SCG101 / SCG Cell Therapy - LARVOL DELTA

SCG Announces Late-Breaking Clinical Data of SCG101 in HBV-Related Hepatocellular Carcinoma Presented at EASL 2025 (PRNewswire) - P1 | N=38 | NCT06617000 | Sponsor: SCG Cell Therapy Pte. Ltd. | "The results demonstrated that SCG101 led to sustained clearance of serum hepatitis B surface antigen (HBsAg) and HBV-DNA in heavily pre-treated patients with HBV-related HCC. Notably, 94% of patients had received prior nucleoside analogue (NA) antiviral therapy, and 72% presented with liver cirrhosis at baseline. Following a single-dose SCG101 infusion, all treated patients experienced a rapid decline in serum HBsAg, with 94% (16/17) achieving a 1.0–4.6 log₁₀ reduction within 28 days and persisting < 100 lU/mL for up to 1 year. Notably, 4 patients (23.5%) achieved HBsAg loss. In addition to its antiviral effects, SCG101 demonstrated encouraging antitumor activity....Despite this heavily pre-treated population, 8 out of 17 patients (47%) showed measurable tumour regression. At the time of data cutoff, median overall survival (OS) had not yet been reached."

Late-breaking abstract • P1 data • Hepatocellular Cancer

SCG101 HBV-specific TCR-T cell therapy demonstrates dual antiviral and antitumor activities, achieving HBV clearance in liver biopsies and functional cure in HBV-related hepatocellular carcinoma patients (EASL 2025) - P1 | "Seventeen patients completed SCG101 infusion at 5 × 107 or 1 × 108 cells/kg intravenously 3 days after lymphodepletion (Cyclophosphamide 500 mg/m²/day, and Fludarabine 25 mg/m²/day). SCG101 achieved HBV clearance serologically and histologically. The rapid, sustained HBsAg reduction and virological clearance of HBV markers in biopsies support SCG101's cytolytic mechanism of HBsAg-targeted immune activation and subsequent elimination of infected hepatocytes and HCC cells. These findings underscore SCG101's potential to achieve a mechanism-driven functional cure for chronic HBV infection and long-term tumor control via its unique dual activities."

Biopsy • Clinical • Late-breaking abstract • Hematological Disorders • Hepatitis B • Hepatocellular Cancer • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • HLA-A • STMN2

SCG101 TCR-T Therapy Achieves Rapid and Sustained HBsAg Reduction with >30% HBsAg Loss in HBV-Related Hepatocellular Carcinoma Patients (APASL 2025) - P1 | "SCG101 demonstrated a rapid and sustained serum HBsAg reduction in advanced HBV-HCC patients that can be attributed to its cytolytic activity targeting hepatocytes and HCC cells with integrated HBV-DNA. The sustained reduction in HBsAg, along with the >30% HBsAg loss observed in this difficult-to-treat population, demonstrates SCG101's potential to be a curative treatment option for chronic HBV infection. Table and Figure:Figure 1."

Clinical • IO biomarker • Acute Kidney Injury • Fibrosis • Gastroenterology • Hematological Disorders • Hepatitis B • Hepatocellular Cancer • Hepatology • Immunology • Liver Cirrhosis • Nephrology • Oncology • Renal Disease • Solid Tumor • HLA-A • STMN2

SCG Cell Therapy Presents Promising Phase 1 Data for a Novel HBV-Specific TCR-T Therapy (SCG101) at the AASLD Liver Meeting 2024 (PRNewswire) - P1 | N=38 | NCT06617000 | Sponsor: SCG Cell Therapy Pte. Ltd. | "SCG Cell Therapy Pte Ltd...announced late-breaking data from its Phase 1 trial of SCG101....In the Phase 1 clinical trial, SCG101 exhibited promising antiviral activity in patients with advanced HBV-related hepatocellular carcinoma (HBV-HCC). Among the 12 patients treated with a single intravenous dose of SCG101 at 5.0×107 ~ 1.0×108 TCR+ T cells/kg, all patients demonstrated a significant reduction in serum HBsAg levels, with 11 out of 12 (92%) patients achieving a reduction of 1.0 to 4.6 log10, and the levels remaining below 100 IU/mL throughout the follow-up period of up to one year. Notably, four patients (33%) experienced HBsAg loss within 21 days following a single infusion of SCG101 and which persisted throughout the follow-up. The safety profile of SCG101 was generally favourable, with the therapy being well tolerated."

P1 data • Hepatocellular Cancer

A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related (clinicaltrials.gov) - P1 | N=38 | Recruiting | Sponsor: SCG Cell Therapy Pte. Ltd.

New P1 trial • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Oncology • Solid Tumor • STMN2

First-in-human clinical result of a novel HBV-specific TCR T cell therapy (SCG101) in patients with HBV-related hepatocellular carcinoma (HCC) (EASL-ILC 2024) - "SCG101, as a monotherapy for patients with HBV-related HCC, demonstrated antiviral and antitumor activities alongside a survival benefit and manageable safety profile. The persistence of SCG101, reduction of serum HBsAg, and tumor response collectively underscore its on-target activity. A phase II trial to evaluate the safety and efficacy of SCG101 in HLA-A*02: 01(+) patients with HBV-related HCC will be initiated."

Clinical • Late-breaking abstract • P1 data • Gastrointestinal Cancer • Hematological Disorders • Hepatitis B • Hepatocellular Cancer • Oncology • Solid Tumor • HLA-A • STMN2

EASL Wrap-up Session Highlighted Late-Breaking Clinical Data of First-in-class HBV-specific TCR T Cell Therapy (SCG101) Showing Improved Overall Survival in HBV-related Hepatocellular Carcinoma (PRNewswire) - P1 | N=36 | NCT05339321 | "Results from the first-in-human clinical trial showed that SCG101 exhibited promising antiviral and antitumor dual activities in patients with advanced HBV-related hepatocellular carcinoma (HCC). In six patients with advanced HBV-HCC who received SCG101 at 5.0×107 ~ 1.0×108 TCR+ T cells/kg, the objective response rate (ORR) is 33%....As of the data cutoff, 4 out of 6 patients (67%) achieved serum HBsAg reduction of 1~4 log10 after single SCG101 infusion. The HBsAg level maintained ≤15 IU/mL throughout the follow up period for up to 27 months. Tumor reduction was observed in all patients with serum HBsAg reduction ≥1 log10, and the median progression free survival (PFS) and overall survival (OS) were prolonged (mPFS: 5.9 vs 0.7 months, mOS:19.0 vs 6.3 months) in patients with HBsAg reduction ≥1 log than in those without."

Late-breaking abstract • P1 data • Hepatitis B • Hepatocellular Cancer

Genetically redirected HBV-specific T cells target HBsAg-positive hepatocytes and primary lesions in HBV-associated HCC. (PubMed, Clin Mol Hepatol) - P1 | "Transferred T cells expanded, developed a stem cell-like memory phenotype, and were still detectable after six months in the patient's blood. SCG101 T-cell therapy showed encouraging efficacy and safety in pre-clinical models and in a patient with primary HBV-HCC and concomitant chronic hepatitis B with the capability to eliminate HBsAg+ cells and achieve sustained tumor control after single dosing."

Journal • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Liver Cancer • Oncology • Solid Tumor • STMN2

SCG Cell Therapy Announces Late-Breaking Clinical Data at AASLD Showing SCG101 Improved Tumor Reponses and Achieved Sustained Antiviral Activates in Patients with Advanced HBV-related Hepatocellular Carcinoma (PRNewswire) - P1 | N=36 | NCT05339321 | "Results from a first-in-human clinical trial showed that SCG101 demonstrated promising antiviral and antitumor activities in patients with advanced HBV-related hepatocellular carcinoma (HCC). In six patients with advanced HBV-HCC who received a single IV dose of SCG101 at 5.0×10⁷ ~ 1.0×10⁸ TCR+ T cells/kg, 2 out of 6 (33%) patients achieved partial responses (PR) and 2 of 6 patients had stable diseases (SD) with tumor reduction observed. The tumor responses were highly correlated with the antiviral activities of SCG101....The safety analysis revealed that SCG101 was generally well tolerated with no cases of serious adverse events or immune effector cell-associated neurotoxicity syndrome. "

P1 data • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

ANTIVIRAL AND ANTITUMOR EFFECT OF NOVEL HBsAg-SPECIFIC TCR T CELL THERAPY (SCG101) IN PATIENTS WITH HBV-RELATED HEPATOCELLULAR CARCINOMA (AASLD 2023) - "All subjects received a single dose of 5x10e7 or 1x10e8 cells/kg of SCG101 TCR-T cells intravenously after lymphodepletion with cyclophosphamidefludarabine. SCG101, as a single agent, demonstrated significant antiviral and antitumor activity in subjects with HBV-related HCC. The persistence of TCR T cells, reduction of serum HBsAg, and tumor response proved on-target activity of SCG101. A phase I/II clinical trial to systematically evaluate the safety and efficacy of SCG101 has been initiated."

Clinical • IO biomarker • Late-breaking abstract • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Oncology • Solid Tumor • HLA-A • STMN2

First-in-human trial of novel HBsAg-specific TCR T cell therapy (SCG101) in patients with HBV-related hepatocellular carcinoma (SITC 2023) - "The persistence of TCR+ T cells, reduction of serum HBsAg, and tumor response are strongly correlated with the mechanism of action of SCG101. A phase I/II clinical trial to further evaluate the safety and efficacy of SCG101 is ongoing."

Clinical • P1 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • HLA-A • STMN2

Autologous cytotoxic T-cell receptor T cell therapy (SCG101) against hepatitis B surface antigen phase I/II trial for patients with advanced hepatitis B-related hepatocellular carcinoma. (ASCO 2023) - P1, P1/2 | "Autologous SCG101 T cell therapy may provide a new treatment option for patients with advanced Hepatitis B virus-related HCC. Clinical trial information: NCT05417932."

Clinical • Metastases • P1/2 data • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Oncology • Solid Tumor • Transplantation • HLA-A • STMN2

ISCT 2023: Late-breaking SCG101 Data Show 100% HBsAg+ Hepatocyte Eradication and 74.5% HCC Tumour Reduction With Single Dose HBsAg-specific TCR-T Cell Therapy (PRNewswire) - P=NA | N=NA | "SCG Cell Therapy Pte Ltd (SCG)...presented late-breaking data from its first-in-class autologous HBsAg-specific T-Cell receptor-engineered T Cell (TCR-T) Therapy - SCG101 - at the International Society for Cell & Gene Therapy (ISCT) conference in Paris, France. SCG101 showed significant antitumor activities with a tumour reduction of 74.5% per mRECIST after single dose SCG101 monotherapy treatment. A durable tumour response of >6.9 months was reported by data cut-off. Pre-treatment and post-treatment biopsies showed 100% eradication of HBsAg+ hepatocytes in the liver. Serum HBsAg reduced from 557.96 IU/mL at baseline to 1.3 IU/mL on Day 7 and further reduced to 0.08 IU/mL (3.83 log reduction) by Day 28 after SCG101 infusion."

Clinical data • Late-breaking abstract • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

SCG Cell Therapy to Present Late-Breaking Data at the International Society for Cell & Gene Therapy (ISCT) Highlighting Promising Antitumor and Antiviral Activities of SCG101 in Treating HBV-Related Hepatocellular Carcinoma (PRNewswire) - P=NA | N=NA | "Singapore based SCG Cell Therapy Pte Ltd (SCG)...announced that late-breaking data from the company's TCR-T therapy pipeline - SCG101, will be presented at the International Society for Cell & Gene Therapy (ISCT) in Paris, France on 1 June....The late-breaking data to be presented at ISCT demonstrated positive efficacy of SCG101 as a monotherapy in patients with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC), achieving partial response (PR) after a single dose of SCG101 with durable tumour response observed. Serum HBsAg significantly decreased and the expression of HBsAg in hepatocyte dropped to undetectable."

Clinical data • Late-breaking abstract • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Enhanced anti-tumor activity of HBsAg specific TCR-T (SCG101) in hepatitis B virus (HBV) related hepatocellular carcinoma (HCC) by preventing T cell exhaustion through PD-1/PD-L1 axis blockade (SITC 2022) - "In vivo, anti-tumor activities were evaluated in HBsAg + PD-L1 + HepG2 cell xenograft mice by i.v. infusing pre-exhausted PD-1 + SCG101 with and without PD-1 (Pembrolizumab) or PD-L1 (Atezolizumab) inhibitors. Procedures used in this study were approved by the Institutional Animal Care and Use Committee (IACUC) at WuXi AppTec (Nantong) Co., Ltd. IACUC serial number: ON01-QD009-2020."

IO biomarker • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • CD4 • CD8 • HLA-A • STMN2

TCR-T: A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma (clinicaltrials.gov) - P1/2 | N=46 | Recruiting | Sponsor: SCG Cell Therapy Pte. Ltd. | Initiation date: Jul 2022 ➔ Oct 2022

Trial initiation date • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Oncology • Solid Tumor • STMN2

TCR-T: A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma (clinicaltrials.gov) - P1/2 | N=46 | Recruiting | Sponsor: SCG Cell Therapy Pte. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Oncology • Solid Tumor • STMN2

SCG Cell Therapy Announces U.S FDA Clearance of Investigational New Drug Application for SCG101, SCG's Novel TCR-T Cell Therapy For Hepatitis B-related Liver Cancers (PRNewswire) - "Singapore-based SCG Cell Therapy Pte Ltd ('SCG') announced that U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for SCG101, an investigational T-cell receptor (TCR) T cell therapy for patients with hepatitis B virus (HBV) related liver cancer. This clearance initiates the advancement of SCG101 Phase 1/2 clinical trials globally....This announcement follows SCG's previous IND approvals from China National Medical Products Administration (NMPA) in March 2022 and Singapore Health Sciences Authority (HSA) in May 2022."

IND • New P1/2 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Antiviral and antitumor activity of SCG101, an autologous HBV-specific T cell receptor engineered T cell (TCR-T) therapy in HBV-related advanced hepatocellular carcinoma (HCC) patients after receiving ≥ 2 prior lines of systemic therapies (EASL-ILC 2022) - "Prior to intravenous infusion of SCG101, patients receive lymphodepleting chemotherapy (fludarabine 25 mg/m2/day and cyclophosphamide 500 mg/m2/day for 3 consecutive days. Systemic SCG101 TCR-T cell therapy was well tolerated and showed promising early signs of clinical efficacy in advanced HBV-related HCC patients who have exhausted available targeted and immunotherapy options. Early and sustained HBsAg reduction demonstrates encouraging antiviral activity with target engagement of SCG101 and might serve as a potential predictive marker of antitumor efficacy. Preliminary data support further systematic clinical evaluation."

Clinical • IO biomarker • Gastrointestinal Cancer • Hepatocellular Cancer • Inflammation • Oncology • Solid Tumor • HLA-A • STMN2

SCG Cell Therapy Presents Clinical Proof-of-Concept Data at International Liver Congress (ILC) 2022 Annual Meeting (PRNewswire) - P1/2 | N=46 | NCT05417932 | Sponsor:SCG Cell Therapy Pte. Ltd. | "Singapore-based SCG Cell Therapy Pte Ltd ('SCG') today announced interim data from an investigator-initiated clinical trial of SCG101, which included data evaluating single dose SCG101 in patients with advanced hepatitis B (HBV) related hepatocellular carcinoma (HCC)....In the three HLA-A*02:01-positive patients with advanced HBV-related HCC who had received at least two prior cancer therapies, the tumour growth was controlled in two out of three patients with lesion shrinkage observed. In addition, there is rapid and significant serum HBsAg reduction observed in both subjects from a baseline of 1,004.3 IU/mL and 521.6IU/ML to 23.8 IU/mL and 9.1 IU/mL in just 28 days from SCG101 treatment and further reduced to 14.0 IU/m and 0.3 IU/mL within 60 days from treatment."

P1/2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology

TCR-T: A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma (clinicaltrials.gov) - P1/2 | N=46 | Not yet recruiting | Sponsor: SCG Cell Therapy Pte. Ltd.

New P1/2 trial • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Oncology • Solid Tumor • STMN2

Autologous HBV-specific T Cell Receptor Engineered T Cells (TCR-T) in Patients With HBV-related Advanced HCC (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Peking Union Medical College Hospital

New P1 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • STMN2

NMPA Clears IND for First T-Cell Receptor (TCR) T Cell Therapy to Treat Hepatitis B virus (HBV) associated hepatocellular carcinoma (HCC) (Yahoo Finance) - "Singapore-based SCG Cell Therapy Pte Ltd...today announced that the China National Medical Products Administration (NMPA) has cleared its Investigational New Drug (IND) application for SCG101, the company's first T-cell receptor T-cell therapy targeted hepatitis B viral antigens. SCG101 is the first TCR-T cell therapy approved by the NMPA for the treatment of hepatocellular carcinoma."

Non-US regulatory • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor