SINGAPORE,Nov. 25,2024 -- SCG Cell Therapy Pte Ltd (SCG),a clinical-stage biotechnology company focused on developing innovative immunotherapies for infectious diseases and associated cancers,announced late-breaking data from its Phase 1 trial of SCG101,a first-in-class autologous hepatitis B virus (HBV)-specificT-cell receptor-engineered T Cell (TCR-T) therapytargeting hepatitis B surface antigen (HBsAg). The data was presented at the 2024 AASLD Liver Meeting in San Diego,United States.

In the Phase 1 clinical trial,SCG101 exhibited promising antiviral activity in patients with advanced HBV-related hepatocellular carcinoma (HBV-HCC). Among the 12 patients treated with a single intravenous dose of SCG101at 5.0×107 ~ 1.0×108 TCR+ T cells/kg,all patients demonstrated a significant reduction in serum HBsAg levels,with 11 out of 12 (92%) patients achieving a reduction of 1.0 to 4.6 log10,andthe levels remaining below 100 IU/mL throughout the follow-up period of up to one year. Notably,four patients (33%) experienced HBsAg loss within 21 days following a single infusion of SCG101 and which persisted throughout the follow-up.

The safety profile of SCG101 was generally favourable,with the therapy being well tolerated. The most commonly reported treatment-related adverse events included transient elevations in liver enzymes,pyrexia,cytopenia,cytokine release syndrome (CRS),hypoalbuminemia,and hyponatremia—consistent with SCG101's mechanism of action,which involves the HBsAg-targeted immune activation and its mediated clearance of diseased hepatocytes and HCC cells.

HBV remains a major global health burden,affecting over 250 million people worldwide. It is a leading cause of liver cancer,responsible for 50%–80% of hepatocellular carcinoma cases globally.1Chronic HBV infection leads to the integration of HBV DNA into the host genome,resulting in persistent HBsAg expression,chromosomal instability,and activation of oncogenes,thereby contributing to the development of hepatocellular carcinoma.2 SCG101 is designed to target a specific HBV peptide presented on infected cells,as well as hepatocytes with HBV DNA integration. By triggering both cytolytic and non-cytolytic mechanisms,SCG101 effectively eliminates HBV-infected hepatocytes as well as premalignant and HBV-HCC cells with HBV-DNA integration.

"The positive data from our Phase 1 trial marks a significant milestone in the development of SCG101,our first-in-class HBV-specific TCR-T therapy. These results not only demonstrate the potential of SCG101 to achieve meaningful and durable antiviral responses in patients,but also underscore the unique approach we are taking in HBV-specific TCR T cell therapy. We are encouraged by these early findings and are committed to advancing SCG101 through clinical development as we work towards providing a new therapeutic option for patients suffering from this challenging disease",said Christy Ma,Chief Executive Officer of SCG Cell Therapy. "We believe our GianTTM TCR discovery platform has the potential to address a broad spectrum of infection-associated cancers,such as human papillomavirus (HPV) associated cervical cancer and head and neck cancer,and Epstein-Barr virus (EBV) associated nasopharyngeal carcinoma and gastric cancer,paving the way for a new paradigm in immune-based cancer treatment".

About SCG101

SCG101 is an investigational autologous T-cell receptor (TCR) T cell therapy that targets a specific epitope of the hepatitis B surface antigen (HBsAg). Leveraging SCG's proprietary GianTTM technology,our TCR screening platform identifies high-affinity and high-avidity natural TCRs against intracellular antigens presented via the major histocompatibility complex (MHC) in solid tumors. Both preclinical and clinical studies of SCG101 have demonstrated significant tumor inhibition and the eradication of HBV covalently closed circular DNA (cccDNA). SCG101 has received clinical trial approvals from the U.S. Food and Drug Administration (FDA),the China National Medical Products Administration (NMPA),the Singapore Health Sciences Authority (HSA),and the Hong Kong Department of Health (DOH) for the treatment of patients with HBV-related hepatocellular carcinoma (HCC). A Phase 1/2 clinical trial evaluating SCG101 is currently underway (NCT05417932).

About Hepatocellular carcinoma

Hepatocellular carcinoma (HCC) is the most common type of liver cancer. In 2020,it was estimated that over 905,000 new cases of liver cancer were diagnosed,and more than 830,100 deaths occurred globally,making it one of the leading causes of cancer-related mortality.3 Chronic hepatitis B virus (HBV) infection is responsible for at least 50% of HCC cases worldwide.1 HCC is typically diagnosed at an advanced stage,contributing to a poor prognosis with a five-year survival rate of less than 15%.4

About SCG Cell Therapy

SCG Cell Therapy is a leading biotechnology company dedicated to developing novel immunotherapies for infectious diseases and associated cancers. The company focuses on targeting some of the most common cancer-causing infections,including Helicobacter pylori,HPV,HBV,and EBV. SCG is advancing a broad pipeline of TCR-based therapeutics aimed at preventing and curing infection-related cancers. Headquartered in Singapore,SCG operates across Singapore,China,and Germany,leveraging regional strengths to cover the entire value chain,from innovative drug research and discovery to manufacturing,clinical development,and commercialization. For more information,please visit www.scgcell.com.

[1]Y,Xie. (2017). Hepatitis B virus-associated hepatocellular carcinoma. Advances in experimental medicine and biology.

[2]Jiang,Y.,Han,Q.,Zhao,H.,Zhang,J. (2021,May 20). The mechanisms of HBV-induced hepatocellular carcinoma. Journal of hepatocellular carcinoma.

[3]Liver cancer statistics: World cancer research fund international. WCRF International. (2022,April 14).

[4] Golabi P,Fazel S,Otgonsuren M,Sayiner M,Locklear CT,Younossi ZM. (2017). Mortality assessment of patients with hepatocellular carcinoma according to underlying disease and treatment modalities.