SCG Announces Late-Breaking Clinical Data of SCG101 in HBV-Related Hepatocellular Carcinoma Presented at EASL 2025

SINGAPORE,May 8, 2025/PRNewswire/ -- SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company pioneering TCR T cell therapy for infectious diseases and associated cancers, today announced late-breaking clinical data from its Phase 1 trial evaluating SCG101, autologous HBV-specific TCR-T cell therapy, in patients with advanced HBV-related hepatocellular carcinoma (HCC). These data were presented at the European Association for the Study of the Liver (EASL) Congress 2025.

The results demonstrated that SCG101 led to sustained clearance of serum hepatitis B surface antigen (HBsAg) and HBV-DNA in heavily pre-treated patients with HBV-related HCC. Notably, 94% of patients had received prior nucleoside analogue (NA) antiviral therapy, and 72% presented with liver cirrhosis at baseline. Following a single-dose SCG101 infusion, all treated patients experienced a rapid decline in serum HBsAg, with 94% (16/17) achieving a 1.0–4.6 log₁₀ reduction within 28 days and persisting< 100 lU/mL for up to 1 year. Notably, 4 patients (23.5%) achieved HBsAg loss.

In addition to its antiviral effects, SCG101 demonstrated encouraging antitumor activity. All patients had received at least 2 prior lines of systemic cancer treatment, including immune checkpoint inhibitors. Despite this heavily pre-treated population, 8 out of 17 patients (47%) showed measurable tumour regression. At the time of data cutoff, median overall survival (OS) had not yet been reached.

SCG101 was generally well tolerated, with a good safety profile. Transient alanine aminotransferase (ALT) elevation, consistent with the cytolytic mechanism of SCG101, was observed in 94% of patients and resolved within 14 days. Other common treatment-related adverse events (TRAEs) included cytokine release syndrome (CRS), neutropenia, and thrombocytopenia—all of which were manageable and reversible.

Prof. Dr.Shunda Du, Chief of Liver Surgery Department, Peking Union Medical College Hospital, said:"The dual antiviral and antitumor effects observed with SCG101 are highly promising, especially in this heavily pre-treated patient population. The sustained HBsAg clearance and tumour response suggest that SCG101 may offer a novel immunotherapeutic option for patients with HBV-related HCC, addressing an area of significant unmet clinical need".

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.¹ Chronic 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 selectively target and eliminate HBV-infected hepatocytes and HCC cells by recognizing specific epitope of HBV surface antigen (HBsAg) presented via the major histocompatibility complex (MHC). 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.  

"These positive data mark an important step forward in the development of SCG101 and validate our approach of harnessing precision T cell therapy to target chronic HBV infection and HBV-related liver cancer,"saidChristy Ma, Chief Executive Officer of SCG Cell Therapy."SCG101 is the first TCR-T cell therapy to demonstrate both virologic clearance and tumour regression in HBV-related HCC patients. We are encouraged by the data, and we look forward to advancing SCG101 through further clinical development to bring this potentially curative therapy to patients in need."

About SCG101

SCG101 is an investigational autologous T cell receptor (TCR) T cell therapy designed to selectively target specific epitope of the hepatitis B surface antigen (HBsAg). Powered by SCG's proprietary GianT™ TCR screening platform, which enables the discovery of natural, high-affinity, high-avidity TCRs against intracellular antigens presented via the major histocompatibility complex (MHC). SCG101 delivers precise immune-mediated clearance of infected and malignant cells demonstrating significant tumour inhibition and the eradication of HBV covalently closed circular DNA (cccDNA) in preclinical and clinical studies.

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.³Chronic hepatitis B virus (HBV) infection is responsible for at least 50% of HCC cases worldwide.¹HCC 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 inSingapore, SCG operates acrossSingapore,China, andGermany, 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 visitwww.scgcell.com.

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SOURCE SCG Cell Therapy Pte Ltd