Recently, at the AASLD Liver Meeting held in San Diego, USA, SCG SCIENCE (DALIAN) CO., LTD (SCG) announced the latest breakthrough Phase I clinical research data of SCG101, the world's first TCR-T cell therapy product targeting hepatitis B surface antigen (HBsAg) with specificity, causing widespread attention and a stir in the medical community.Following its selection as a Late-Breaking Study at AASLD 2023, SCG101 has once again been featured in the AASLD 2024 Late-Breaking Studies. The latest data focuses on SCG101's sustained anti-HBV viral efficacy in Phase I clinical trials.According to the published research data, a single infusion of SCG101 demonstrated astonishing results. In 12 difficult-to-treat patients with varying degrees of liver cirrhosis who received a single TCR-T cell infusion, all patients experienced a rapid and dramatic decline in serum HBsAg. Up to 92% of the patients exhibited significant antiviral activity, and their HBsAg levels remained consistently low during a one-year follow-up period, meeting the criteria for treatment cessation. Among them, four patients (one-third) achieved HBsAg clearance within 21 days after a single dose, showing quick and significant efficacy that was sustained throughout the follow-up period, maintaining a cleared state without recurrence. The root cause of the viral infection was eliminated, achieving fundamental and complete eradication without rebound, reaching an impressive and remarkable therapeutic effect. A single treatment achieved a true functional cure for hepatitis B.As is well known, despite the current availability of treatments such as nucleoside analogs and interferons, these therapies primarily delay disease progression by inhibiting HBV replication. They are unable to effectively eliminate the virus or reverse the immune tolerance state induced by the virus. The vast majority of patients require long-term, even lifelong, treatment. Even so, these treatments cannot fundamentally block the occurrence of liver cancer. Currently, drugs under research for hepatitis B treatment, such as small molecule inhibitors and small nucleic acid drugs, can suppress viral activity or reduce HBsAg levels to a certain extent. However, they cannot directly target and eliminate the root cause of persistent infection. After discontinuation of the drugs, viral recurrence and indicator rebound remain common challenges and dilemmas. Even with long-term treatment, true functional cure in the full sense cannot be achieved.In China, there are approximately 100 million hepatitis B patients. Among the more than 400,000 new liver cancer cases each year, hepatocellular carcinoma (HCC) caused by hepatitis B virus (HBV) infection accounts for 83.7%, posing a significant threat. Against this backdrop, the breakthrough data on hepatitis B clearance from SCG SCIENCE (DALIAN) CO., LTD (SCG) has surpassed the critical indicators and "gold standard" for the development of new hepatitis B drugs, representing a major breakthrough in the treatment field and bringing hope of a cure to many hepatitis B patients.SCG utilizes its proprietary GianTCR™ technology platform to screen for high-affinity, high-activity natural T-cell receptors (TCRs) that can effectively target HBV antigen epitopes presented by major histocompatibility complex (MHC) on HBV-infected cells and HBV-related hepatocellular carcinoma cells. This triggers a TCR-mediated specific T-cell immune targeting mechanism, effectively eliminating cccDNA, HBV DNA-integrated hepatocytes, and HBV-HCC tumor cells, offering a new therapeutic strategy for the complete eradication of HBV.
Dr. Ke Zhang, Chief Scientific Officer of SCG, stated:"SCG101 Phase I Clinical Study Achieves Breakthrough Results, Marking an Important Milestone in the Development of SCG101 as the World's First TCR-T Cell Therapy Product Targeting HBV. The excellent safety profile demonstrated in advanced refractory patient populations, along with its efficacy in completely eliminating the viral source and precisely achieving true functional cure, is highly encouraging. We will continue to fully advance the clinical development and indication expansion of SCG101, committed to providing patients with a novel curative therapy. Meanwhile, the unique GianTCR™ technology platform independently developed by SCG SCIENCE (DALIAN) CO., LTD is also showing greater potential, further driving innovative breakthroughs in immune cell therapies targeting chronic infections such as human papillomavirus (HPV) and Epstein-Barr virus (EBV), as well as related solid tumors."SCG101 is a type of autologous T-cell receptor TCR-T cell therapy specifically targeting the hepatitis B surface antigen (HBsAg). SCG SCIENCE utilizes its proprietary GianTCR™ technology platform to screen for high-affinity, highly active natural TCRs, which can effectively target intracellular antigens expressed through major histocompatibility complex (MHC) in solid tumors. Preclinical and clinical research data show that SCG101 has tumor suppression and HBV cccDNA eradication effects, enabling both anti-tumor and antiviral functions. 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 clinical trials related to hepatitis B virus-associated advanced hepatocellular carcinoma. Currently, Phase I/II clinical trials of SCG101 are underway (NCT05417932).SCG (Stellar BioPharma) is a leading biotechnology company focused on developing novel immunotherapies for infections and their associated cancers. The company is developing a broad and unique range of TCR-T cell therapies targeting the most common cancer-causing infections: Helicobacter pylori, human papillomavirus, and hepatitis B, with the goal of preventing and curing infections and their related cancers. Headquartered in Singapore, with its R&D center located at the IZB Innovation Center in Munich, Germany, SCG leverages regional advantages across Singapore, China, and Germany, covering the complete industry value chain from innovative drug discovery, manufacturing, clinical trials, to commercialization. For more information about SCG, please visit www.scgcell.com.Copyright © 2024 PHARMCUBE. All Rights Reserved.
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