SCG101 will be evaluated in trials across China, Singapore, and the US.
The FDA has cleared SCG Cell Therapy’s investigational new drug application for their T-cell receptor (TCR) T cell therapy SCG101 for hepatitis B virus (HBV)-related liver cancer.
The clearance follows previous IND approvals from China National Medical Products Administration in March 2022 and Singapore Health Sciences Authority in May 2022. It paves the way for SCG to initiate global phase 1/2 clinical trials to evaluate SCG101 across China, Singapore, and the US. A phase 1/2 trial is currently underway (NCT05417932).
"Clearance of the IND for SCG's leading cell therapy product SCG101 across the United States and Asia is an important milestone for the company," Frank Wang, chief executive officer, SCG Cell Therapy, said in a statement. "We are eager to start international multicenter clinical trial that utilizes our TCR-T technologies to offer innovative treatment option for patients [sic]."
SCG101 is an autologous TCR T cell therapy developed using SCG's proprietary technology that is designed to recognize HBV-derived T cell epitopes and redirect T cells specifically against the HBV antigen. The therapy then targets and eliminates HBsAg-positive HCC cells as well as HBV covalently closed circular DNA (cccDNA). SCG101 has previously demonstrated its ability to inhibit tumors and eradicate cccDNA in preclinical studies.
SCG previously presented data from an investigator-initiated clinical trial of SCG101 at the International Liver Congress (ILC) 2022, June 22-26. These data, from 3 patients, with advanced HBV-related hepatocellular carcinoma and at least 2 prior cancer therapies, showed significant antiviral activity and tumor control. Two patients experienced lesion shrinkage as well as rapid and significant serum HBsAg reduction from a baseline of 1,004.3 IU/mL and 521.6 IU/ML to 23.8 IU/mL and 9.1 IU/mL at 28 days after treatment and further reduced to 14.0 IU/m and 0.3 IU/mL at 60 days after treatment.
"Our previous preclinical and clinical studies demonstrated that SCG101 has dual antiviral and antitumor activities, which is a profoundly important and exciting clinical proof-of-concept for SCG in cancer drug development," Ke Zhang, PhD, chief scientific officer, SCG Cell Therapy, added to the statement. "We believe tumor microenvironment is a major barrier to successful cell therapy in solid tumors. Redirecting T cells specifically against HBsAg-positive HCC cells as well as HBV-infected cells could potentially induce immunological cascades altering the tumor microenvironment and offer a path forward to better outcomes for patients."