Hepatitis B Virus-Related Hepatocellular Carcinoma

SINGAPORE I February 11, 2025 I On 12 Feb 2025 (Singapore Time), Lion TCR announced that its mRNA-encoded T-cell receptor (TCR)-T cell therapy product Liocyx-M004 has received clearance from the U.S. Food and Drug Administration (FDA) to initiate an international multicenter Phase 2 clinical trial. This significant progress further solidifies Lion TCR’s leading position in the mRNA-based TCR-T field and brings new hope to patients with hepatocellular carcinoma (HCC). Hepatitis B and liver cancer are significant global public health challenges. Hepatitis B virus (HBV) infection is a leading risk factor for liver cancer, particularly HCC. Globally, an estimated 296 million people live with chronic HBV infection. Liver cancer is the sixth most common cancer worldwide. In 2020 alone, there were approximately 905,000 new cases and 830,000 deaths from liver cancer globally. Liocyx-M004 is the world’s first mRNA-encoded TCR-T cell therapy targeting HBV-related hepatocellular carcinoma. The FDA-approved international multicenter Phase 2 clinical trial will evaluate the efficacy of Liocyx-M004 as a monotherapy and in combination with lenvatinib. Lenvatinib, a well-established first-line treatment for advanced hepatocellular carcinoma, demonstrates the ability to reprogram the immunosuppressive tumour microenvironment into an immune-supportive state, thereby enhancing tumour-killing efficacy. When combined with Liocyx-M004, this therapy is anticipated to create synergistic effects, further amplifying its anti-tumour potential and improving patient outcomes. Dr. Tina Wang, Chief Medical Officer and Chief Operating Officer of Lion TCR, explained: “In patients with HBV-related hepatocellular carcinoma, HBV-specific T cells are often functionally exhausted, leading to a significant impairment in their ability to eliminate liver cancer cells and HBV-infected liver cells with HBV-DNA integration. Our research has shown that HBV-specific TCR-T cells can effectively target and destroy these cancerous cells. This makes the adoptive transfer and supplementation of autologous HBV-specific TCR-T cells a promising therapeutic strategy, with the potential to restore the HBV-specific T cell pool in patients. This approach enables targeted killing of liver cancer cells and infected liver cells expressing HBV antigens, providing a novel treatment option for HBV-related hepatocellular carcinoma. While systemic therapies for advanced hepatocellular carcinoma have made significant strides in recent years, including the development of targeted combination immunotherapies, precision treatments for HBV-related hepatocellular carcinoma remain limited. By investigating the combination of Liocyx-M004 with lenvatinib, we aim to further improve response rates and survival outcomes for these patients. The FDA’s approval of this international multicenter Phase 2 clinical trial is a major milestone that strengthens our confidence and commitment to advancing mRNA-encoded TCR-T therapies for hepatocellular carcinoma. Moving forward, we will accelerate the trial’s progress and gather clinical data to bring this innovative treatment to patients as soon as possible.” Dr. Xiaoming Peng, CEO of Lion TCR, remarked: “Liocyx-M004 is the first TCR-T therapy targeting HBV viral antigens to receive IND approval from the U.S. FDA and the first of its kind to be granted Fast Track designation. This approval for Liocyx-M004 to proceed with international multicenter Phase 2 clinical trials underscores its significance as an innovative therapy for liver cancer and represents a major milestone for Lion TCR. It also signifies a critical step in Lion TCR’s transition from the clinical stage to commercialization. While advancing our lead product through these critical trials, we are simultaneously accelerating the development of an ‘off-the-shelf’ (or ‘universal’) in vivo TCR-T product platform, leveraging mRNA-LNP delivery technology to significantly reduce production costs. In parallel, we are enhancing our AI-powered TCR discovery platform to expand our pipeline into treatments for various solid tumors with high unmet needs, including lung cancer, breast cancer, and gastrointestinal cancers.” Liocyx-M004 has already demonstrated promising outcomes in earlier clinical trials, achieving a median overall survival of 33.1 months in patients with HBV-related hepatocellular carcinoma. About Lion TCR Lion TCR is a clinical-stage biotechnology company, originally spun off from Singapore’s Agency for Science, Technology and Research (A*STAR), and a pioneer in mRNA-encoded TCR-T cell therapies for the treatment of solid tumors and infectious diseases. Its flagship product, Liocyx-M004, is the world’s first FDA-approved TCR-T cell therapy targeting HBV-related hepatocellular carcinoma (HCC) to enter international multicenter Phase 2 clinical trials. The therapy has also been granted FDA Fast Track and Orphan Drug designations. In November 2024, Lion TCR achieved another milestone with IND approval from China’s National Medical Products Administration (NMPA), marking significant progress in advancing TCR-T cell therapy. By leveraging cutting-edge mRNA technology and an AI-driven TCR discovery platform, Lion TCR is expanding its pipeline to target various solid tumors and infectious diseases, including lung cancer, breast cancer, and gastrointestinal cancer. The company is also developing both autologous cell therapies and ‘off-the-shelf’ therapies using mRNA-LNP delivery technology to significantly reduce production costs while ensuring scalability in manufacturing. Lion TCR has successfully raised over 300 million yuan in funding, led by Guangzhou Industrial Investment Fund, alongside Guangzhou Guoju Investment Fund (a private equity subsidiary of Guangzhou Hi-Tech Investment Group Co., Ltd.) and CSPC NARD Capital Fund. The company has established its China headquarters in Guangzhou Sino-Singapore Knowledge City and is constructing a GMP-compliant innovative drug facility. This facility complements its GMP base in Singapore, creating a comprehensive global platform that integrates research, clinical operations, and production. Through its China-Singapore collaboration, Lion TCR aims to establish itself as a global leader in mRNA-encoded TCR-T cell therapies. SOURCE: Lion TCR

SINGAPORE, Feb. 11, 2025 /PRNewswire/ -- On 12 Feb 2025 (Singapore Time), Lion TCR announced that its mRNA-encoded T-cell receptor (TCR)-T cell therapy product Liocyx-M004 has received clearance from the U.S. Food and Drug Administration (FDA) to initiate an international multicenter Phase 2 clinical trial. This significant progress further solidifies Lion TCR's leading position in the mRNA-based TCR-T field and brings new hope to patients with hepatocellular carcinoma (HCC). Continue Reading U.S. Food and Drug Administration Hepatitis B and liver cancer are significant global public health challenges. Hepatitis B virus (HBV) infection is a leading risk factor for liver cancer, particularly HCC. Globally, an estimated 296 million people live with chronic HBV infection. Liver cancer is the sixth most common cancer worldwide. In 2020 alone, there were approximately 905,000 new cases and 830,000 deaths from liver cancer globally. Liocyx-M004 is the world's first mRNA-encoded TCR-T cell therapy targeting HBV-related hepatocellular carcinoma. The FDA-approved international multicenter Phase 2 clinical trial will evaluate the efficacy of Liocyx-M004 as a monotherapy and in combination with lenvatinib. Lenvatinib, a well-established first-line treatment for advanced hepatocellular carcinoma, demonstrates the ability to reprogram the immunosuppressive tumour microenvironment into an immune-supportive state, thereby enhancing tumour-killing efficacy. When combined with Liocyx-M004, this therapy is anticipated to create synergistic effects, further amplifying its anti-tumour potential and improving patient outcomes. Dr. Tina Wang, Chief Medical Officer and Chief Operating Officer of Lion TCR, explained: "In patients with HBV-related hepatocellular carcinoma, HBV-specific T cells are often functionally exhausted, leading to a significant impairment in their ability to eliminate liver cancer cells and HBV-infected liver cells with HBV-DNA integration. Our research has shown that HBV-specific TCR-T cells can effectively target and destroy these cancerous cells. This makes the adoptive transfer and supplementation of autologous HBV-specific TCR-T cells a promising therapeutic strategy, with the potential to restore the HBV-specific T cell pool in patients. This approach enables targeted killing of liver cancer cells and infected liver cells expressing HBV antigens, providing a novel treatment option for HBV-related hepatocellular carcinoma. While systemic therapies for advanced hepatocellular carcinoma have made significant strides in recent years, including the development of targeted combination immunotherapies, precision treatments for HBV-related hepatocellular carcinoma remain limited. By investigating the combination of Liocyx-M004 with lenvatinib, we aim to further improve response rates and survival outcomes for these patients. The FDA's approval of this international multicenter Phase 2 clinical trial is a major milestone that strengthens our confidence and commitment to advancing mRNA-encoded TCR-T therapies for hepatocellular carcinoma. Moving forward, we will accelerate the trial's progress and gather clinical data to bring this innovative treatment to patients as soon as possible." Dr. Xiaoming Peng, CEO of Lion TCR, remarked: "Liocyx-M004 is the first TCR-T therapy targeting HBV viral antigens to receive IND approval from the U.S. FDA and the first of its kind to be granted Fast Track designation. This approval for Liocyx-M004 to proceed with international multicenter Phase 2 clinical trials underscores its significance as an innovative therapy for liver cancer and represents a major milestone for Lion TCR. It also signifies a critical step in Lion TCR's transition from the clinical stage to commercialization. While advancing our lead product through these critical trials, we are simultaneously accelerating the development of an 'off-the-shelf' (or 'universal') in vivo TCR-T product platform, leveraging mRNA-LNP delivery technology to significantly reduce production costs. In parallel, we are enhancing our AI-powered TCR discovery platform to expand our pipeline into treatments for various solid tumors with high unmet needs, including lung cancer, breast cancer, and gastrointestinal cancers." Liocyx-M004 has already demonstrated promising outcomes in earlier clinical trials, achieving a median overall survival of 33.1 months in patients with HBV-related hepatocellular carcinoma. About Lion TCR Lion TCR is a clinical-stage biotechnology company, originally spun off from Singapore's Agency for Science, Technology and Research (A*STAR), and a pioneer in mRNA-encoded TCR-T cell therapies for the treatment of solid tumors and infectious diseases. Its flagship product, Liocyx-M004, is the world's first FDA-approved TCR-T cell therapy targeting HBV-related hepatocellular carcinoma (HCC) to enter international multicenter Phase 2 clinical trials. The therapy has also been granted FDA Fast Track and Orphan Drug designations. In November 2024, Lion TCR achieved another milestone with IND approval from China's National Medical Products Administration (NMPA), marking significant progress in advancing TCR-T cell therapy. By leveraging cutting-edge mRNA technology and an AI-driven TCR discovery platform, Lion TCR is expanding its pipeline to target various solid tumors and infectious diseases, including lung cancer, breast cancer, and gastrointestinal cancer. The company is also developing both autologous cell therapies and 'off-the-shelf' therapies using mRNA-LNP delivery technology to significantly reduce production costs while ensuring scalability in manufacturing. Lion TCR has successfully raised over 300 million yuan in funding, led by Guangzhou Industrial Investment Fund, alongside Guangzhou Guoju Investment Fund (a private equity subsidiary of Guangzhou Hi-Tech Investment Group Co., Ltd.) and CSPC NARD Capital Fund. The company has established its China headquarters in Guangzhou Sino-Singapore Knowledge City and is constructing a GMP-compliant innovative drug facility. This facility complements its GMP base in Singapore, creating a comprehensive global platform that integrates research, clinical operations, and production. Through its China-Singapore collaboration, Lion TCR aims to establish itself as a global leader in mRNA-encoded TCR-T cell therapies. SOURCE Lion TCR WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SINGAPORE I November 25, 2024 I SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company focused on developing innovative immunotherapies for infectious diseases and associated cancers, announced late-breaking data from its Phase 1 trial of SCG101, a first-in-class autologous hepatitis B virus (HBV)-specific T-cell receptor-engineered T Cell (TCR-T) therapy targeting hepatitis B surface antigen (HBsAg). The data was presented at the 2024 AASLD Liver Meeting in San Diego, United States. In the Phase 1 clinical trial, SCG101 exhibited promising antiviral activity in patients with advanced HBV-related hepatocellular carcinoma (HBV-HCC). Among the 12 patients treated with a single intravenous dose of SCG101 at 5.0×10 7 ~ 1.0×10 8 TCR + T cells/kg, all patients demonstrated a significant reduction in serum HBsAg levels, with 11 out of 12 (92%) patients achieving a reduction of 1.0 to 4.6 log 10 , and the levels remaining below 100 IU/mL throughout the follow-up period of up to one year. Notably, four patients (33%) experienced HBsAg loss within 21 days following a single infusion of SCG101 and which persisted throughout the follow-up. The safety profile of SCG101 was generally favourable, with the therapy being well tolerated. The most commonly reported treatment-related adverse events included transient elevations in liver enzymes, pyrexia, cytopenia, cytokine release syndrome (CRS), hypoalbuminemia, and hyponatremia—consistent with SCG101’s mechanism of action, which involves the HBsAg-targeted immune activation and its mediated clearance of diseased hepatocytes and HCC cells. HBV remains a major global health burden, affecting over 250 million people worldwide. It is a leading cause of liver cancer, responsible for 50%–80% of hepatocellular carcinoma cases globally. 1 Chronic HBV infection leads to the integration of HBV DNA into the host genome, resulting in persistent HBsAg expression, chromosomal instability, and activation of oncogenes, thereby contributing to the development of hepatocellular carcinoma. 2 SCG101 is designed to target a specific HBV peptide presented on infected cells, as well as hepatocytes with HBV DNA integration. By triggering both cytolytic and non-cytolytic mechanisms, SCG101 effectively eliminates HBV-infected hepatocytes as well as premalignant and HBV-HCC cells with HBV-DNA integration. “The positive data from our Phase 1 trial marks a significant milestone in the development of SCG101, our first-in-class HBV-specific TCR-T therapy. These results not only demonstrate the potential of SCG101 to achieve meaningful and durable antiviral responses in patients, but also underscore the unique approach we are taking in HBV-specific TCR T cell therapy. We are encouraged by these early findings and are committed to advancing SCG101 through clinical development as we work towards providing a new therapeutic option for patients suffering from this challenging disease”, said Christy Ma, Chief Executive Officer of SCG Cell Therapy. “We believe our GianT TM TCR discovery platform has the potential to address a broad spectrum of infection-associated cancers, such as human papillomavirus (HPV) associated cervical cancer and head and neck cancer, and Epstein-Barr virus (EBV) associated nasopharyngeal carcinoma and gastric cancer, paving the way for a new paradigm in immune-based cancer treatment”. About SCG101 SCG101 is an investigational autologous T-cell receptor (TCR) T cell therapy that targets a specific epitope of the hepatitis B surface antigen (HBsAg). Leveraging SCG’s proprietary GianT TM technology, our TCR screening platform identifies high-affinity and high-avidity natural TCRs against intracellular antigens presented via the major histocompatibility complex (MHC) in solid tumors. Both preclinical and clinical studies of SCG101 have demonstrated significant tumor inhibition and the eradication of HBV covalently closed circular DNA (cccDNA). SCG101 has received clinical trial approvals from the U.S. Food and Drug Administration (FDA), the China National Medical Products Administration (NMPA), the Singapore Health Sciences Authority (HSA), and the Hong Kong Department of Health (DOH) for the treatment of patients with HBV-related hepatocellular carcinoma (HCC). A Phase 1/2 clinical trial evaluating SCG101 is currently underway (NCT05417932). About Hepatocellular carcinoma Hepatocellular carcinoma (HCC) is the most common type of liver cancer. In 2020, it was estimated that over 905,000 new cases of liver cancer were diagnosed, and more than 830,100 deaths occurred globally, making it one of the leading causes of cancer-related mortality. 3 Chronic hepatitis B virus (HBV) infection is responsible for at least 50% of HCC cases worldwide. 1 HCC is typically diagnosed at an advanced stage, contributing to a poor prognosis with a five-year survival rate of less than 15%. 4 About SCG Cell Therapy SCG Cell Therapy is a leading biotechnology company dedicated to developing novel immunotherapies for infectious diseases and associated cancers. The company focuses on targeting some of the most common cancer-causing infections, including Helicobacter pylori, HPV, HBV, and EBV. SCG is advancing a broad pipeline of TCR-based therapeutics aimed at preventing and curing infection-related cancers. Headquartered in Singapore, SCG operates across Singapore, China, and Germany, leveraging regional strengths to cover the entire value chain, from innovative drug research and discovery to manufacturing, clinical development, and commercialization. For more information, please visit www.scgcell.com . [1] Y, Xie. (2017). Hepatitis B virus-associated hepatocellular carcinoma. Advances in experimental medicine and biology. [2] Jiang, Y., Han, Q., Zhao, H., Zhang, J. (2021, May 20). The mechanisms of HBV-induced hepatocellular carcinoma. Journal of hepatocellular carcinoma. [3] Liver cancer statistics: World cancer research fund international. WCRF International. (2022, April 14). [4] Golabi P, Fazel S, Otgonsuren M, Sayiner M, Locklear CT, Younossi ZM. (2017). Mortality assessment of patients with hepatocellular carcinoma according to underlying disease and treatment modalities. SOURCE: SCG Cell Therapy