SINGAPORE

新加坡

,

，

May 7, 2025

2025年5月7日

/PRNewswire/ -- SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company pioneering TCR T cell therapy for infectious diseases and associated cancers, today announced late-breaking clinical data from its Phase 1 trial evaluating SCG101, autologous HBV-specific TCR-T cell therapy, in patients with advanced HBV-related hepatocellular carcinoma (HCC).

/PRNewswire/ -- SCG Cell Therapy Pte Ltd（SCG），一家专注于感染性疾病和相关癌症TCR T细胞疗法的临床阶段生物技术公司，今日宣布了其1期临床试验的最新突破性数据，该试验评估了自体HBV特异性TCR-T细胞疗法SCG101在晚期HBV相关肝细胞癌（HCC）患者中的疗效。

These data were presented at the European Association for the Study of the Liver (EASL) Congress 2025..

这些数据在2025年欧洲肝病研究协会（EASL）大会上发布。

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.

结果表明，SCG101 在既往接受过重度治疗的 HBV 相关 HCC 患者中，能够持续清除血清乙型肝炎表面抗原 (HBsAg) 和 HBV-DNA。值得注意的是，94% 的患者曾接受过核苷类似物 (NA) 抗病毒治疗，72% 的患者在基线时已出现肝硬化。

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..

单次输注SCG101后，所有接受治疗的患者血清HBsAg均迅速下降，其中94%（16/17）的患者在28天内实现了1.0–4.6 log₁₀的降低，并持续低于100 IU/mL长达1年。值得注意的是，4名患者（23.5%）实现了HBsAg的清除。

In addition to its antiviral effects, SCG101 demonstrated encouraging antitumor activity. All patients had received at least 2 prior lines of systemic cancer treatment, including immune checkpoint inhibitors. Despite this heavily pre-treated population, 8 out of 17 patients (47%) showed measurable tumour regression.

除了其抗病毒效果外，SCG101还展示了令人鼓舞的抗肿瘤活性。所有患者都曾接受过至少2线先前的系统性癌症治疗，包括免疫检查点抑制剂。尽管这一群体经过了多轮治疗，17名患者中有8名（47%）显示出可测量的肿瘤缩小。

At the time of data cutoff, median overall survival (OS) had not yet been reached..

截至数据截止时，尚未达到中位总生存期（OS）。

SCG101 was generally well tolerated, with a good safety profile. Transient alanine aminotransferase (ALT) elevation, consistent with the cytolytic mechanism of SCG101, was observed in 94% of patients and resolved within 14 days. Other common treatment-related adverse events (TRAEs) included cytokine release syndrome (CRS), neutropenia, and thrombocytopenia—all of which were manageable and reversible..

SCG101总体耐受性良好，安全性表现优异。与SCG101的细胞溶解机制一致，94%的患者出现短暂的丙氨酸氨基转移酶（ALT）升高，且在14天内恢复。其他常见的治疗相关不良事件（TRAE）包括细胞因子释放综合征（CRS）、中性粒细胞减少和血小板减少，所有这些均是可管理且可逆的。

Prof. Dr.

教授博士

Shunda Du

顺达杜

, Chief of Liver Surgery Department, Peking Union Medical College Hospital, said: 'The dual antiviral and antitumor effects observed with SCG101 are highly promising, especially in this heavily pre-treated patient population. The sustained HBsAg clearance and tumour response suggest that SCG101 may offer a novel immunotherapeutic option for patients with HBV-related HCC, addressing an area of significant unmet clinical need'..

北京协和医院肝外科主任表示：“SCG101所展现出的双重抗病毒和抗肿瘤效果非常令人鼓舞，尤其是在这种经过多线治疗的患者群体中。持续的HBsAg清除和肿瘤应答表明，SCG101可能为HBV相关HCC患者提供一种新的免疫治疗选择，满足了临床中显著未满足的需求。”

HBV remains a major global health burden, affecting over 250 million people worldwide. It is a leading cause of liver cancer, responsible for 50%–80% of hepatocellular carcinoma cases globally.

乙型肝炎病毒仍然是全球健康的重大负担，影响着全球超过2.5亿人。它是肝癌的主要病因，全球50%至80%的肝细胞癌病例由其引起。

1

1

Chronic HBV infection leads to the integration of HBV DNA into the host genome, resulting in persistent HBsAg expression, chromosomal instability, and activation of oncogenes, thereby contributing to the development of hepatocellular carcinoma.

慢性HBV感染会导致HBV DNA整合到宿主基因组中，从而引起持续的HBsAg表达、染色体不稳定以及癌基因的激活，进而促进肝细胞癌的发生。

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2

SCG101 is designed to selectively target and eliminate HBV-infected hepatocytes and HCC cells by recognizing specific epitope of HBV surface antigen (HBsAg) presented via the major histocompatibility complex (MHC). By triggering both cytolytic and non-cytolytic mechanisms, SCG101 effectively eliminates HBV-infected hepatocytes as well as premalignant and HBV-HCC cells with HBV-DNA integration.

SCG101旨在通过识别由主要组织相容性复合体（MHC）呈递的乙型肝炎病毒表面抗原（HBsAg）的特定表位，选择性靶向并消除HBV感染的肝细胞和肝癌细胞。通过触发细胞溶解和非细胞溶解机制，SCG101有效清除HBV感染的肝细胞以及携带HBV-DNA整合的癌前细胞和HBV相关肝癌细胞。

.

。

'These positive data mark an important step forward in the development of SCG101 and validate our approach of harnessing precision T cell therapy to target chronic HBV infection and HBV-related liver cancer,' said

“这些积极的数据标志着SCG101开发的重要一步，并验证了我们利用精准T细胞疗法靶向慢性乙型肝炎病毒感染和乙肝相关肝癌的方法。”

Christy Ma

马思颖

, Chief Executive Officer of SCG Cell Therapy. 'SCG101 is the first TCR-T cell therapy to demonstrate both virologic clearance and tumour regression in HBV-related HCC patients. We are encouraged by the data, and we look forward to advancing SCG101 through further clinical development to bring this potentially curative therapy to patients in need.'.

SCG细胞治疗公司的首席执行官表示：“SCG101是首个在HBV相关的HCC患者中显示出病毒清除和肿瘤消退的TCR-T细胞疗法。我们对这些数据感到鼓舞，并期待通过进一步的临床开发推进SCG101，为有需要的患者带来这种潜在的治愈性疗法。”

About SCG101

关于SCG101

SCG101 is an investigational autologous T cell receptor (TCR) T cell therapy designed to selectively target specific epitope of the hepatitis B surface antigen (HBsAg). Powered by SCG's proprietary GianT™ TCR screening platform, which enables the discovery of natural, high-affinity, high-avidity TCRs against intracellular antigens presented via the major histocompatibility complex (MHC).

SCG101是一种研究性的自体T细胞受体（TCR）T细胞疗法，旨在选择性靶向乙型肝炎表面抗原（HBsAg）的特定表位。该疗法依托于SCG公司专有的GianT™ TCR筛选平台，该平台能够发现针对通过主要组织相容性复合体（MHC）呈递的胞内抗原的天然、高亲和力、高avidity的TCRs。

SCG101 delivers precise immune-mediated clearance of infected and malignant cells demonstrating significant tumour inhibition and the eradication of HBV covalently closed circular DNA (cccDNA) in preclinical and clinical studies..

SCG101 在临床前和临床研究中显示出显著的肿瘤抑制作用，并能够精确通过免疫介导清除受感染和恶性细胞，根除乙型肝炎病毒共价闭合环状DNA（cccDNA）。

About Hepatocellular carcinoma

关于肝细胞癌

Hepatocellular carcinoma (HCC) is the most common type of liver cancer. In 2020, it was estimated that over 905,000 new cases of liver cancer were diagnosed, and more than 830,100 deaths occurred globally, making it one of the leading causes of cancer-related mortality.

肝细胞癌 (HCC) 是最常见的肝癌类型。据估计，2020 年全球新诊断的肝癌病例超过 905,000 例，死亡人数超过 830,100 人，成为癌症相关死亡的主要原因之一。

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3

Chronic hepatitis B virus (HBV) infection is responsible for at least 50% of HCC cases worldwide.

慢性乙型肝炎病毒（HBV）感染至少是全球50%的肝细胞癌（HCC）病例的致病因素。

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1

HCC is typically diagnosed at an advanced stage, contributing to a poor prognosis with a five-year survival rate of less than 15%.

肝细胞癌通常在晚期才被诊断出来，导致预后较差，五年生存率不到15%。

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4

About SCG Cell Therapy

关于SCG细胞治疗

SCG Cell Therapy is a leading biotechnology company dedicated to developing novel immunotherapies for infectious diseases and associated cancers. The company focuses on targeting some of the most common cancer-causing infections, including Helicobacter pylori, HPV, HBV, and EBV. SCG is advancing a broad pipeline of TCR-based therapeutics aimed at preventing and curing infection-related cancers.

SCG细胞治疗公司是一家领先的生物技术公司，致力于开发针对传染病和相关癌症的新型免疫疗法。该公司专注于针对一些最常见的致癌感染，包括幽门螺杆菌、HPV、HBV和EBV。SCG正在推进一系列基于TCR的治疗药物，旨在预防和治愈与感染相关的癌症。

Headquartered in .

总部位于 。

Singapore

新加坡

, SCG operates across

，SCG在多个领域开展业务

Singapore

新加坡

,

，

China

中国

, and

，以及

Germany

德国

, leveraging regional strengths to cover the entire value chain, from innovative drug research and discovery to manufacturing, clinical development, and commercialization. For more information, please visit

，利用区域优势覆盖整个价值链，从创新药物研发到制造、临床开发和商业化。欲了解更多信息，请访问

www.scgcell.com

www.scgcell.com

.

。

[1]

[1]

Y, Xie. (2017). Hepatitis B virus-associated hepatocellular carcinoma. Advances in experimental medicine and biology.

谢毅. (2017). 乙型肝炎病毒相关的肝细胞癌. 实验医学与生物学进展.

[2]

[2]

Jiang, Y., Han, Q., Zhao, H., Zhang, J. (2021, May 20). The mechanisms of HBV-induced hepatocellular carcinoma. Journal of hepatocellular carcinoma.

江, Y., 韩, Q., 赵, H., 张, J. (2021年5月20日). 乙型肝炎病毒诱导肝细胞癌的机制. 《肝细胞癌杂志》.

[3]

[3]

Liver cancer statistics: World cancer research fund international. WCRF International. (2022, April 14).

肝癌统计：世界癌症研究基金会国际。WCRF国际。（2022年4月14日）

[4]

[4]

Golabi P, Fazel S, Otgonsuren M, Sayiner M, Locklear CT, Younossi ZM. (2017). Mortality assessment of patients with hepatocellular carcinoma according to underlying disease and treatment modalities.

Golabi P, Fazel S, Otgonsuren M, Sayiner M, Locklear CT, Younossi ZM. (2017). 根据基础疾病和治疗方式评估肝细胞癌患者的死亡率。

SOURCE SCG Cell Therapy Pte Ltd

源SCG细胞治疗私人有限公司

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