Hepatitis B Virus-Related Hepatocellular Carcinoma

SINGAPORE, June 7, 2024 /PRNewswire/ -- SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company developing novel immunotherapies for infectious diseases and their associated cancers, announced that clinical data from its first-in-class autologous hepatitis B virus (HBV)-specific T-cell receptor-engineered T Cell (TCR T) therapy – SCG101 – was featured in a late-breaking session during the European Association for the Study of the Liver (EASL) Congress 2024 in Milan, Italy. The presentation was selected for inclusion in the Best of EASL Congress Wrap-Up summary, distilling the best, the most memorable highlights, the future trends and the most noteworthy contributions to the program at EASL. Results from the first-in-human clinical trial showed that SCG101 exhibited promising antiviral and antitumor dual activities in patients with advanced HBV-related hepatocellular carcinoma (HCC). In six patients with advanced HBV-HCC who received SCG101 at 5.0×107 ~ 1.0×108 TCR+ T cells/kg, the objective response rate (ORR) is 33%. All patients who achieved partial responses (PR) maintained remission for over 6 months, and one had complete remission of the target lesion and remained progression-free for 27 months. The tumor responses were highly correlated with the antiviral activities of SCG101. As of the data cutoff, 4 out of 6 patients (67%) achieved serum HBsAg reduction of 1~4 log10 after single SCG101 infusion. The HBsAg level maintained ≤15 IU/mL throughout the follow up period for up to 27 months. Tumor reduction was observed in all patients with serum HBsAg reduction ≥1 log10, and the median progression free survival (PFS) and overall survival (OS) were prolonged (mPFS: 5.9 vs 0.7 months, mOS:19.0 vs 6.3 months) in patients with HBsAg reduction ≥1 log than in those without. The safety analysis revealed that SCG101 was generally well tolerated with no cases of serious adverse events (SAE) or immune effector cell-associated neurotoxicity syndrome (ICANS). The most common SCG101-related adverse events were transient liver enzymes evaluation, cytokine release syndrome (CRS) and fever, which were expected due to SCG101's mechanism of clearance of HBsAg-expressing cells. HBV infection is a leading cause of liver cancer and accounts for 50%-80% of HCC cases worldwide.[1] HBV DNA integrates into the host genome and leads to genetic instability of the host cell and epigenetic remodelling of host DNA, resulting in abnormal expression of oncogenes and HBV antigens.[2] SCG101 can specifically target an HBV peptide presented on HBV-HCC tumor cells, HBV-DNA integrated premalignant hepatocytes, and HBV-infected cells, triggering cytolytic and non-cytolytic mechanisms to eliminate tumor cells and HBV-infected cells. "We are excited that our late-breaking data was featured at the EASL Wrap-up session, presenting compelling dual antiviral and antitumor profile of SCG101 with sustained HBsAg reduction and prolonged progression-free survival and overall survival in patients with HBV-HCC," said Christy Ma, Chief Executive Officer of SCG Cell Therapy. "These data highlight the strength of our GianTCRTM platform to generate promising TCR-based therapeutic candidates across a broad range of therapeutic areas and, in particular, for the treatment of infectious diseases and its associated cancer. We look forward to further investigating SCG101 as well as other TCR candidates, bringing positive impact to patients with unmet needs." About SCG101 SCG101, an autologous T-cell receptor (TCR) T cell therapy, is an investigational cell therapy product targeting a specific epitope of hepatitis B surface antigen (HBsAg). Utilizing SCG's proprietary GianTTM technology, high affinity and high avidity natural TCRs can be identified against intracellular antigens presented through major histocompatibility complex (MHC) in solid tumours. Preclinical and clinical studies of SCG101 demonstrated tumour inhibition and HBV cccDNA eradication. 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) and Hong Kong Department of Health (DOH) for patients with HBV-related HCC. A Phase 1/2 clinical trial evaluating SCG101 is ongoing (NCT05417932). About Hepatocellular carcinoma Hepatocellular carcinoma (HCC) is the most common type of liver cancer. It is estimated that more than 905,000 new cases of liver cancer and more than 830,100 deaths from the disease globally in 2020, making it one of the leading causes of cancer deaths around the world.[3] Chronic HBV infection accounts for at least 50% of cases of HCC worldwide.[1] HCC is typically diagnosed at an advanced stage and is associated with a poor prognosis. The five-year survival rate of less than 15%.[4] About SCG Cell Therapy SCG is a leading biotechnology company focusing on the development of novel immunotherapies in infections and its associated cancers. The company targets the most common cancer-causing infections: helicobacter pylori, HPV, HBV and EBV, and develops a broad and unique pipeline of TCR-based cellular immunotherapy products against infection- associated cancers. With the proprietary GianTCRTM TCR screening platform, in-house viral vector production and AutoCellTM, a fully closed and automatic cell therapy manufacturing system, the company covers the entire value chain of cell therapy development from new target research and discovery, manufacturing, and clinical development. For more information about SCG, please visit us at . SOURCE SCG Cell Therapy Pte Ltd

CHENGDU, China, Jan. 24, 2024 /PRNewswire/ -- Kicking off the New Year with remarkable achievements, Chengdu-based WestGene made a significant impact at the 3rd mRNA-Based Therapeutics Summit in Berlin, Germany. Renowned for her pivotal role in mRNA research, Dr. Xiangrong Song, co-founder and CEO of WestGene, presented the latest advances in the company's oncology sector, with a special focus on mRNA-based cancer vaccines. Continue Reading WestGene The Summit, held January 23-25, is a key event in the field of mRNA drug development, attracting over 200 specialists from various parts of the world. This year's discussions highlighted the versatility of mRNA technology in addressing novel diseases and emphasized the importance of global collaboration in drug development and access. Insights from influential bodies such as WHO, CEPI, and EMA, as well as industry giants such as Pfizer, Sanofi, Moderna, Merck, BioNTech and CureVac, focused on the application of AI and ML in mRNA research, overcoming regulatory complexities, and advances in therapeutic development and manufacturing. In her keynote, Dr. Song discussed updates and interim data on mRNA-based cancer vaccines targeting EBV-associated cancers and HBV positive liver cancer. She discussed WestGene's breakthroughs in the treatment of specific cancers such as nasopharyngeal carcinoma, NKT lymphoma, HBV-related hepatocellular carcinoma and colorectal cancer, highlighting the safety and efficacy established by the IIT clinical trial data. This speech underscored the transformative impact of WestGene's mRNA therapy in the field of oncology. The EBV-associated cancer vaccine, a prominent project in WestGene's portfolio of over 20 mRNA initiatives, has overcome significant hurdles such as tumor vaccine efficacy and immunogenicity. Its rapid production and cost-effectiveness, coupled with its high efficacy and low toxicity, significantly improve patient accessibility, and provide a more viable treatment option for a broader patient base. This innovation was especially recognized at the 2022 National Disruptive Technology Innovation Competition, where WestGene triumphed as the only winner in the mRNA category among 2,800 entries, cementing its status as a pioneer in the biotech industry in China. Founded by two visionary scientists, Dr. Wei Yuquan and Dr. Xiangrong Song, WestGene Biotech is dedicated to pioneering the field of mRNA therapeutics. Focusing on the development of avant-garde mRNA therapeutics, the company aims to consolidate its position in the global biopharmaceutical market, backed by its robust technological infrastructure and exclusive intellectual property rights. 2023 marked a year of monumental progress for WestGene, with the acquisition of a U.S. patent for its innovative LNP delivery technology and government approval for a key project in AI-driven mRNA drug design for cancer vaccine development and protein replacement. This project, along with its extensive pipeline, positions WestGene at the forefront of biopharmaceutical innovation and research. Photo -

Lion TCR to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to develop and scale TCR-T cell therapies for solid tumors and viral-related diseases.ROCKVILLE, Md. and SINGAPORE, Jan. 03, 2024 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics and innovative bioprocessing applications, and Lion TCR, an Asia-based, clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-T cell therapies for solid tumors and life-threatening viral infections today announced the signing of a strategic platform license (SPL). This partnership will enhance MaxCyte's presence in Asia, with anticipated expansion into the US and European markets. Under the terms of the agreement, Lion TCR obtains worldwide non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive annual license fees and program-related revenue. “We are thrilled to partner with Lion TCR to support the development of their TCR-T cell therapies for hepatocellular carcinoma and life-threatening viral infections,” said Maher Masoud, President and CEO of MaxCyte. “Through this important partnership, we will be able to help provide the opportunity for patients in Asia (and ultimately patients worldwide) to benefit from these innovative mRNA-based TCR-T cell treatments and continue supporting the development of new therapies for patients with solid tumors.” Lion’s proprietary TCR-T cell therapy platform is supported by robust research, in collaboration with renowned laboratories, in the areas of autologous T cells and ’off-the-shelf’ technologies. The company’s TCR-T cell therapy harnesses the patient’s own immune system to fight against viral infections and cancers. The company is conducting ongoing clinical trials against hepatocellular carcinoma to evaluate the safety and efficacy of its TCR-T cells. Lion has engineered Hepatitis B virus (HBV)-specific T cells to recognize HBV-expressing tumor cells and achieve targeted killing, which is key as HBV is a major cause of hepatocellular carcinoma. “At Lion TCR, we aspire to be the world’s leader in the field of mRNA-based TCR-T therapeutics through the technological advancement and development of adoptive T cell therapy products for cancers and cancer-causing infectious diseases,” said CEO, Xiaoming Peng PhD, MBA. “We are honored to have MaxCyte as a partner and leverage their large-scale flow electroporation technology to support our development of novel therapeutics to benefit patients suffering from these devastating diseases.” MaxCyte’s ExPERT™ instrument portfolio is the next generation of leading, clinically-validated electroporation technology for complex and scalable cell engineering. By delivering high transfection efficiency, seamless scalability and enhanced functionality, the ExPERT™ platform delivers the high-end performance essential to enabling the next wave of biological and cellular therapeutics. Lion TCR is MaxCyte’s 24th strategic partnership overall, each of which generates pre-commercial milestone revenue and the vast majority of which include sales-based payments. About MaxCyte At MaxCyte, we pursue cell engineering excellence to maximize the potential of cells to improve patients’ lives. We have spent more than 20 years honing our expertise by building best-in-class platforms, perfecting the art of the transfection workflow, and venturing beyond today’s processes to innovate tomorrow’s solutions. Our ExPERT™ platform, which is based on our Flow Electroporation® technology, has been designed to support the rapidly expanding cell therapy market and can be utilized across the continuum of the high-growth cell therapy sector, from discovery and development through commercialization of next-generation, cell-based medicines. The ExPERT family of products includes: four instruments, the ATx™, STx™, GTx™ and VLx ™; a portfolio of proprietary related processing assemblies or disposables; and software protocols, all supported by a robust worldwide intellectual property portfolio. By providing our partners with the right technology, as well as scientific, technical and regulatory support, we aim to guide them on their journey to transform human health. Learn more at maxcyte.com and follow us on Twitter and LinkedIn. About Lion TCR Pte LtdLion TCR, a clinical stage biotech spun off from Singapore’s A*STAR, specializes in engineered T Cell Receptor (TCR) T cell therapies for infectious diseases and associated cancers, particularly HBV-related hepatocellular carcinoma (HCC). Lion TCR have secured FDA IND approval for a Phase 1b/2 trial — the world’s first FDA-approved international multi-center trial for its HBV TCR-T therapy (LioCyx-M004) against HCC. Additionally, LioCyx-M004 has received dual Fast Track and Orphan Drug Designations from the FDA. Lion TCR's groundbreaking approach involves utilizing mRNA to encode HBV-specific TCR in patients' T cells, enabling the targeting of HBV epitopes expressed in liver cancer cells. Positive clinical trial outcomes attest to its efficacy. Building on their mRNA technology and AI-enabled TCR discovery platforms, Lion TCR extends its focus to solid tumors, offering personalized cell therapy and 'off-the-shelf' solutions. This positions Lion TCR to develop a robust pipeline for diverse solid cancers and chronic viral diseases. Learn more at liontcr.com. MaxCyte Contacts: US IR Adviser Gilmartin Group David Deuchler, CFA +1 415-937-5400 ir@maxcyte.com US Media Relations Spectrum Seismic Collaborative Valerie Enes +1 408-497-8568 venes@spectrumscience.com Nominated Adviser and Joint Corporate Broker Panmure Gordon Emma Earl / Freddy Crossley Corporate Broking Rupert Dearden +44 (0)20 7886 2500 UK IR Adviser ICR ConsiliumMary-Jane Elliott Chris Welsh +44 (0)203 709 5700maxcyte@consilium-comms.com Lion TCR Contacts:2 Tukang Innovation Grove#09-04Singapore 618305 +65 68130738