▎WuXi AppTec Content Team Report

November 14,SCG announces,At the American Association for the Study of Liver Diseases Annual Meeting (AASLD – The Liver Meeting) held in Boston, USA, the company'sHepatitis B Virus (HBV)Specific TCR-T Cell TherapySCG101 Selected for Latest Breakthrough (Late-breaking) Clinical Research. The study demonstrated that SCG101 exhibited significant antiviral and antitumor activity in treating patients with advanced HBV-related hepatocellular carcinoma (HCC) and significantly extended progression-free survival.

SCG101 is aAutologous T-cell receptor (TCR)-T cell therapy specific for hepatitis B surface antigenSCG relies on its self-developed GianT technology platform to screen for natural TCRs with high affinity and high activity.Can effectively target intracellular antigens expressed through the major histocompatibility complex (MHC) in solid tumors.Preclinical and clinical research data show that SCG101 has tumor suppression and HBV cccDNA eradication effects, achieving both anti-tumor and antiviral functions. SCG101 has been approved for clinical trials related to hepatitis B infection-associated liver cancer in the United States, China, Singapore, and other regions.

According to this inAASLD Annual MeetingThe published content states that six patients with advanced HBV-related hepatocellular carcinoma received a single dose of 5.0×.10⁷～1.0×10⁸/kg TCR+ T cell infusion, inTwo patients achieved partial response (PR).In China, one patient with liver lesions achieved pathological complete response (pCR), and anotherTwo patients had stable disease (SD) with tumor shrinkage observed.。

The research analysis shows that the tumor response in patients is highly correlated with the antiviral activity of SCG101. In the studyAll patients (100%) who received SCG01 treatment showed a decline in serum HBsAg. Among them, four patients experienced a significant reduction of 1-3 logs in serum HBsAg, which remained at low levels for up to 90 weeks (as of the data cutoff date)., no rebound. At the same time,Tumor shrinkage was observed in all four patients, with a significant extension of progression-free survival (PFS) to 25.8 weeks (as of the data cutoff date).。

Hepatitis B virus infection is the main cause of liver cancer in China. Most patients have underlying liver diseases such as hepatitis, cirrhosis, and abnormal liver function. Therefore, in the same patient, at the same time, and in the same organ, there exist two completely different diseases, namelyBasic Liver Disease and Liver Cancer, often influencing each other and forming a vicious cycle.In traditional liver cancer treatment, the negative impact of underlying liver disease is often overlooked. The direct cause of death in some patients with advanced liver cancer is often not the tumor itself, but rather the accompanying underlying liver disease and its complications [1].Therefore,SCG101 can achieve antiviral effects while treating tumors, preventing HBV reactivation, delaying or reducing the progression and recurrence of liver cancer, and extending patient survival.。

Director of the Department of Hepatic Surgery, Peking Union Medical College HospitalDirector DusundaIt was noted that China is a country with a high incidence of liver cancer, and HBV infection is the leading cause of liver cancer. SCG101 targets the pathogenesis of HBV-related liver cancer by engaging specific T cells to target HBV antigens.Bringing New Ideas and Directions for Precision Medicine in Liver Cancer from the Root, Preliminary clinical data have also brought new hope to a wide range of patients.

CEO of SCGMr. Shuli WangStated that, SCG is committed to developing novel targeted immunotherapies for viral infections and their associated cancers (such as liver cancer, cervical cancer, and nasopharyngeal cancer). We are very pleased that SCG101 has become the first TCR-T cell therapy targeting the hepatitis B virus, demonstrating significant anti-tumor efficacy and a durable antiviral response in treating liver cancer cases, bringing substantial benefits to patients. The excellent performance of SCG101 also gives them great confidence and higher expectations for the GianT TCR innovative technology platform, which will undoubtedly drive the company to accelerate the exploration and development of more TCR-T cell therapy products aimed at conquering solid tumors.

[2] AASLD Latest Breakthrough Research Results | SCG Cell Therapy Pte. Ltd.'s World's First HBV-Specific TCR-T Cell Therapy Achieves Effective Tumor Response and Durable Antiviral Reaction in Advanced Liver Cancer. Retrieved Nov 14，2023，from https://www.prnasia.com/story/426746-1.shtml