ingapore-based SCG Cell Therapy Pte Ltd ("SCG") announced that U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for SCG101, an investigational T-cell receptor (TCR) T cell therapy for patients with hepatitis B virus (HBV) related liver cancer. This clearance initiates the advancement of SCG101 Phase 1/2 clinical trials globally.

This announcement follows SCG's previous IND approvals from China National Medical Products Administration (NMPA) in March 2022 and Singapore Health Sciences Authority (HSA) in May 2022. This further establishes SCG101 as the first TCR-T cell therapy product approved for clinical trial across the U.S, China and Singapore.

"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," said Frank Wang, Chief Executive Officer of SCG Cell Therapy. "We are eager to start international multicenter clinical trial that utilizes our TCR-T technologies to offer innovative treatment option for patients."

SCG101 is an autologous TCR T cell therapy that can recognize HBV-derived T cell epitope presented on the cell surface by specific major histocompatibility complex (MHC) class I molecules. With the specific HLA typing, SCG101 can redirect T cells specifically against the HBV antigen not only to target and eliminate HBsAg-positive HCC cells but also to eradicate HBV cccDNA (covalently closed circular DNA).

"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," stated Ke Zhang, PhD, Chief Scientific Officer of SCG Cell Therapy. "We believe tumour microenvironment is a major barrier to successful cell therapy in solid tumours. Redirecting T cells specifically against HBsAg-positive HCC cells as well as HBV-infected cells could potentially induce immunological cascades altering the tumour microenvironment and offer a path forward to better outcomes for patients."

In June 2022, SCG Cell Therapy presented interim data from an investigator-initiated clinical trial of SCG101 at the International Liver Congress (ILC) 2022, the 57^th EASL Annual Meeting. The trial evaluated single-dose SCG101 in patients with advanced HBV-related hepatocellular carcinoma (HCC) who had received at least two prior cancer therapies. The data showed significant antiviral activity and tumour control. Two out of three patients observed 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 in just 28 days from SCG101 treatment and further reduced to 14.0 IU/m and 0.3 IU/mL within 60 days from treatment.