• SCG101 is the first TCR-T cell therapy product to receive a multi-regional Investigational New Drug (IND) approval from Singapore's Health Sciences Authority (HSA) and China's National Medical Products Administration (NMPA) for the treatment of HCC
• APAC accounts for four in five new cases of liver across globally
• The global T-cell therapy market expected to reach USD20.3 billion by 2028

Singapore-based SCG Cell Therapy Pte Ltd ("SCG"), a leading biotechnology company, today announces that Singapore's Health Sciences Authority (HSA) has cleared the company's Investigational New Drug (IND) application for clinical trials for SCG101 – an autologous T-cell receptor (TCR) T-cell therapy. SCG101 is being developed to treat hepatitis B virus (HBV) related hepatocellular carcinoma (HCC) – the most common form of liver cancer.

The treatment has recently secured IND approval from China's National Medical Products Administration (NMPA), making it the first TCR-T cell therapy product approved by the NMPA for the treatment of HCC and the first multi-regional IND approval in the field of cell therapy across Singapore and China.

"The multi-country IND approval for SCG101 is a key milestone for SCG's cell therapy pipeline, proving our capability to fulfil regulatory requirements in the target markets", said Frank Wang, Chief Executive Officer of SCG Cell Therapy. "Globally, liver cancer has the second-highest cancer-mortality rate accounting for over 700,000 deaths each year. Four in five new HCC cases are diagnosed in the Asia Pacific. Singapore is known as a medical centre of excellence in Southeast Asia and is one of the world's top medical tourism destinations. This milestone pushes forward our mission to advance cell therapy to patients in need and strengthens our position as a key global player", Frank added.

"In Singapore, liver cancer is the third most common cause of cancer-related death. There are significant challenges with the available treatment options in meeting patient needs. SCG101 offers a novel treatment option for patients," said Dr Yong Wei Peng, Principal Investigator of the study and Senior Consultant at the Department of Haematology-Oncology at the National University Cancer Institute, Singapore.

"Cell therapy is one of the most promising and rapidly advancing treatments for chronic and life-threatening diseases such as cancer. SCG101, an individualised cancer treatment which is manufactured locally at Cell Therapy Facility of Singapore Health Sciences Authority (HSA-CTF), offers potential new hope to such cancer patients in Singapore," said Dr Toh Han Chong, Principal Investigator at National Cancer Centre Singapore.

According to Grand View Research, the global T-cell therapy market is expected to reach USD 20.3 billion by 2028, expanding at a CAGR of 20.2% from 2021 to 2028.

With SCG101, the function of T-cells is activated by recognising peptide fragments - short chains of amino acids - of pathogen-derived proteins in the form of complexes of peptides and MHC molecules (major histocompatibility complex) on the cell surface via the TCR. SCG101 specifically recognises the epitope of the hepatitis B virus surface antigen (HBsAg), which redirects T-cells specificity against the HBV antigens. With the specific HLA typing, SCG101 can recognise both HBsAg membrane antigen and HBsAg intracellular antigen. Therefore, SCG101 eliminates HBsAg-positive HCC cells and also eradicates HBV cccDNA (covalently closed circular DNA).

T-cells are important white blood cells of the immune system and play a central role in the adaptive immune response. TCRs are molecules on the surface of T-cells that allow the immune system to distinguish the body's own healthy cells from diseased pathogen-infected or tumour cells.

In November 2021, SCG Cell Therapy announced a collaboration with the Cell Therapy Facility of Singapore's Health Sciences Authority (HSA-CTF) for the evaluation and validation of SCG's proprietary cell therapy manufacturing process for the development of new treatment options for patients with HBV related HCC.

The validation process of SCG101 was performed in the Good Manufacturing Practice (GMP)-certified facility at HSA-CTF and is fully compliant with current GMP (cGMP) requirements.