BEIJING—CNGB Virogin, a joint venture between Virogin Biotech and China National Biotec Group, is poised to secure a breakthrough therapy designation (BTD) from China’s National Medical Products Administration (NMPA) for its innovative drug VG161. The targeted indication for this recombinant human IL12/15-PDL1B herpes simplex type I oncolytic virus injection is advanced hepatocellular carcinoma that has become refractory to standard treatment options.
VG161 has previously been granted approval for clinical studies in advanced metastatic adenocarcinoma of the stomach or gastroesophageal junction, as well as advanced solid tumors in China. The drug operates by activating the body’s innate anti-tumor immune response and stimulating adoptive anti-tumor immunity. Administered via intratumoral injection, VG161 leverages the natural process of viral replication to lyse tumor cells. Concurrently, the virus effectively expresses four immune-stimulatory factors, creating a synergistic effect that combines oncolytic activity with immune stimulation.
This potential BTD signifies a significant step forward in the development of VG161, reflecting its promise in addressing unmet medical needs for patients with advanced liver cancer. The therapy’s unique mechanism of action, which combines oncolysis with immune activation, positions it as a potentially transformative treatment in the oncology space.- Flcube.com
