SINGAPORE, November 14, 2023 /PRNewswire/ — SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company developing novel immunotherapies for infectious diseases and their associated cancers, today announced the latest clinical data from its first autologous virus. hepatitis B (HBV-specific T-cell therapy (TCR-T)) – SCG101 – at the AASLD Liver Meeting 2023 in Boston, UNITED STATES.
Results from a first-in-human clinical trial showed that SCG101 demonstrated promising antiviral and antitumor activities in patients with HBV-related advanced hepatocellular carcinoma (HCC). In six patients with advanced HBV-HCC who received a single IV dose of SCG101 at 5.0 × 107 ~1.0×108 TCR+ T cells/kg, 2 of 6 patients (33%) achieved partial responses (PR) and 2 of 6 patients had stable disease (SD) with observed tumor reduction.
Tumor responses were strongly correlated with the antiviral activities of SCG101. As of data cutoff, 6 of 6 (100%) patients experienced a serum HBsAg reduction and 4 of 6 (67%) patients achieved a 1-3 log reduction after SCG101 infusion. The HBsAg level remained ≤20 IU/mL throughout the follow-up period up to 90 weeks. Tumor reduction was observed in the 4 patients with serum HBsAg reduction > 1 log, and median progression-free survival (PFS) was prolonged (25.8 versus 3.1 weeks) in patients with reduction in HBsAg > 1 log compared to those without progression.
Safety analysis revealed that SCG101 was generally well tolerated, with no reports of serious adverse events or immune effector cell-associated neurotoxicity syndrome. The most common treatment-related adverse events were transient liver enzyme assessment, cytokine release syndrome (CRS), and fever, expected due to the mechanism of clearance of diseased hepatocytes and immune activation of SCG101.
HBV infection is a leading cause of liver cancer and accounts for 50–80% of hepatocellular carcinoma cases worldwide.[1] HBV DNA integrates into the host genome and leads to genetic instability of the host cell and epigenetic remodeling of host DNA, resulting in abnormal expression of HBV oncogenes and antigens .[2] SCG101 can specifically target an HBV peptide presented on HBV-HCC tumor cells, HBV DNA-integrated precancerous hepatocytes, and HBV-infected cells, triggering cytolytic and non-cytolytic mechanisms to eliminate tumor cells and cells. infected with HBV.
“We are excited to be the first to demonstrate the potential of HBV TCR cell therapy to achieve promising tumor responses in solid tumors and induce durable antiviral activities. This unique dual function of SCG101 offers a new approach to treat HBV-associated HCC by targeting the underlying cause of the cancer,” said Frank Wang, CEO of SCG Cell Therapy. “We believe that our GianTTM The TCR discovery platform has the potential to address a broad range of infection-associated cancers, such as Epstein-Barr virus (EBV), human papillomavirus (HPV), and “ultimately establish a new paradigm in the immune treatment of cancer”.
About the SCG101
SCG101, an autologous T cell receptor (TCR) T cell therapy, is an investigational cell therapy product targeting a specific epitope of hepatitis B surface antigen (HBsAg). Using SCG’s exclusive GianTTM Using this technology, high affinity and high avidity natural TCRs can be identified against intracellular antigens presented through the major histocompatibility complex (MHC) in solid tumors. Preclinical and clinical studies of SCG101 demonstrated tumor inhibition and eradication of HBV cccDNA. SCG101 has received clinical trial approval from the US Food and Drug Administration (FDA), China National Medical Products Administration (NMPA), Singapore Health Science Authority (HSA) and Ministry of Health of Hong Kong (DOH) for patients with HBV-related HCC. 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 were more than 905,000 new cases of liver cancer and more than 830,100 deaths from the disease worldwide in 2020, making it one of the leading causes of cancer deaths in the world. world.[3] Chronic HBV infection accounts for at least 50% of HCC cases worldwide.[1] HCC is usually diagnosed at an advanced stage and is associated with 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 against infections and related cancers. The company targets the most common cancer infections: Helicobacter pylori, HPV, HBV and EBV, and is developing a broad and unique portfolio of T cell therapies, antibodies and therapeutic infection vaccines to prevent and cure related cancers. Created and based in SingaporeSCG combines regional assets in Singapore, China And Germany, covering the entire value chain from research and discovery of innovative drugs, manufacturing, clinical development and commercialization. For more information about SCG, please visit us at www.scgcell.com.
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[1] Yes, Xie. (2017). Hepatocellular carcinoma associated with hepatitis B virus. Advances in experimental medicine and biology. |
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[2] Jiang, Y., Han, Q., Zhao, H., Zhang, J. (May 20, 2021). Mechanisms of HBV-induced hepatocellular carcinoma. Journal of Hepatocellular Carcinoma. |
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[3] Liver cancer statistics: World Cancer Research Fund International. WCRF International. (2022, April 14). |
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[4] Golabi P, Fazel S, Otgonsuren M, Sayiner M, Locklear CT, Younossi ZM. (2017). Assessment of mortality in patients with hepatocellular carcinoma according to underlying disease and treatment modalities. |
SOURCE SCG
