AASLD Late-Breaking Study: SCG101, the World’s First HBV-Specific TCR-T Cell Therapy, Demonstrates Durable Antiviral Response and Effective Tumor Regression in Advanced Hepatocellular Carcinoma

SingaporeNovember 14, 2023/PR Newswire/ --November 14,The Annual Meeting of the American Association for the Study of Liver Diseases (AASLD – The Liver Meeting) held in Boston, USAUpSCG101, the HBV-specific TCR-T cell therapy developed by SCG SCIENCE (DALIAN) CO., LTD, has been selected for the latest Late-breaking clinical research. The study shows that SCG101 demonstrated significant antiviral and antitumor activity in treating patients with advanced hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) and significantly prolonged the progression-free survival of the patients.

According to the published content, six patients with advanced HBV-related hepatocellular carcinoma received a single dose of 5.0×10.⁷～1.0×10⁸/kg TCR+ T cell infusion, where 2 patients achieved partial response (PR) – with 1 patient achieving pathological complete response (pCR) in liver lesions, and the other 2 patients having stable disease (SD) with observed tumor shrinkage.

Research analysis shows that the tumor response in patients is highly correlated with the antiviral activity of SCG101. All patients (100%) who received SCG01 treatment exhibited a decrease in serum HBsAg, with four patients showing a significant reduction of 1-3 log in serum HBsAg, which remained at low levels for up to 90 weeks (as of the data cutoff date) without rebound. Additionally, these four patients also demonstrated tumor shrinkage and a significantly prolonged progression-free survival (PFS) of 25.8 weeks (as of the data cutoff date).

Dr. Du Shunda, Director of the Liver Surgery Department at Peking Union Medical College Hospital, stated: "China is a major country for liver cancer. Unlike in Europe and the United States, HBV infection is the leading cause of liver cancer in China. SCG101 targets the pathogenesis of HBV-related liver cancer by activating specific T-cells to target HBV antigens, offering new approaches and directions for precision medicine in liver cancer from its root cause. The preliminary clinical data also brings new hope to a wide range of patients."

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—underlying liver disease and liver cancer—which often influence each other, forming a vicious cycle. In traditional liver cancer treatments, the negative impact of underlying liver disease is often overlooked. The direct cause of death for 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 achieves antiviral effects while treating tumors, preventing HBV reactivation, slowing or reducing the progression and recurrence of liver cancer, and extending patient survival.

Wang Shuli, CEO of SCG SCIENCE (DALIAN) CO., LTD, stated: "SCG SCIENCE 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 thrilled 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 strengthens our confidence in SCG's exclusive, globally leading GianT."^TM"We are confident and have high expectations for the TCR innovative technology platform, which will undoubtedly accelerate the company’s exploration and development of more TCR-T cell therapy products to conquer solid tumors."