SCG 细胞疗法宣布美国 FDA 批准 SCG101 的研究性新药申请，SCG

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SCG 细胞疗法宣布美国 FDA 批准 SCG101 的研究性新药申请，SCG 的新型 TCR-T 细胞疗法用于治疗乙型肝炎相关肝癌

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美国东部时间 2022 年 7 月 11 日 01:29
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新加坡，2022 年 7 月 11 日 /美通社/ -- 总部位于新加坡的 SCG 细胞疗法私人有限公司（“SCG”）宣布，美国食品药品监督管理局（Food and Drug Administration）（ FDA ）已批准 SCG101的研究性新药（ IND ）申请，这是一种研究性 T - 细胞受体 (TCR) T 细胞治疗乙型肝炎病毒 (HBV) 相关肝癌患者。这一批准启动了全球 SCG101 1/2 期临床试验的推进。

此次公告是继 SCG 此前于 2022 年 3 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) 于 2022 年 5 月获得 IND 批准之后。这进一步确立了 SCG101作为首个获批进入临床试验的 TCR-T 细胞治疗产品美国、中国和新加坡。

“SCG 领先的细胞治疗产品 SCG101 在美国和亚洲获得 IND 的批准对公司来说是一个重要的里程碑，”SCG 细胞治疗首席执行官 Frank Wang 说。 “我们渴望启动国际多中心临床试验，利用我们的 TCR-T 技术为患者提供创新的治疗选择。”

SCG101是一种自体TCR T细胞疗法，可以识别由特异性主要组织相容性复合物（MHC）I类分子呈现在细胞表面的HBV衍生T细胞表位。通过特定的 HLA 分型，SCG101 可以使 T 细胞特异性地针对 HBV 抗原，不仅可以靶向和消除 HBsAg 阳性 HCC 细胞，还可以根除 HBV cccDNA（共价闭合环状 DNA）。

“我们之前的临床前和临床研究表明，SCG101具有双重抗病毒和抗肿瘤活性，这是SCG在癌症药物开发中非常重要和令人兴奋的临床概念验证，”SCG Cell 首席科学官 Ke Zhang 博士说治疗。 “我们认为，肿瘤微环境是实体瘤细胞治疗成功的主要障碍。将 T 细胞特异性重定向到 HBsAg 阳性 HCC 细胞以及 HBV 感染的细胞可能会诱导免疫级联反应改变肿瘤微环境，并提供一条更好的道路。患者的结果。”

2022 年 6 月，SCG 细胞疗法在第 57 届 EASL 年会 2022 年国际肝病大会（ILC）上公布了一项由研究者发起的 SCG101临床试验的中期数据。该试验评估了单剂量 SCG101 对至少接受过两种癌症治疗的晚期 HBV 相关肝细胞癌 (HCC) 患者的疗效。数据显示出显着的抗病毒活性和肿瘤控制。三分之二的患者在 SCG101 治疗后的短短 28 天内观察到病灶缩小以及血清 HBsAg 从基线 1,004.3 IU/mL 和 521.6 IU/mL 快速显着降低至 23.8 IU/mL 和 9.1 IU/mL，并进一步降低治疗后 60 天内降至 14.0 IU/m 和 0.3 IU/mL。

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获得了美国食品药品监督管理局（FDA）、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 期临床试验正在进行中。

StephenW

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

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Jul 11, 2022, 01:29 ET
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SINGAPORE, July 11, 2022 /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. This further establishes SCG101 as the first TCR-T cell therapy product approved for clinical trial across the U.S, China and Singapore.

"Clearance of the IND for SCG's leading cell therapy product SCG101 across the United States and Asia is an important milestone for the company," said Frank Wang, Chief Executive Officer of SCG Cell Therapy. "We are eager to start international multicenter clinical trial that utilizes our TCR-T technologies to offer innovative treatment option for patients."

SCG101 is an autologous TCR T cell therapy that can recognize HBV-derived T cell epitope presented on the cell surface by specific major histocompatibility complex (MHC) class I molecules. With the specific HLA typing, SCG101 can redirect T cells specifically against the HBV antigen not only to target and eliminate HBsAg-positive HCC cells but also to eradicate HBV cccDNA (covalently closed circular DNA).

"Our previous preclinical and clinical studies demonstrated that SCG101 has dual antiviral and antitumor activities, which is a profoundly important and exciting clinical proof-of-concept for SCG in cancer drug development," stated Ke Zhang, PhD, Chief Scientific Officer of SCG Cell Therapy. "We believe tumour microenvironment is a major barrier to successful cell therapy in solid tumours. Redirecting T cells specifically against HBsAg-positive HCC cells as well as HBV-infected cells could potentially induce immunological cascades altering the tumour microenvironment and offer a path forward to better outcomes for patients."

In June 2022, SCG Cell Therapy presented interim data from an investigator-initiated clinical trial of SCG101 at the International Liver Congress (ILC) 2022, the 57th EASL Annual Meeting. The trial evaluated single-dose SCG101 in patients with advanced HBV-related hepatocellular carcinoma (HCC) who had received at least two prior cancer therapies. The data showed significant antiviral activity and tumour control. Two out of three patients observed lesion shrinkage as well as rapid and significant serum HBsAg reduction from a baseline of 1,004.3 IU/mL and 521.6 IU/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.

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 U.S Food and Drug Administration (FDA), China National Medical Products Administration (NMPA) and Singapore Health Science Authority (HSA) for the potential treatment of HBV-related HCC. The Phase 1/2 clinical trial evaluating SCG101 is underway.

未来可期1

可以根除CCC DNA，很厉害呀