapy plant for CDMO business.

The company expects more than 10 billion won ($8.55 million) in annual sales from CDMO business two to three years after its launch. Helixmith has identified some 40 firms as potential customers, including Cartexell, the company’s subsidiary for CAR-T therapy development.

Regarding the ongoing clinical trial of Engensis, the company’s investigational plasmid-based gene therapy that targets DPN, a complication of diabetes, Helixmith said it will complete all pivotal Phase 3 trials by 2023 and file a biologics license application with the FDA.

Engensis demonstrated efficacy in a 12-month Phase 3-1b study of 101 DPN patients after primary endpoints were not met in a nine-month Phase 3-1 study of 500 patients.

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