SCG Cell Therapy announces latest clinical data at AASLD showing SCG101 improves tumor response and achieves sustained antiviral activity in patients with advanced HBV-related hepatocellular carcinoma

Singapore, November 13, 2023 /PRNewswire/ — SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company developing novel immunotherapies for infectious diseases and their related cancers, today announced the latest in its first-in-class autologous hepatitis B virus Clinical Data for (HBV)-Specific T Cell Receptor Engineered T Cell (TCR-T) Therapy – SCG101 – Presented at the 2023 AASLD Liver Meeting boston, USA.

Results from a first-in-human clinical trial indicate that SCG101 exhibits promising antiviral and antitumor activity in patients with advanced HBV-related hepatocellular carcinoma (HCC). Six patients with advanced HBV-HCC received a single intravenous injection of 5.0×10 SCG101⁷ ~1.0×10⁸ TCR+ T cells/kg, 2 of 6 patients (33%) achieved partial response (PR), 2 of 6 patients had stable disease (SD), and tumor shrinkage was observed.

Tumor response was highly correlated with the antiviral activity of SCG101. At data cutoff, 6 of 6 patients (100%) experienced serum HBsAg reductions, and 4 of 6 patients (67%) achieved 1 to 3 log reductions following SCG101 infusion. HBsAg levels remained ≤20 IU/mL during follow-up up to 90 weeks. Tumor shrinkage was observed in all 4 patients with >1 log reduction in serum HBsAg, and median progression-free survival (PFS) was longer in patients with >1 log reduction in HBsAg than in patients without >1 log reduction (25.8 weeks vs. 3.1 week).

Safety analysis showed that SCG101 was generally well tolerated, with no cases of serious adverse events or immune effector cell-related neurotoxic syndrome. The most common treatment-related adverse events were transient liver enzyme assessment, cytokine release syndrome (CRS), and fever, which were expected due to SCG101’s mechanisms of clearance of diseased hepatocytes and immune activation.

HBV infection is the leading cause of liver cancer, accounting for 50%-80% of hepatocellular carcinoma cases worldwide.⁽¹⁾ HBV DNA integrates into the host genome, causing genetic instability of host cells and epigenetic remodeling of host DNA, leading to abnormal expression of oncogenes and HBV antigens.⁽²⁾ SCG101 can specifically target HBV peptides present on HBV-HCC tumor cells, precancerous liver cells integrated with HBV-DNA, and HBV-infected cells, triggering cytolytic and non-cytolytic mechanisms to eliminate tumor cells and HBV-infected cells.

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“We are pleased to be the first to demonstrate the potential of HBV TCR T-cell therapy to achieve promising tumor responses and induce durable antiviral activity in solid tumors. This unique dual functionality of SCG101 provides a means to achieve promising tumor responses and induce durable antiviral activity by targeting New approach to treat HBV-related HCC root cause of cancer,” says frank king, CEO of SCG Cell Therapy. “We believe in our giants^{TM value} TCR discovery platforms have the potential to address a wide range of infection-related cancers, such as Epstein-Barr virus (EBV), human papillomavirus (HPV), and ultimately establish a new paradigm in immune cancer treat”.

About SCG101

SCG101 is an autologous T cell receptor (TCR) T cell therapy and an investigational cell therapy product targeting specific epitopes of hepatitis B surface antigen (HBsAg). Leveraging SCG’s proprietary Giant^{TM value} Using this technology, high-affinity and high-affinity native TCRs can be identified against intracellular antigens presented by the major histocompatibility complex (MHC) in solid tumors. Preclinical and clinical studies with SCG101 demonstrated tumor inhibition and eradication of HBV cccDNA. SCG101 has been approved by the U.S. Food and Drug Administration (FDA), China’s National Medical Products Administration (NMPA), Singapore’s Health Sciences Authority (HSA), and Hong Kong’s Department of Health (DOH) for the treatment of patients with hepatitis B-associated liver cancer. Clinical Trials. A Phase 1/2 clinical trial evaluating SCG101 is ongoing (NCT05417932).

About hepatocellular carcinoma

Hepatocellular carcinoma (HCC) is the most common type of liver cancer. It is estimated that there will be more than 905,000 new cases of liver cancer and more than 830,100 deaths worldwide in 2020, making it one of the leading causes of cancer death worldwide.⁽³⁾ Chronic hepatitis B virus infection accounts for at least 50% of liver cancer cases worldwide.⁽¹⁾ HCC is often diagnosed at an advanced stage and carries a poor prognosis. The five-year survival rate is less than 15%.⁽⁴⁾

About SCG Cell Therapy

SCG is a leading biotechnology company focused on developing novel immunotherapies for infections and their associated cancers. The company targets the most common cancer-causing infections: Helicobacter pylori, HPV, HBV and EBV, and develops a broad and unique portfolio of T-cell therapies, antibodies and therapeutic vaccines to prevent and treat related cancers.Established and headquartered in SingaporeSCG combines regional advantages Singapore, China and GermanyCovering the entire value chain from innovative drug research and development, manufacturing, clinical development to commercialization. For more information about SCG, please visit our website at www.scgcell.com.

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Source: SCG