SCG101V IND Clearance in China – SCG Cell Therapy
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SCG Cell Therapy has announced the U.S. Food and Drug Management (FDA) clearance of its Investigational New Drug (IND) application for SCG101,a novel autologous T cell receptor (TCR) T cell therapy. This clearance expands the potential application of SCG101 to include patients with HBV-related cholangiocarcinoma, along with its ongoing development for chronic Hepatitis B virus (HBV) infection and hepatocellular carcinoma (HCC). This marks a important step forward in the field of cell therapy, offering a potential new treatment avenue for challenging liver diseases and cancers.
SCG101: A First-in-Class TCR-T Cell Therapy
SCG101 is designed to selectively target a specific epitope of the hepatitis B surface antigen (HBsAg). Utilizing SCG’s proprietary GianTCR™ screening platform, the therapy identifies natural, high-affinity, high-avidity TCRs that recognize intracellular antigens presented via the major histocompatibility complex (MHC). This precise targeting aims to deliver immune-mediated clearance of both infected and malignant cells.
Preclinical and clinical studies have demonstrated SCG101’s ability to inhibit tumor growth and eradicate HBV covalently closed circular DNA (cccDNA) – a key factor in chronic HBV infection. The FDA’s IND clearance for HBV-related cholangiocarcinoma underscores the promising potential of this innovative approach.
“HBV-related cholangiocarcinoma,and chronic hepatitis B,this IND clearance further validates our development strategy-expanding from virus-induced cancers to chronic infectious diseases,” said Christy Ma,Chief Executive Officer of SCG Cell Therapy. “SCG101 is the first cell therapy product to receive regulatory approval to enter a phase 1/2 clinical trial specifically for HBV and HBV-induced cancer, and we are proud to lead the way in advancing toward a long-term functional cure. We remain on track for initiation of a pivotal study, following the recent completion of our Phase 1 study in patients with HBV-HCC. We look forward to sharing additional clinical data as we continue to push the boundaries of what’s possible in cell therapy.”
The Global Burden of Hepatitis B and the Need for Novel Therapies
Hepatitis B is a serious liver infection caused by the HBV, capable of becoming chronic and significantly increasing the risk of cirrhosis and liver cancer. Globally, nearly 300 million people are affected by chronic HBV infection. Despite the availability of vaccines and existing treatments, approximately 1.1 million people die annually from complications related to the virus.
This ample public health burden highlights the urgent need for innovative therapies that can achieve a functional cure – meaning sustained control of the virus without the need for lifelong medication. SCG101 represents a possibly transformative approach, aiming to harness the power of the immune system to eliminate the virus and prevent disease progression.
Cholangiocarcinoma, or bile duct cancer, is a especially aggressive form of cancer with limited treatment options. HBV infection is a known risk factor for developing cholangiocarcinoma, especially in regions with high HBV prevalence. The expansion of SCG101’s clinical development to include this indication addresses a critical unmet medical need for patients with this challenging cancer.
SCG Cell Therapy is a biotechnology company focused on developing novel immunotherapies targeting infectious diseases and their associated cancers. The company’s pipeline focuses on cancers caused by common infections, including Helicobacter pylori, HPV, HBV, and EBV.
Headquartered in Singapore, SCG operates across Singapore, China, and germany, integrating research, revelation, manufacturing, clinical development, and commercialization. This global footprint allows SCG to leverage regional expertise and accelerate the development of its TCR-based therapeutics.
For more facts, visit www.scgcell.com.