Pharma Focus Asia

EASL Wrap-up Session Unveils Late-Breaking Data on SCG101: Innovative HBV-Specific TCR T Cell Therapy Boosts Survival in HBV-Associated Liver Cancer

Saturday, June 08, 2024

SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company, is developing innovative immunotherapies for infectious diseases and their related cancers. The company recently presented clinical data on its first-in-class autologous hepatitis B virus (HBV)-specific T-cell receptor-engineered T Cell (TCR T) therapy, SCG101. This data was featured in a late-breaking session at the European Association for the Study of the Liver (EASL) Congress 2024 in Milan, Italy, and was highlighted in the Best of EASL Congress Wrap-Up, showcasing significant advancements and potential future trends in the field.

Initial results from SCG101's first clinical trial in humans demonstrate encouraging dual antiviral and antitumor effects in patients with advanced HBV-related hepatocellular carcinoma (HCC). In this trial, involving six patients treated with doses ranging from 5.0×107 to 1.0×108 TCR+ T cells per kilogram, the therapy achieved an objective response rate of 33%. Patients who experienced partial responses maintained remission for over six months, and one patient showed complete remission of the target lesion, remaining progression-free for 27 months.

The therapeutic effects on tumors were closely tied to the antiviral actions of SCG101. Four out of six patients (67%) showed a significant reduction in serum HBsAg levels by 1 to 4 log10 following a single infusion of SCG101. These HBsAg levels stayed at or below 15 IU/mL throughout the follow-up period, which extended up to 27 months. Tumor reduction was observed in all patients who had a reduction in HBsAg of at least 1 log10, with median progression-free survival and overall survival significantly improved (mPFS: 5.9 vs 0.7 months, mOS: 19.0 vs 6.3 months) in these patients compared to those without such a reduction.

The safety profile of SCG101 was generally favorable, with no reports of severe adverse events or immune effector cell-associated neurotoxicity syndrome. The most common side effects were mild and included temporary increases in liver enzymes, cytokine release syndrome, and fever, which are expected given the therapy's mechanism of targeting HBsAg-expressing cells.

HBV infection is a significant cause of liver cancer, responsible for 50%-80% of HCC cases globally. The virus integrates into the host DNA, leading to genetic instability and epigenetic changes, which cause abnormal expression of oncogenes and HBV antigens. SCG101 specifically targets HBV peptides presented on tumor cells, premalignant hepatocytes, and HBV-infected cells, using both cytolytic and non-cytolytic mechanisms to eliminate these cells.

"We are excited about the positive outcomes demonstrated in the EASL Wrap-up session, which highlighted SCG101's promising dual antiviral and antitumor activities, sustained reduction in HBsAg levels, and extended progression-free and overall survival in patients with HBV-HCC," said Christy Ma, CEO of SCG Cell Therapy. "These results reinforce the potential of our GianTCRTM platform to develop effective TCR-based therapies across multiple therapeutic areas, particularly for treating infectious diseases and related cancers. We are eager to further explore SCG101 and other TCR candidates to address significant unmet needs in patient care."

SCG101 is an investigational autologous T-cell receptor (TCR) T cell therapy targeting a specific epitope of the hepatitis B surface antigen (HBsAg). Utilizing SCG's proprietary GianTTM technology, it identifies TCRs with high affinity and avidity against intracellular antigens presented via the major histocompatibility complex (MHC) in solid tumors. Preclinical and clinical studies have demonstrated SCG101's ability to inhibit tumors and eliminate HBV cccDNA. SCG101 has received clinical trial approvals from the U.S. Food and Drug Administration (FDA), China National Medical Products Administration (NMPA), Singapore Health Science Authority (HSA), and Hong Kong Department of Health (DOH) for the treatment of HBV-related HCC. A Phase 1/2 clinical trial of SCG101 is currently underway (NCT05417932).

Hepatocellular carcinoma (HCC) is the most common type of liver cancer. It is estimated that globally there were over 905,000 new cases and more than 830,100 deaths from liver cancer in 2020, making it one of the leading causes of cancer death worldwide. Chronic HBV infection accounts for at least 50% of HCC cases globally. Typically diagnosed at an advanced stage, HCC has a poor prognosis, with a five-year survival rate of less than 15%.



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