SCG101, the World’s First HBsAg-Targeting TCR-T Therapy, Achieves Clinical Proof-of-Concept in HBV-Related Liver Cancer at ILC 2022

World's First Targeted HBsAgCell Therapy Achieves Clinical Proof of Concept

ShanghaiJune 23, 2022PR Newswire -- On June 23, at the 57th Annual Meeting of the European Association for the Study of the Liver (EASL) and the International Liver Congress (ILC 2022) held in London, Singapore's innovative biopharmaceutical company, SCG Cell Therapy Pte. Ltd., announced for the first time the latest clinical trial research on SCG101 for the treatment of patients with hepatitis B virus-related hepatocellular carcinoma. The preliminary data showed that SCG101 demonstrated good safety and initial efficacy in advanced hepatitis B virus-related liver cancer patients who lack effective treatment options; the study indicated that SCG101 has significant antiviral and antitumor activity, with rapid and sustained reduction in serum HBsAg, achieving a disease control rate of 66%.

As the worldLeadingThe European Association for the Study of the Liver (EASL), hosts its annual conference – the International Liver Congress (ILC) – which is considered one of the most authoritative and influential international meetings in the field of hepatology worldwide. The event attracts tens of thousands of professionals and top liver disease research teams from over 100 countries each year. This year, the ILC accepted 1,993 research abstracts from around the globe, and SCG Cell Therapy Pte. Ltd. presented the clinical research data of its SCG101 at the conference.

According to the published content, SCG101 is a T-cell receptor cellular therapy (TCR-T) drug developed by SCG Cell Therapy Pte. Ltd., targeting hepatitis B surface antigen (HBsAg). The research showed that among three HLA-A*02:01 positive patients with advanced hepatitis B virus-related hepatocellular carcinoma who had received at least two rounds of anti-tumor treatments, significant tumor shrinkage was observed, achieving a disease control rate of 66%. Within 28 days after SCG101 treatment, serum HBsAg levels in two subjects decreased by >1.7 log10 IU/mL, rapidly and significantly dropping from baseline levels of 1004.3 IU/mL and 521.6 IU/mL to 23.8 IU/mL and 9.1 IU/mL, respectively, and further declining to 14.0 IU/mL and 0.3 IU/mL by day 60 post-treatment. The study results demonstrated that the safety profile of SCG101 was consistent with its known mechanism; no neurotoxicity was observed, and no treatment-related adverse events (AE) or serious adverse events (SAE) led to treatment discontinuation.

As the inventor of SCG101, Professor Ulrike Protzer, the scientific founder of SCG Cell Therapy Pte. Ltd., expressed great delight, stating that this is a significant milestone for TCR-T cell therapy in the field of virus-related solid tumors. It marks the world's first clinical proof-of-concept for HBsAg-targeted cell therapy. This clinical study has conducted a highly positive and meaningful exploration in the field of innovative immunotherapy for liver cancer, demonstrating preliminary antiviral and antitumor activity, which is undoubtedly an encouraging development for patients with liver cancer.

Professor Du Shunda, a hepatobiliary surgery expert from Peking Union Medical College Hospital and the principal investigator of the project, stated that China has a high incidence of liver cancer, with the number of cases accounting for nearly half of the global total. More than 80% of liver cancer cases are associated with hepatitis B virus infection. The clinical research results of SCG101 have, for the first time, demonstrated that TCR-T cell therapy targeting HBsAg can bring dual benefits to patients with hepatitis B virus-related liver cancer. This further highlights hepatitis B infection as an important consideration in the diagnosis and treatment of liver cancer.

Mr. Wang Shuli, Co-founder and CEO of SCG Cell Therapy Pte. Ltd., stated that since its establishment, SCG has been committed to developing novel targeted immunotherapies for chronic infections and their associated cancers, aiming to achieve "HBV elimination and liver cancer prevention." SCG101, the world's first TCR-T cell therapy targeting HBsAg, has obtained clinical proof of concept. The positive results demonstrated in its clinical data give us confidence that SCG101, with its unique mechanism, shows promising efficacy and provides a new treatment option for liver cancer patients in China and around the world. The goal of "HBV elimination and liver cancer prevention" will be achieved through more extensive and in-depth clinical research.

As SCG Cell Therapy Pte. Ltd.Key PointsProduct SCG101 embarked on its globalization journey in 2022, simultaneously receiving approval for clinical trial applications (IND) from China’s National Medical Products Administration (NMPA) and Singapore’s Health Sciences Authority (HSA). It became the first TCR-T cell therapy product approved by the NMPA for the treatment of liver cancer.