Kolon TissueGene cleared to resume US Phase III trial for Invossa

South Korean cell and gene therapies company Kolon Life Science (Kosdaq: 950160) saw its shares leap 30% to 26,900 won on Monday, after it announced that the clinical hold issued by the US Food and Drug Administration in April 2019 has been lifted effective April 10, 2020, and that the company can continue with its knee osteoarthritis (OA) Phase III clinical trial of Invossa (TG-C).

The trial had been suspended due to product identity concerns, the company noted, adding that the firm’s US unit, Kolon TissueGene, has begun activities to resume the Phase III trial and reinitiate enrollment later this year.

The clinical exploration was halted last May after Invossa’s cell line was found to have been mislabeled as cartilage-derived, although it was kidney-derived cells with tumorigenicity. The drug was approved in 2017 as Korea’s first gene therapy, but the mislabeling led to marketing suspension and license revocation in Korea last year, according to Pulse News Korea and other media reports.