标题: SCG 细胞疗法宣布美国 FDA 批准 SCG101 的研究性新药申请，SCG [打印本页] 作者: StephenW 时间: 2022-7-12 22:47 标题: SCG 细胞疗法宣布美国 FDA 批准 SCG101 的研究性新药申请，SCG
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。
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。作者: StephenW 时间: 2022-7-12 22:47
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.作者: 未来可期1 时间: 2022-7-12 22:55