기업
BiocurePharm begins preclinical study of 'anti-CD19 CAR-T'
바이오스펙테이터 Jongwon Jang 기자
BiocurePharm and PharosVaccine have started a preclinical study for the development of anti-CD19 chimeric antigen receptor-T (CAR-T) cell therapy that can strengthen the capacity to kill a target tumor cell using a T cell in cell-mediated immunity.
BiocurePharm said on February 21 that following a research contract with Osong Medical Innovation Foundation, it will investigate in vivo distribution behavior and other toxicological profiles for anti-CD19 CAR-T cell therapy in nude mouse models.
The preclinical trial, which will be conducted for the first time in Korea, is designed to file an Investigational New Drug application for authorization from the Ministry of Food and Drug Safety.
Anticipating that the preclinical study will be finalized sooner than expected, BiocurePharm added that for clinically available Lentiviral vector production, CdmoGen has been manufacturing master cell bank (MCB) from the end of 2017.
"Presently, our MCB production is now in the final stage, and the preclinical study period is estimated to take about 3 or 4 months," said an official at BiocurePharm.
"We plan to conduct Phase I clinical trials in Korea and Germany in August 2018."
Based on the clinical implications of CAR-T immunotherapy that can treat intractable acute leukemia, BiocurePharm expects that the oncoming clinical trial can be started earlier, in comparison with other studies targeting other diseases. The company will seek regulatory approval from 2019.
