SCG101 by Sinocelltech Becomes World’s First TCR-T Therapy Granted IND Approval for Cholangiocarcinoma Treatment

ShanghaiNovember 23, 2023/PR Newswire/ -- According to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, SCG Science（A Singapore-based company dedicated to developing novel immunotherapies for treating infections and their associated cancers.SCG101 Cell Injection Receives Clinical Trial Approval from China's National Medical Products Administration, as the World’s First Cell Therapy for Biliary Tract Cancer。

SCG101 Injection is a global first-in-class TCR-T cell therapy product targeting hepatitis B surface antigen-specific autologous cells. This therapy received clinical trial approvals from the China National Medical Products Administration (NMPA), the U.S. Food and Drug Administration (FDA), the Health Sciences Authority (HSA) of Singapore, and the Department of Health (DOH) of Hong Kong between 2022 and 2023 for the treatment of hepatitis B virus (HBV)-related hepatocellular carcinoma. The current approval further expands the indications of SCG101 to include HBV-related intrahepatic cholangiocarcinoma.

Intrahepatic Cholangiocarcinoma (ICC)The onset is insidious, with a high degree of malignancy and a lack of effective treatment methods.Its incidence rate has shown an increasing trend year by year in recent years, especially with a high incidence in Asian countries. Chinese patients account for 55% of the global patient population.^[1]。Research shows,More than 50% of intrahepatic cholangiocarcinoma cases are associated with HBV.InfectionRelated^[2]。

According to the SCG101 clinical study, SCG101 demonstrated efficacy in treating patients with advanced HBV-related hepatocellular carcinoma (HCC).Significant antiviral and antitumor activity, and significantly extended progression-free survival in patients.The study was selected as a latest breakthrough research by the American Association for the Study of Liver Diseases (AASLD) in November 2023. According to the disclosed content, six patients with advanced HBV-related hepatocellular carcinoma received a single infusion of SCG101 cells, with two patients achieving partial response (PR) – one of whom achieved pathological complete response (pCR) in liver lesions, while another two patients had stable disease (SD) with observed tumor shrinkage. Analysis of the study indicated that the tumor response was highly correlated with the antiviral activity of SCG101. All patients (100%) who received SCG101 treatment showed a decrease in serum HBsAg; among them, four patients exhibited 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. Meanwhile, all four patients experienced tumor shrinkage and a significantly prolonged progression-free survival (PFS) of 25.8 weeks (as of the data cutoff date).

SCG SCIENCE (DALIAN) CO., LTD CEO Wang Shuli stated: "The SCG101 cell therapy has demonstrated very promising anti-tumor efficacy and sustained antiviral response in liver cancer clinical research, laying a solid foundation for the expansion of the product's indications. We are delighted that SCG101 has been approved by the National Medical Products Administration to conduct a Phase 1/2a clinical trial for intrahepatic cholangiocarcinoma, making it the world's first cell therapy product targeting intrahepatic cholangiocarcinoma."Continuous Innovation and BreakthroughsWill undoubtedly bring more benefits and hope to patients. We look forward to achieving this through the company's independently innovated GianT.^TMTCR technology platform, to develop more TCR-T cell therapy products and play a greater role in the fight against solid tumors."