SINGAPORE, May 9, 2022 /PRNewswire/ -- Singapore-based SCG Cell Therapy Pte Ltd (“SCG”), a leading biotechnology company, has announced that the clinical trial application for SCG101 – an autologous T-cell receptor (TCR) T cell therapy has been approved in Singapore.
SCG101 is being developed to treat hepatitis B virus (HBV) related hepatocellular carcinoma (HCC) – the most common form of liver cancer. The treatment recently secured IND approval from China’s National Medical Products Admiistration (NMPA), making it the first TCR-T cell therapy product approved by the NMPA for the treatment of HCC and the first multi-country clinical trial approval in the field of cell therapy.
“The multi-country clinical trial approval for SCG101 is a key milestone for SCG’s cell therapy pipeline, proven 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 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 one of the 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 at National University Cancer Institute.
“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 the Cell Therapy Facility (CTF) of Singapore’s Health Sciences Authority (HSA), offers new hope to patients in Singapore,” said Dr Toh Han Chong, Principal Investigator at National Cancer Centre Singapore.
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 tumor cells.
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 recognizes 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 recognize both HBsAg membrane antigen and HBsAg intracellular antigen. Therefore, SCG101 eliminates targets HBsAg-positive HCC cells and also eradicates HBV cccDNA (covalently closed circular DNA).
In November 2021, SCG Cell Therapy announced a collaboration with the Cell Therapy Facility(CTF) of Singapore’s HSA 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 of SCG 101 processes was performed in the Good Manufacturing Practice (GMP)-certified facility at HSA-CTF in accordance with GMP requirements.
Dr Mickey Koh, Programme Director at CTF said, “I am pleased that we have successfully validated SCG’s manufacturing process and very much look forward to be the manufacturer of this novel cell therapy product for the upcoming clinical trial. This successful partnership with SCG as well as with both the National Cancer Centre and the National University Cancer Institute will further consolidate the position of CTF as a trusted and fully accredited provider of cell therapy products for clinical translation.
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.
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. 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.
About National Cancer Centre Singapore
National Cancer Centre Singapore (NCCS) provides a holistic and multi-disciplinary approach to cancer treatment and patient care. We treat almost 70 per cent of the public sector oncology cases- and they are benefiting from the sub-specialisation of our clinical oncologists. NCCS is also accredited by the US-based Joint Commission International for its quality patient care and safety. To deliver among the best in cancer treatment and care- our clinicians work closely with our scientists who conduct robust cutting-edge clinical and translational research programmes which are internationally recognised. NCCS strives to be a global leading cancer centre and shares its expertise and knowledge by offering training to local and overseas medical professionals.
About National University Cancer Institute, Singapore
National University Cancer Institute, Singapore (NCIS) offers a broad spectrum of cancer care and management covering both paediatric and adult cancers, with expertise in prevention, screening, diagnosis, treatment, rehabilitation and palliative care. The Institute's strength lies in the multi-disciplinary approach taken to develop a comprehensive and personalised plan for each cancer patient and his or her family. Our award-winning clinician-scientists and clinician-investigators conduct translational research and clinical trials, providing patients with access to evidence-based cancer diagnostics, technology and therapies.
About Health Sciences Authority’s Cell Therapy Facility
The Cell Therapy Facility (CTF) of HSA’s Blood Services Group houses a Good Manufacturing Practice (GMP) facility with a highly trained and skilled specialist team and has been in existence since 2006. It is committed to the development of novel translational cell therapies for treatment of diseases, such as cancer, autoimmune and degenerative diseases. The Facility manufactures cellular products which fulfil international regulatory Good Tissue Practices (GTP) and GMP requirements. A stringent overarching quality programme fully compliant with international regulatory standards ensures a level of consistency and stringency of these manufactured cellular products for safe application to patients. It has successfully partnered both academic and commercial cell therapy companies to deliver innovative cell–based therapy that have demonstrate efficacy and safety.
