SCG 细胞疗法在 2022 年国际肝病大会 (ILC) 年会上展示临床概念

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SCG 细胞疗法在 2022 年国际肝病大会 (ILC) 年会上展示临床概念验证数据

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美国东部时间 2022 年 6 月 23 日 05:00
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    SCG101的临床试验中期结果显示，在三分之二的晚期 HBV 相关 HCC 患者中观察到肿瘤控制和病灶缩小
    结果显示血清 HBsAg 快速显着降低表明抗病毒活性信号
    提供的数据支持将 SCG101 推进到全球临床试验的 1/2 期

新加坡 2022 年 6 月 23 日 /美通社/ -- 总部位于新加坡的 SCG 细胞疗法私人有限公司（“SCG”）今天公布了一项由研究者发起的 SCG101临床试验的中期数据，其中包括评估单剂量 SCG101治疗晚期肝炎患者的数据B (HBV) 相关肝细胞癌 (HCC)。数据显示三名患者中有两名具有显着的抗病毒活性和肿瘤控制。这组数据于 6 月 23 日在伦敦举行的国际肝病大会 (ILC) 2022 年会上公布。

在三名 HLA-A*02:01 阳性的晚期 HBV 相关 HCC 患者中，他们至少接受过两种癌症治疗，三分之二的观察到病灶缩小的患者的肿瘤生长得到控制。此外，在 SCG101 治疗后的短短 28 天内，两名受试者的血清 HBsAg 从基线 1,004.3 IU/mL 和 521.6IU/mL 快速显着降低至 23.8 IU/mL 和 9.1 IU/mL，并进一步降低至 14.0治疗后 60 天内 IU/m 和 0.3 IU/mL。

“这些数据显示，一种独特的 T 细胞受体 (TCR) 治疗靶向乙型肝炎表面抗原 (HBsAg) 具有令人鼓舞的抗病毒活性和肿瘤控制能力，这提供了第一个临床概念验证，”该中心主任 Ulrike Protzer 教授说慕尼黑亥姆霍兹和慕尼黑工业大学病毒学研究所，SCG 科学创始人。 “这些早期结果支持 SCG101 的持续开发，用于治疗 HBV 相关肝细胞癌患者，我们看到了高度未满足的医疗需求。”

SCG101 的安全性与 T 细胞治疗中预期的副作用一致。没有观察到神经毒性，也没有导致治疗中断的治疗相关 AE 或 SAE（不良事件或严重不良事件）。在所有三名患者中均观察到伴有发热和腹胀的治疗相关细胞因子释放综合征 (CRS)。观察到短暂的 ALT 和 AST 增加，没有胆红素升高或临床症状，但由于靶细胞清除的 SCG101 机制而预期。

“SCG101的结果首次表明，HBsAg导向的TCR T细胞疗法可以为HBV相关的HCC患者提供抗病毒和肿瘤控制的双重益处，”北京协和医学院肝病学家、院长杜顺达博士说。试验的调查员。 “慢性 HBV 感染占全球所有肝癌患者的一半以上。针对 HBV 的 TCR 疗法的发展促使我们重新考虑将乙型肝炎作为肝癌患者诊断和治疗计划的一个因素。”

“我们很自豪能与我们的合作医院合作，提供世界上第一个针对 HBV 的 TCR T 细胞疗法的临床概念验证，我们相信这验证了我们平台的实力，并为我们探索治疗的进一步突破性发现打开了大门SCG 首席科学官 Ke Zhang 博士说。

SCG101于2022年5月获得中国国家药品监督管理局（NMPA）和新加坡卫生科学局（HSA）的临床试验批件，是国家药品监督管理局批准的首个治疗HCC的TCR-T细胞治疗产品，也是首个多-中国和新加坡在细胞治疗领域的国家临床试验批准。

关于SCG101

SCG101是一种自体 T 细胞受体 (TCR) T 细胞疗法，是一种针对乙型肝炎表面抗原 (HBsAg) 特定表位的研究性细胞疗法产品。 SCG101采用了 SCG 的专有技术，该技术允许使用具有高灵敏度和亲和力的病毒特异性 TCR 选择性地对功能失调的感染细胞和肿瘤细胞进行重定向和工程化内源性 T 细胞。 SCG101的临床前研究证明了肿瘤抑制和HBV cccDNA根除。 2022年，SCG101获得了中国国家药品监督管理局（NMPA）和新加坡卫生科学局（HSA）的临床试验批准，用于治疗HBV相关的HCC。评估 SCG101 的 1/2 期研究正在进行中。
关于肝癌

肝细胞癌（HCC）是最常见的肝癌类型。据估计，到 2020 年，全球将有超过 905,000 例新发肝癌病例和超过 830,100 例死于该疾病，使其成为全球癌症死亡的主要原因之一 [1]。慢性乙型肝炎病毒 (HBV) 感染占全球 HCC 病例的至少 50% [2]。 HCC通常被诊断为晚期，并且与预后不良有关。五年生存率不足15%。

关于 SCG 细胞疗法

SCG 是一家领先的生物技术公司，专注于开发针对感染及其相关癌症的新型免疫疗法。该公司针对最常见的致癌感染：幽门螺杆菌、人乳头瘤病毒和乙型肝炎，并开发了广泛而独特的 T 细胞疗法、抗体和治疗性疫苗来预防和治愈相关癌症。 SCG成立并总部设在新加坡，结合新加坡、中国和德国的区域优势，覆盖从创新药物研发、制造、临床开发和商业化的全价值链。 SCG 与领先的科学家和研究人员合作，带来一流和一流的医疗产品/技术，以加强医疗产品开发的创新。

有关 SCG 的更多信息，请访问我们的网站 www.scgcell.com

StephenW

SCG Cell Therapy Presents Clinical Proof-of-Concept Data at International Liver Congress (ILC) 2022 Annual Meeting

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Jun 23, 2022, 05:00 ET
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    Clinical trial interim results of SCG101 shows tumour control with lesion shrinkage observed in two out of three patients with advanced HBV-related HCC
    Results show rapid and significant serum HBsAg reduction indicates signal of antiviral activity
    Data presented support the advancement of SCG101 to Phase 1/2 of the clinical trials globally

SINGAPORE, June 23, 2022 /PRNewswire/ -- 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). The data showed significant antiviral activity and tumour control in two of three patients. This set of data was presented at the International Liver Congress (ILC) 2022 Annual Meeting in London on 23 June.

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.

"These data showed encouraging antiviral activity and tumour control by a unique T cell receptor (TCR) therapeutic targeting hepatitis B surface antigen (HBsAg) which provides the first clinical proof-of-concept," said Prof. Dr Ulrike Protzer, Director of the Institute of Virology at Helmholtz Munich and Technical University of Munich and Scientific Founder of SCG. "These early results support the continued development of SCG101 for patients with HBV-associated hepatocellular carcinoma where we see a high unmet medical need."

The safety profile of SCG101 was consistent with the side effects expected in T cell therapy. There was no neurotoxicity observed and also no treatment-related AE or SAE (Adverse Event or Serious Adverse Event) which led to treatment discontinuation. Treatment-related cytokine release syndrome (CRS) with fever and bloating were observed in all three patients. Transient ALT and AST increase, without bilirubin elevation or clinical symptoms, was observed but expected due to SCG101 mechanisms of target cells clearance.

"The results of SCG101 show for the first time that an HBsAg directed TCR T cell therapy can provide dual benefit of antiviral and tumour control to patients with HBV-related HCC," said Shunda Du, MD, hepatologist, Peking Union Medical College and principal investigator for the trial. "Chronic HBV infection accounts for more than half of all patients with liver cancer worldwide. The development of HBV-directed TCR therapeutic prompts us to reconsider hepatitis B as a factor in diagnosis and treatment planning for patients with liver cancer."

"We're proud to collaborate with our partnered hospitals to deliver the world's first clinical proof of concept for TCR T cell therapy targeting HBV, which we believe validates the strength of our platform and opens doors for us to explore further breakthrough discoveries for the treatment of other cancers and diseases with high unmet need," said Dr Ke Zhang, Chief Scientific Officer of SCG.

SCG101 was granted clinical trial approvals by China National Medical Products Administration (NMPA) and Singapore Health Science Authority (HSA) in May 2022. It is the first TCR-T cell therapy product approved by the NMPA for the treatment of HCC and the first multi-country clinical trial approval across China and Singapore in the field of cell therapy.

About SCG101

SCG101, an autologous T-cell receptor (TCR) T cell therapy, is an investigational cell therapy product that targets specific epitopes of hepatitis B surface antigen (HBsAg). SCG101 incorporates SCG's proprietary technology, which allows for redirecting and engineering endogenous T cells using virus-specific TCRs with high sensitivity and avidity selectively against dysfunctional infected and tumour cells. Preclinical studies of SCG101 demonstrated tumour inhibition and HBV cccDNA eradication. In 2022, SCG101 was granted clinical trial approvals by the China National Medical Products Administration (NMPA) and Singapore Health Science Authority (HSA) for the potential treatment of HBV-related HCC. The Phase 1/2 study evaluating SCG101 is underway.
About Liver Cancer

Hepatocellular carcinoma (HCC) is the most common type of liver cancer. It is estimated more than 905,000 new cases of liver cancer and more than 830,100 deaths from the disease globally in 2020, making it one of the leading causes of cancer deaths around the world [1]. Chronic hepatitis B virus (HBV) infection accounts for at least 50% of cases of HCC worldwide [2]. HCC is typically diagnosed at an advanced stage and is associated with a poor prognosis. The five-year survival rate of less than 15%.

About SCG Cell Therapy

SCG is a leading biotechnology company focusing on the development of novel immunotherapies for infections and their associated cancers. The company targets the most common cancer-causing infections: helicobacter pylori, human papillomavirus, and hepatitis B, and develops a broad and unique pipeline of T cell therapies, antibodies, and therapeutic vaccines against infections to prevent and cure its associated cancers. Established and headquartered in Singapore, SCG combines regional advantages in Singapore, China and Germany, covering the entire value chain from innovative drug research and discovery, manufacturing, clinical development and commercialization. SCG collaborates with leading scientists and researchers to bring first-in-class and best-in-class medical products/technologies to enhance innovation in medical product development.

For more information about SCG, please visit us at www.scgcell.com