#Singapore #SCG101 #SCG Cell Therapy #HBV Treatment

Groundbreaking Clinical Findings from SCG Cell Therapy

SCG Cell Therapy Pte Ltd (SCG), a pioneering biotechnology firm, revealed significant late-breaking clinical data regarding their innovative treatment, SCG101, specifically targeting HBV-related hepatocellular carcinoma (HCC) at the prestigious European Association for the Study of the Liver (EASL) Congress in 2025. This development holds the promise of revolutionizing the treatment landscape for patients battling chronic hepatitis B virus (HBV) infections that lead to HCC, one of the leading causes of cancer-related deaths globally.

Study Overview and Results

SCG101 is an autologous T-cell receptor (TCR) therapy designed to target and eradicate HBV-infected cells and the associated malignancies. The Phase 1 trial intricately examined the therapy’s efficacy in patients who had previously undergone extensive treatment regimens, showcasing notable outcomes. Reports from the trial indicated that a staggering 94% of participants, who had previously been treated with nucleoside analogue antiviral therapies, experienced significant improvement following a single infusion of SCG101.

Within just 28 days post-treatment, 94% of treated individuals noted a marked drop in their serum hepatitis B surface antigen (HBsAg) levels, with a reduction ranging from 1.0 to 4.6 log₁₀. This decrease in HBsAg remained consistent, with levels staying below 100 IU/mL for up to a year. Impressively, 23.5% of the patients achieved complete HBsAg loss after the treatment. Such results highlight the therapy’s potential as a powerful tool in achieving long-term virological responses among difficult-to-treat populations.

In addition to its antiviral capabilities, SCG101 exhibited considerable antitumor activity. In this heavily pre-treated cohort, nearly half of the patients, 47% to be precise, showed measurable tumor regression, demonstrating the dual benefits of this innovative therapy. While the median overall survival (OS) data remains to be defined, the observable trends are encouraging.

Safety Profile and Expert Insights

The safety of SCG101 also contributed favorably to its standing. Most adverse reactions were manageable, with transient elevations in alanine aminotransferase (ALT) being the most frequent issue, appearing in 94% of patients but resolving within a fortnight. Moreover, manageable instances of cytokine release syndrome and blood cell reductions were also reported, further supporting the favorable tolerability profile.

Professor Dr. Shunda Du, Chief of the Liver Surgery Department at Peking Union Medical College Hospital, underscored the relevance of these findings, particularly in a patient demographic that has generally faced grim outcomes due to advanced stages of liver cancer. He remarked on the promising nature of the dual-action approach SCG101 offers—both tackling the viral load while simultaneously addressing tumor behavior.

The Broader Context of HBV and HCC

Chronic HBV infections embody a monumental health challenge, affecting over 250 million individuals worldwide. Representing a significant contribution to the landscape of liver cancers, chronic HBV accounts for 50% to 80% of HCC diagnoses globally. These insights reinforce the urgent need for innovative therapeutic strategies like SCG101, which not only aim at viral suppression but also at tumor management.

Future Directions

Christy Ma, CEO of SCG Cell Therapy, expressed optimism regarding the potentials SCG101 ushers into the healthcare industry, emphasizing its role as a ground-breaking approach in immunotherapy. SCG believes that the data presented at EASL marks a pivotal step in advancing SCG101 into further clinical development phases, aimed at addressing significant unmet needs in the treatment of HBV-related HCC.

The potential benefits of SCG101 could pave the way for countless patients facing this life-threatening disease, representing not only a therapeutic innovation but also a beacon of hope for effective management of HBV-related HCC. As the trials progress, the biotech community will keenly observe the further explorations of this promising treatment option.