SCG Cell Therapy Announces HSA Clinical Trial Approval of TCR-T Cell Therapy for Liver Cancer

  • SCG101 is an autologous T cell receptor (TCR) T cell therapy for liver cancer
  • SCG101 is the first TCR-T cell therapy product to receive multi-regional Investigational New Drug (IND) approval from that of Singapore Health Sciences Authority (HSA) and China National Medical Products Administration (NMPA) for the treatment of HCC
  • APAC accounts for four out of five new liver cases worldwide
  • The Global T Cell Therapy Market is Expected to Reach $20.3 billion by 2028

SINGAPORE, May 9, 2022 /PRNewswire/ — SingaporeSCG Cell Therapy Pte Ltd (“SCG”), a leading biotechnology company, today announces that that of Singapore The 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) therapy. SCG101 is being developed to treat hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC), the most common form of liver cancer.

The treatment recently gained IND approval from China National Medical Products Administration (NMPA), making it the first TCR-T cell therapy product approved by NMPA for the treatment of HCC and the first multi-regional IND approval in the field of cell therapy through Singapore and China.

“The multi-country IND approval for SCG101 is a key milestone for SCG’s cell therapy pipeline, proving our ability to meet regulatory requirements in target markets,” said Frank WangCEO of SCG Cell Therapy. “Globally, liver cancer has the second highest cancer death rate, with more than 700,000 deaths each year. Four out of five new cases of HCC are diagnosed in the Asia Pacific. Singapore is recognized as a medical center of excellence in South East Asia and is one of the world’s leading medical tourism destinations. This milestone advances our mission to advance cell therapy for patients in need and strengthens our position as a key global player,” added Frank.

“In Singapore, liver cancer is the third most common cause of cancer-related death. There are significant challenges with the treatment options available to meet patient needs. SCG101 offers a new treatment option for patients,” said Doctor Yong Wei Pengprincipal investigator of the study and senior consultant in the hospital’s hematology-oncology department National University cancer institute, Singapore.

“Cell therapy is one of the most promising and advanced treatments for chronic and life-threatening diseases such as cancer. SCG101, an individualized cancer treatment that is manufactured locally at the Cell Therapy Facility of the Science Authority of Singapore Health (HSA-CTF), offers potential new hope for these cancer patients Singapore,” mentioned Doctor Toh Han Chongsenior researcher at the National Cancer Center in Singapore.

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

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

T cells are important white blood cells in 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 cells infected with diseased pathogens or tumor cells.

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

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

About SCG Cell Therapy

SCG is a leading biotechnology company focused on the development of novel immunotherapies against infections and related cancers. The company targets the most common carcinogenic infections: Helicobacter pylori, human papillomavirus and hepatitis B, and develops a broad and unique portfolio of T cell therapies, antibodies and therapeutic vaccines against infections and to prevent and cure associated cancers. Established and based in SingaporeSCG combines regional strengths in Singapore, China and Germany, covering the entire value chain from research and discovery of innovative drugs, manufacturing, clinical development and commercialization. SCG collaborates with leading scientists and researchers to bring best-in-class, best-in-class medical products/technology to enhance innovation in medical product development.

For more information about SCG, visit www.scgcell.com.

About National Cancer Center Singapore

The National Cancer Center Singapore (NCCS) offers a holistic and multidisciplinary approach to cancer treatment and patient care. We treat almost 70% of oncology cases in the public sector and they benefit from the sub-specialization of our clinical oncologists. NCCS is also accredited by the US-based Joint Commission International for the quality of its patient care and safety. To provide some of the best cancer treatment and care, our clinicians work closely with our scientists who conduct robust cutting-edge clinical and translational research programs that are recognized internationally. NCCS strives to be a world leader in cancer center and shares its expertise and knowledge by offering training to local and foreign health professionals.

On National University cancer institute, Singapore

National University Cancer Institute, Singapore (NCIS) offers a wide range of cancer care and management covering both pediatric and adult cancers, with expertise in prevention, screening, diagnosis, treatment, rehabilitation and palliative care . The strength of the Institute lies in the multidisciplinary approach adopted to develop a comprehensive and personalized plan for each cancer patient and their family. Our award-winning clinician-scientists and clinician-scientists conduct translational research and clinical trials, providing patients with access to evidence-based cancer diagnostics, technologies and therapies. For more information about NCIS, visit www.ncis.com.sg.

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