SCG Cell Therapy Presents Promising Phase 1 Data for a Novel HBV-Specific TCR-T Therapy (SCG101) at the AASLD Liver Meeting 2024

November 25, 2024 01:01 PM NZDT | By Cision
Follow us on Google News: https://kalkinemedia.com/resources/assets/public/images/google-news.webp
 SCG Cell Therapy Presents Promising Phase 1 Data for a Novel HBV-Specific TCR-T Therapy (SCG101) at the AASLD Liver Meeting 2024
Image source: Kalkine Media

SINGAPORE, Nov. 25, 2024 /PRNewswire/ -- 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 5.0×107 ~ 1.0×108 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 log10, 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 GianTTM 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 GianTTM 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.

 


Disclaimer

The content on this website, including, but not limited to, any articles, news, quotes, information, data, text, reports, ratings, opinions, images, photos, graphics, graphs, charts, animations, and video (“Content”) is a service provided by Kalkine Media New Zealand Limited, Company Number 8107196 and NZBN 9429018590709 (“Kalkine Media, we or us”) and is available for personal and non-commercial use only. The principal purpose of the Content is to educate and inform. The Content does not contain or imply any recommendation or opinion intended to influence your financial decisions and must not be relied upon by you as such. Some of the Content on this website may be sponsored/non-sponsored, as applicable, but is NOT a solicitation or recommendation to buy, sell or hold the stocks of the company(s) or engage in any investment activity under discussion. Kalkine Media is neither licensed nor qualified to provide financial advice through this platform. Users should make their own enquiries about any investments and Kalkine Media strongly suggests users seek financial advice from a financial advice provider, stockbroker or other professional (including taxation and legal advice), as necessary. Kalkine Media hereby disclaims any and all liability to any user for any direct, indirect, implied, punitive, special, incidental or other consequential damages arising from any use of the Content on this website, which is provided without any express or implied warranties of any kind. The views expressed in the Content by the guests, if any, are their own and do not necessarily represent the views or opinions of Kalkine Media.
The content published on Kalkine Media also includes feeds sourced from third-party providers. Kalkine does not assert any ownership rights over the content provided by these third-party sources. The inclusion of such feeds on the Website is for informational purposes only. Kalkine does not guarantee the accuracy, completeness, or reliability of the content obtained from third-party feeds. Furthermore, Kalkine Media shall not be held liable for any errors, omissions, or inaccuracies in the content obtained from third-party feeds, nor for any damages or losses arising from the use of such content. Some of the images/music that may be used on this website are copyrighted to their respective owner(s). Kalkine Media does not claim ownership of any of the pictures displayed/music used on this website unless stated otherwise. The images/music that may be used on this website are taken from various sources on the internet, including paid subscriptions or are believed to be in public domain. We have used reasonable efforts to accredit a source wherever it is indicated or is found to be necessary or desirable.

This disclaimer is subject to change without notice. Users are advised to review this disclaimer periodically for any updates or modifications.

Recent Articles

We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.