• Clinical trial interim results of SCG101 shows tumour control with lesion shrinkage observed in two out of three patients with advanced HBV-related HCC
• Results show rapid and significant serum HBsAg reduction indicates signal of antiviral activity
• Data presented support the advancement of SCG101 to Phase 1/2 of the clinical trials globally

SINGAPORE, June 23, 2022 /PRNewswire/ -- Singapore-based SCG Cell Therapy Pte Ltd ("SCG") today announced interim data from an investigator-initiated clinical trial of SCG101, which included data evaluating single dose SCG101 in patients with advanced hepatitis B (HBV) related hepatocellular carcinoma (HCC). The data showed significant antiviral activity and tumour control in two of three patients. This set of data was presented at the International Liver Congress (ILC) 2022 Annual Meeting in London on 23 June.

In the three HLA-A*02:01-positive patients with advanced HBV-related HCC who had received at least two prior cancer therapies, the tumour growth was controlled in two out of three patients with lesion shrinkage observed. In addition, there is rapid and significant serum HBsAg reduction observed in both subjects from a baseline of 1,004.3 IU/mL and 521.6IU/ML to 23.8 IU/mL and 9.1 IU/mL in just 28 days from SCG101 treatment and further reduced to 14.0 IU/m and 0.3 IU/mL within 60 days from treatment.

"These data showed encouraging antiviral activity and tumour control by a unique T cell receptor (TCR) therapeutic targeting hepatitis B surface antigen (HBsAg) which provides the first clinical proof-of-concept," said Prof. Dr Ulrike Protzer, Director of the Institute of Virology at Helmholtz Munich and Technical University of Munich and Scientific Founder of SCG. "These early results support the continued development of SCG101 for patients with HBV-associated hepatocellular carcinoma where we see a high unmet medical need."

The safety profile of SCG101 was consistent with the side effects expected in T cell therapy. There was no neurotoxicity observed and also no treatment-related AE or SAE (Adverse Event or Serious Adverse Event) which led to treatment discontinuation. Treatment-related cytokine release syndrome (CRS) with fever and bloating were observed in all three patients. Transient ALT and AST increase, without bilirubin elevation or clinical symptoms, was observed but expected due to SCG101 mechanisms of target cells clearance.

"The results of SCG101 show for the first time that an HBsAg directed TCR T cell therapy can provide dual benefit of antiviral and tumour control to patients with HBV-related HCC," said Shunda Du, MD, hepatologist, Peking Union Medical College and principal investigator for the trial. "Chronic HBV infection accounts for more than half of all patients with liver cancer worldwide. The development of HBV-directed TCR therapeutic prompts us to reconsider hepatitis B as a factor in diagnosis and treatment planning for patients with liver cancer."

"We're proud to collaborate with our partnered hospitals to deliver the world's first clinical proof of concept for TCR T cell therapy targeting HBV, which we believe validates the strength of our platform and opens doors for us to explore further breakthrough discoveries for the treatment of other cancers and diseases with high unmet need," said Dr Ke Zhang, Chief Scientific Officer of SCG.

SCG101 was granted clinical trial approvals by China National Medical Products Administration (NMPA) and Singapore Health Science Authority (HSA) in May 2022. It is the first TCR-T cell therapy product approved by the NMPA for the treatment of HCC and the first multi-country clinical trial approval across China and Singapore in the field of cell therapy. 

About SCG101

SCG101, an autologous T-cell receptor (TCR) T cell therapy, is an investigational cell therapy product that targets specific epitopes of hepatitis B surface antigen (HBsAg). SCG101 incorporates SCG's proprietary technology, which allows for redirecting and engineering endogenous T cells using virus-specific TCRs with high sensitivity and avidity selectively against dysfunctional infected and tumour cells. Preclinical studies of SCG101 demonstrated tumour inhibition and HBV cccDNA eradication. In 2022, SCG101 was granted clinical trial approvals by the China National Medical Products Administration (NMPA) and Singapore Health Science Authority (HSA) for the potential treatment of HBV-related HCC. The Phase 1/2 study evaluating SCG101 is underway.

About Liver Cancer

Hepatocellular carcinoma (HCC) is the most common type of liver cancer. It is estimated more than 905,000 new cases of liver cancer and more than 830,100 deaths from the disease globally in 2020, making it one of the leading causes of cancer deaths around the world ^[1]. Chronic hepatitis B virus (HBV) infection accounts for at least 50% of cases of HCC worldwide ^[2]. HCC is typically diagnosed at an advanced stage and is associated with a poor prognosis. The five-year survival rate of less than 15%.

About SCG Cell Therapy

SCG is a leading biotechnology company focusing on the development of novel immunotherapies for infections and their associated cancers. The company targets the most common cancer-causing infections: helicobacter pylori, human papillomavirus, and hepatitis B, and develops a broad and unique pipeline of T cell therapies, antibodies, and therapeutic vaccines against infections to prevent and cure its associated cancers. Established and headquartered in Singapore, SCG combines regional advantages in Singapore, China and Germany, covering the entire value chain from innovative drug research and discovery, manufacturing, clinical development and commercialization. SCG collaborates with leading scientists and researchers to bring first-in-class and best-in-class medical products/technologies to enhance innovation in medical product development.

For more information about SCG, please visit us at www.scgcell.com

[1]https://www.wcrf.org/cancer-trends/liver-cancer-statistics/

[2]https://pubmed.ncbi.nlm.nih.gov/29052129/#:~:text=Hepatocellular%20carcinoma%20(HCC)%20is%20the,persons%20with%20chronic%20HBV%20infection

SOURCE SCG