SCG Cell Therapy Pte. Ltd.

SINGAPORE, June 30, 2024 /PRNewswire/ -- SCG Cell Therapy Pte Ltd (SCG), a biotechnology company developing novel immunotherapies for infectious diseases and their associated cancers, today announced that U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to initiate Phase 1/2 clinical trial for SCG142, a novel next-generation human papillomavirus (HPV) E7-specific T-cell receptor-engineered T (TCR T) cell therapy for patients with HPV-associated solid tumors. "This FDA IND approval of another TCR T cell therapy candidate generated from our proprietary GianTCRTM platform is an important milestone for SCG. It marks the advancement of our TCR-based therapeutic program to treat unmet needs in different major cancer indications", said Christy Ma, Chief Executive Officer of SCG Cell Therapy. "We are ready to commence multi-center Phase 1/2 clinical trials, assessing the potential benefits for patients via our proprietary TCR T technology." SCG142 is a high-avidity fully natural HPV-specific TCR armoured with a TGFβRII-41BB chimeric switch receptor. In May 2024, SCG presented preclinical data of SCG142 at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting. The data indicates SCG142 had exhibited high polyfunctional avidity. It recognized both HPV-16 and HPV-52 genotypes, with a favourable safety profile with no alloreactivity or off-target toxicity. In addition, SCG142 demonstrated dual CD8 and CD4 TCR T cell proliferation and tumor inhibition in both in vitro and in vivo models, indicating CD8 co-receptor independent T cell functionality, as well as promoting long-term persistence of memory T cells. "SCG142 is a novel and differentiated HPV-specific TCR T cell therapy. By armoring the TCR T cells with the chimeric switch receptor, it overcomes the hostile tumor microenvironment and converts inhibitory effects into a co-stimulatory signal. This process is essential for effective immunotherapy treatment of solid tumors. With this unique next-generation design, SCG142 represents a groundbreaking innovation that translates from our in-house discovery platforms into clinics", said Dr. Ke Zhang, Chief Scientific Officer of SCG Cell Therapy. – END – About Human Papillomavirus and Cancers Human papillomavirus (HPV) is the most common sexually transmitted infection. Nearly all sexually active people will be infected with HPV at some point in their lives. Approximately half of these infections are with a high-risk HPV type, which can lead to cancer[1]. HPV infection accounts for more than 90% of anal and cervical cancers, about 70% of vaginal and vulvar cancers, and 60% of penile and oropharynx cancers. An estimated 630,000 new cancer cases and 350,000 deaths worldwide each year are resulted from HPV (related) infection.[2] 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 infections associated cancers. With the proprietary GianTCRTM novel TCR screening platform and AutocellTM fully closed and automatic cell therapy manufacturing system, the company covers the entire value chain, 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

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

SINGAPORE, May 12, 2024 /PRNewswire/ -- SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company developing novel immunotherapies for infectious diseases and their associated cancers, announced first preclinical data of its novel human papillomavirus (HPV)-specific T cell receptor-engineered T (TCR T) cell therapy armored with an TGFβRII-41BB immunoswitch – SCG142 – in an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting in Baltimore, Maryland. In preclinical studies, SCG142 demonstrated superior CD8+ and CD4+ TCR T cell proliferation and tumor inhibition both in-vitro and in-vivo compared to conventional TCR T without immunoswitch, including tumor rechallenge models. Importantly, SCG142 functionality is CD8 co-receptor independent, transferring desired effector functions also to CD4+ T cells and promoting longer persistence and improved proliferation of T cells. In addition, SCG142 exhibited high functional avidity and can recognize both genotypes HPV-16 and HPV-52, with a favorable safety profile with no alloreactivity or off-target toxicity in relevant toxicology models. "SCG142 is a novel and differentiated HPV-specific TCR T cell therapy with preclinical efficacy in various tumor types with expression of HPV-16- and HPV-52 genotypes. We're excited to demonstrate that armoring the TCR-T cells with the chimeric switch receptor didn´t change the favorable safety profile but helped to overcome the immune inhibitory signal of TGF-β, which can be crucial for effective treatment of solid tumors", said Dr. Susanne Wilde, Head of Preclinical Research of SCG Cell Therapy. "These promising results underscore the potential of SCG142 to provide new solutions for patients in a variety of HPV-16- and HPV-52 expressing cancers. Based on these encouraging data, we are eagerly advancing SCG142 towards clinical trials", she added. About SCG142 SCG142, an autologous HPV-specific TCR T cell therapy holding the promise as the best-in-class product. Utilizing SCG's proprietary GianTCRTM technology, high affinity and high avidity natural TCRs can be isolated to target against intracellular antigens presented through major histocompatibility complex (MHC) in solid tumors. Study results showed that SCG142, a fully natural HPV specific TCR armoured with chimeric switch receptor, has the potential to specially target HPV-16 and HPV-52-positive tumor cells in various HPV-related tumor types, generating CD8 co-receptor independent T cell functionality and sustained anti-tur activity. About Human Papillomavirus and Cancers Human papillomavirus (HPV) infection is the most common sexually transmitted infection. Nearly all sexually active people are infected with HPV and around half of these infections occur with a high-risk HPV type, which can lead to cancer development.1 As such, HPV infection accounts for more than 90% of anal and cervical cancers, about 70% of vaginal and vulvar cancers, and 60% of penile and oropharyngeal cancers, and it causes an estimated 630,000 cancers worldwide each year2x. 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 from new target research and discovery, manufacturing, and clinical development. For more information about SCG, please visit us at . [1] HPV and cancer. National Cancer Institute. (2023, October 18) [2] Basic information about HPV and cancer. Centers for Disease Control and Prevent (2023, September 12) SOURCE SCG Cell Therapy Pte Ltd