SCG Biopharma's TCR-T Therapy SCG101 Receives FDA IND Approval, Becoming First Globally to Secure Clinical Clearance from U.S., China, and Singapore

ShanghaiJuly 5, 2022PR Newswire -- July 5, 2022, Singapore-based innovative biopharmaceutical company -- SCG Cell Therapy Pte. Ltd. (SCG) announced that its investigational novel TCR-T cell injection -- SCG101 received clinical trial approval from the U.S. Food and Drug Administration (FDA) at the end of June. SCG will fully initiate a Phase 1/2 clinical trial of SCG101 in the United States to systematically explore the safety and efficacy of treating hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC).

SCG101 Receives FDA Approval for Clinical Trials in the U.S. Following IND Approvals from China’s NMPA in March and Singapore’s HSA in May

Today, despite the widespread vaccination against hepatitis B, the hepatitis B virus remains one of the major global health threats and is listed by the World Health Organization as a "Class I carcinogen" with high infectivity. According to WHO data, approximately 257 million people worldwide are chronically infected with hepatitis B. China, being a country with a high prevalence of hepatitis B, has nearly 90 million hepatitis B carriers, with about 400,000 new cases of liver cancer caused by the hepatitis B virus each year, accounting for half of the world's total. The number of deaths ranks second only to lung cancer. Although comprehensive hepatitis B vaccination has significantly suppressed transmission, it cannot completely prevent hepatitis B infection. Statistics show that the number of newly infected individuals in China remains high, with over one million new infections annually. Hepatitis B carriers can gradually develop chronic hepatitis B due to continuous viral replication and activity, which is highly contagious. About 20% of chronic hepatitis B patients will progress to liver cancer within 10-20 years. Liver cancer patients often do not exhibit obvious symptoms, and when diagnosed, the disease is usually already at an advanced stage. The burden of chronic hepatitis B in China remains quite severe, making the prevention and treatment of hepatitis B an urgent task. To achieve the goal of "Eliminating Hepatitis B and Preventing Liver Cancer," SCG Cell Therapy Pte. Ltd. is actively developing innovative products targeting various stages of hepatitis and liver cancer. SCG101, the company’s first innovative TCR-T cell therapy for hepatitis B-related liver cancer, has received approval in the U.S., China, and Singapore. It works by introducing virus-specific TCR gene sequences to redirect T cells to express specific T-cell receptors targeting the hepatitis B surface antigen (HBsAg), selectively eliminating HBV-infected liver cells and liver cancer cells. Dr. Zhang Ke, Chief Scientific Officer of SCG Cell Therapy Pte. Ltd., stated: "HBV not only causes chronic hepatitis but also integrates its genome into the host liver cell genome, disrupting genomic stability and further inducing liver cancer. Therefore, T-cell therapies targeting HBsAg have become a novel therapeutic strategy for HBV-related liver cancer."

The cell therapy presented exciting research data at the 57th Annual Meeting of the European Association for the Study of the Liver (EASL) held in London on June 23. In a clinical trial for the treatment of advanced hepatitis B virus-related liver cancer, SCG101 demonstrated significant antiviral and antitumor dual activity, with rapid and sustained reduction in serum HBsAg, significant shrinkage of tumor lesions, and a disease control rate of 66%. This marks a major milestone for TCR-T cell therapy in the field of virus-associated solid tumors and represents the world’s first targeted HBsAg cell therapy to achieve clinical proof-of-concept, showing great potential to become a first-in-class product in this field.

Professor Du Shunda from the Hepatobiliary Surgery Department of Peking Union Medical College Hospital stated in an interview with *International Liver Disease* that SCG101 has demonstrated good safety and efficacy in HBV-related liver cancer patients who have previously undergone second-line or higher systemic treatments. Based on current results, the anti-tumor activity of SCG101 will become a focal point for further development and holds significant potential in the field of liver cancer treatment, representing a promising new breakthrough in the future.

SCG101, developed by SCG Cell Therapy Pte. Ltd., focuses on immunotherapy for major chronic diseases caused by infections and related cancers, including hepatitis B virus infection and liver cancer, Helicobacter pylori infection and stomach cancer, HPV infection and cervical cancer. SCG101 is one of the core products of SCG Cell Therapy Pte. Ltd. and is currently undergoing clinical trials in China and Singapore. It is expected that SCG Cell Therapy Pte. Ltd. will provide more effective innovative treatment options for patients with infections and cancer.