ViGenCell said Wednesday that it has obtained approval from the Ministry of Food and Drug Safety (MFDS) to change the manufacturing source for its investigational new drug product, VT-Tri(1)-A, for acute myeloid leukemia (AML).

With the approval of the manufacturing source change for VT-Tri(1)-A, ViGenCell has changed the registering of its clinical trial drug manufacturing site for VT-Tri(1)-A from the Catholic Institute of Cell Therapy GMP to ViGenCell's state-of-the-art biopharmaceutical GMP center.

ViGenCell said the approval for changing its manufacturing source means the company has won recognition for its drug manufacturing and quality control capabilities using its in-house production facility, freeing it from reliance on external GMP production. The company added that it will also help reduce ancillary costs and accelerate and streamline clinical trials.

ViGenCell's pipeline VT-Tri(1)-A, a treatment for relapsed or refractory acute myeloid leukemia targeting multiple common antigens, is currently in cohort 2 of a phase 1 clinical trial. The safety and efficacy of VT-Tri(1)-A against a single WT1 tumor antigen (WT1-CTL) in patients with AML was established in an investigator-initiated study conducted from 2007 to 2013, with a relapse-free survival rate of 71 percent and a five-year relapse rate of 0 percent.