Introduction

SINGAPORE, Nov. 25, 2024 – SCG Cell Therapy Pte Ltd, a pioneering biotechnology company specializing in advanced immunotherapies for infectious diseases and their linked cancers, has announced remarkable findings from its Phase 1 trial of SCG101, a novel autologous T-cell receptor (TCR) therapy focusing specifically on the hepatitis B virus (HBV). These exciting results were disclosed at the renowned 2024 AASLD Liver Meeting held in San Diego, California.

Phase 1 Trial Results

The Phase 1 clinical trial demonstrated encouraging antiviral effects among patients suffering from advanced HBV-related hepatocellular carcinoma (HBV-HCC). In a study involving 12 patients who received a single intravenous infusion of SCG101—ranging from 5.0×10^7 to 1.0×10^8 TCR+ T cells/kg—results showed a substantial decrease in serum HBsAg levels. Remarkably, 11 out of the 12 patients (92%) experienced a reduction between 1.0 to 4.6 log10, with these levels remaining below 100 IU/mL throughout the year-long follow-up period. Most impressively, four patients (33%) achieved complete HBsAg loss within just 21 days post-infusion, a status that remained sustained during the follow-up.

Safety Profile

The safety profile for SCG101 was largely positive, with the therapy showing good tolerance among patients. Common treatment-related adverse events included mild to transient elevations in liver enzymes, fever, cytopenia, cytokine release syndrome (CRS), alongside changes in albumin and sodium levels. These side effects were consistent with the adaptive immune response triggered by SCG101 as it targets HBsAg to eliminate not just infected hepatocytes but also malignant HBV-HCC cells.

Global Health Impact

With over 250 million individuals worldwide infected with HBV, this virus remains a critical global health concern and ranks among the leading causes of liver cancer, accounting for between 50% to 80% of hepatocellular carcinoma cases globally. Chronic HBV infections cause the integration of viral DNA into host genomes, leading to persistent HBsAg expression and contributing to the oncogenic processes that further complicate liver health. SCG101 is innovative in that it aims to selectively target HBV-infected cells, thereby engaging both cytolytic and non-cytolytic mechanisms crucial for the elimination of diseased cells.

CEO's Statement

Christy Ma, CEO of SCG Cell Therapy, remarked, "The encouraging outcomes from our Phase 1 trial mark a pivotal moment in the journey of SCG101, our first-in-class TCR T cell therapy tailored for HBV. These results not only highlight the potential for SCG101 to offer meaningful antiviral responses in patients but also emphasize the groundbreaking approach we are taking in the world of antiviral cancer therapy. We are excited to advance SCG101 into further clinical development to provide new opportunities for those battling this complex disease."

Future Potential

SCG101 aims to address not only hepatitis B-related complications but also hold the promise of extending its capabilities to other viral infection-associated cancers, such as those caused by human papillomavirus (HPV) and Epstein-Barr virus (EBV), potentially revolutionizing the landscape of immune-based cancer treatments.

Urgency for New Therapies

As the world grapples with staggering statistics surrounding liver cancer—over 905,000 new cases and more than 830,100 deaths in 2020 alone—initiatives like SCG101 are crucial in overcoming the current challenges faced in HCC management. With a five-year survival rate lingering below 15%, the urgency for groundbreaking therapies has never been more clear.

Current Trials

The Phase 1/2 trial for SCG101 is currently underway, backed by regulatory approvals from global health authorities including the FDA, NMPA, and Hong Kong Department of Health, reflecting strong support for innovative therapeutic pathways in the fight against HBV and its cancerous repercussions.

Conclusion

Stay tuned as SCG Cell Therapy takes bold steps forward in the quest for a transformative solution to a pressing global health crisis!