SCG Cell Therapy to Present Late-Breaking Data at the International Society for Cell & Gene Therapy (ISCT) Highlighting Promising Antitumor and Antiviral Activities of SCG101 in Treating HBV-Related Hepatocellular Carcinoma

SINGAPORE,April 24,2023 -- Singapore based SCG Cell Therapy Pte Ltd (SCG),a clinical-stage biotechnology company developing novel immunotherapies for infectious diseases and their associated cancers,today announced that late-breaking data from the company's TCR-T therapy pipeline – SCG101,will be presented at the International Society for Cell & Gene Therapy (ISCT) in Paris,France on 1 June.

"These exciting new data being presented at ISCT continue to reinforce the potential for viral antigen specific TCR-T product to effectively treat infection-associated solid tumour indications like HBV-related hepatocellular carcinoma," said Frank Wang,Chief Executive Officer of SCG Cell Therapy. "The clinical data shows exceptional efficacy of this novel TCR-T cell therapy. Thus far,SCG101 has shown to produce robust and durable anti-tumour and antiviral responses and we look forward to providing additional updates on this program as the trial progresses."

SCG101 is an autologous TCR-T cell therapy targeting specific hepatitis B surface antigen (HBsAg) epitopes. The late-breaking data to be presented at ISCT demonstrated positive efficacy of SCG101 as a monotherapy in patients with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC),achieving partial response (PR) after a single dose of SCG101 with durable tumour response observed. Serum HBsAg significantly decreased and the expression of HBsAg in hepatocyte dropped to undetectable.

In June 2022,SCG Cell Therapy presented the first clinical proof-of-concept data demonstrating the mechanism of action of a HBsAg-specific TCR-T cell therapy,SCG101,at the International Liver Congress (ILC) 2022. The data showed precise target engagement and cell proliferation,and demonstrated antiviral activity and tumour control. Sixty-six percent of patients with advanced HBV-related HCC observed lesion shrinkage as well as significant serum HBsAg reduction (> 2 log) within 28 days from single dose monotherapy SCG101 treatment.

Presentation Details:

Title:Infected hepatocyte clearance and sustained tumour regression by first-in-class HBsAg-specific TCR-T (SCG101) therapy for HBV-related HCC

Presenter:1093

Abstract Number:3907176

Date and Time:1 June,2023

About SCG101

SCG101,an autologous T-cell receptor (TCR) T cell therapy,is an investigational cell therapy product targeting specific epitopes of hepatitis B surface antigen (HBsAg). Utilizing SCG's proprietary GianT™technology,high affinity and high avidity natural TCR can be identified against intracellular antigens expressed through major histocompatibility complex (MHC) in solid tumours. Preclinical studies of SCG101 demonstrated tumour inhibition and HBV cccDNA eradication. SCG101 was granted clinical trial approvals by the U.S Food and Drug Administration (FDA),China National Medical Products Administration (NMPA) and Singapore Health Science Authority (HSA) for patient with HBV-related HCC. A Phase 1/2 clinical trial evaluating SCG101 is ongoing.

About Hepatocellular carcinoma

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 in infections and its 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 and 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. For more information about SCG,please visit us at www.scgcell.com.

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

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