Home SCG101 Demonstrates Dual Anti-Viral and Anti-Tumor Efficacy in Late-Breaking Clinical Data Presented at EASL 2025

SCG101 Demonstrates Dual Anti-Viral and Anti-Tumor Efficacy in Late-Breaking Clinical Data Presented at EASL 2025

May 08, 2025 10:32 CST Updated 10:32
SCG Cell Therapy

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Today (May 8th),SCG SCIENCE (DALIAN) CO., LTD announced that the companyHBV-specific TCR-T Cell Therapy- SCG101 Featured Again in Latest Breakthrough (Late-breaking) Clinical Research at the 2025 European Association for the Study of the Liver (EASL 2025) Annual Meeting in Amsterdam, Netherlands. The latest data from this clinical trial shows,SCG101 Demonstrates Dual Antiviral and Antitumor Effects in Treating Advanced HBV-Related Hepatocellular Carcinoma (HCC) Patients

According to the disclosed information, all 17 patients experienced a rapid "precipitous" decline in serum hepatitis B surface antigen (HBsAg) after receiving a single infusion of SCG101, among which...Up to 94% of patients achieved a reduction of 1.0–4.6 log₁₀ within 28 days, and during the follow-up period of up to one year, patients' HBsAg levels remained consistently below 100 IU/mL.. Particularly noteworthy is that, among themFour patients (approximately 23.5%) achieved complete HBsAg clearance within 21 days after treatment and remained in a cleared state throughout the follow-up period.

Hepatitis B remains a major global public health challenge and the leading cause of liver cancer. Chronic hepatitis B infection leads to the integration of HBV viral DNA into the host genome, causing continuous expression of HBsAg, disrupting chromosomal stability, activating oncogenes, and subsequently leading to the occurrence and development of hepatocellular carcinoma.
SCG101 is a TCR-T cell therapy with autologous T-cell receptors specifically targeting the hepatitis B surface antigen (HBsAg). This productBy identifying HBV-specific epitopes presented by the major histocompatibility complex (MHC), precise targeting and clearance of HBV-infected cells can be achieved.With its unique immune mechanism, this product not only efficiently clears HBV-infected liver cells but also precisely targets and eliminates precancerous lesion cells and liver cancer cells with HBV-DNA integration, comprehensively blocking the pathological process of HBV-related liver cancer from the source of viral infection to key stages of tumor development.
In addition to its breakthrough antiviral efficacy, SCG101 also demonstrated significant antitumor activity. All participants in the study wereEnd-stage liver cancer patients, and have failed existing standard systemic cancer treatments (including immune checkpoint inhibitor therapy), with a lack of effective treatment options. After a single infusion of SCG101,Up to 47% of patients achieved tumor regression.As of the data cutoff, the median overall survival (OS) of the patients is still under continued follow-up, with the median follow-up period already exceeding 10.6 months. Compared to the current median OS of end-stage liver cancer patients, which generally does not exceed 6 months, SCG101 therapy has the potential to bring long-term survival benefits to patients with advanced liver cancer.

SCG SCIENCE (DALIAN) CO., LTD's press release stated that SCG101 has demonstrated inspiring dual antiviral and antitumor efficacy in heavily pretreated patients. The sustained clearance of hepatitis B surface antigen (HBsAg) and tumor response not only confirm the effectiveness of this therapy but also imply that SCG101 holds promise to open up a novel multidimensional immunotherapy pathway for patients with HBV-related hepatocellular carcinoma.
References:
[1] EASL Highlights! SCG101 Phase I Clinical Trial Demonstrates Dual Effects of HBV Clearance and Tumor Regression..Retrieved May 8,2025. From https://www.prnasia.com/story/488159-1.shtml

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