Boryung Vigencell, an affiliate of Korean drug maker Boryung Pharmaceutical, said on Dec. 28 that the country’s regulator has approved its Investigational New Drug application to initiate phase 2 clinical trials of its T-cell immunotherapy.
The company was able to create tumor-specific cytotoxic T-cells -- which play a vital role in the immune response against cancer -- by cultivating T-cells derived from blood. With the approval, Boryung Vigencell will now conduct studies of the drug candidate on patients with lymphoma caused by the Epstein-Barr virus.
Boryung Vigencell hopes to gain conditional approval from phase 2 studies to be given market access prior to phase 3 clinical trials. This would help the company commercialize the investigational drug as early as 2021 after completing the mid-stage studies.
Boryung Pharmaceutical acquired Vigencell, which was a biotech venture under the Catholic University of Korea, in 2016.
By Park Han-na (firstname.lastname@example.org)