Singapore’s SCG, HSA to develop novel treatment for Hepatitis B-related cancer

Biotechnology company SCG Cell Therapy Pte Ltd (SCG) is to collaborate with the Cell Therapy Facility of Singapore Health Sciences Authority (HSA-CTF) for the evaluation and validation of SCG’s proprietary cell therapy manufacturing process, SCG101 – the agreement between the two parties will see to the development of a new treatment option for patients with Hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC).

The process validation will be performed in the Good Manufacturing Practice (GMP)-certified facility at HSA-CTF, and procedures will be fully compliant to current GMP (cGMP) requirements. SCG also intends to utilise the validation result to support global Investigational New Drug (IND) Application of SCG101 – autologous T-cell receptor (TCR) T cell therapy.

“HSA-CTF has a proven track record of cell therapy product manufacture, and their staff are well-versed in the stringent cell manufacturing processes under cGMP requirements. This will allow us to ensure a high-quality standard of our T cell therapy product,” said Frank Wang, Chief Executive Officer of SCG.

HCC, especially associated with HBV, remains a major cause of cancer-linked mortality worldwide. In 2018, the estimated annual incidence and mortality increased to 841,000 cases and 782,000 deaths respectively, with the highest HCC incidence rates found in East and Southeast Asia. HCC is typically diagnosed late in its course; treatment options are limited and overall prognosis for survival is poor, with a five-year relative survival rate of only 12%.

Cell therapy as a treatment option is one of the most promising for such cancers: as cell-based therapy involves growing and expansion of living cells, a reproducible and high-quality manufacturing process is essential.

“We are excited to partner with SCG in their pioneering work on novel cell therapies. With our expertise in GMP compliant cell products manufacturing, we are confident that we can accelerate the access of these treatments to patients in Singapore and around the world. We look forward to providing this new field of treatment to help patients,” said Dr. Marieta Chan, Facility Director of HSA-CTF.

SCG’s proprietary cell therapy manufacturing process employs sophisticated closed and automated technologies which eliminates the expansive clean room and the labour-intensive manual manufacturing steps. The process has been validated in SCG’s cell therapy manufacturing site in Shanghai, China and is currently being supplied for clinical trials.

The collaboration with HSA is in line with SCG’s plans to establish Singapore as an international hub for cell therapy research, manufacturing, and clinical development.

“Singapore is an attractive location to set up an international hub with its world-class research and manufacturing infrastructures, GMP-certified manufacturing talent and openness to embrace modern technologies. With the technology transferred and validated in Singapore, we look forward to establishing SCG’s international hub of cell therapy research, manufacturing, and clinical development in the country to deliver high-quality products of our broad cell therapy pipeline worldwide,” said Frank.

“I am excited by this collaboration between HSA and SCG, and the prospect of developing a novel treatment for patient use in targeting this cancer. This partnership underscores the importance Singapore has placed on the future and promise of cell-based medicine and provides a great opportunity for HSA to validate a highly specialised cell-based manufacturing process that conforms to international regulatory requirements,” added Dr. Mickey Koh, Medical Director of HSA-CTF.

Category: Community, Features