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SCG Cell Therapy to Begin Trials of T-Cell Receptor Therapy for Liver Cancer Patients in Singapore

NEW YORK – SCG Cell Therapy said on Monday that Singapore's Health Sciences Authority (HAS) has cleared the firm's investigational new drug application for the firm's autologous T-cell receptor (TCR) therapy, SCG101, allowing the firm to begin evaluating the treatment in clinical trials for certain liver cancers.

Singapore-based SCG is evaluating the therapy for patients with hepatitis B virus (HBV)-associated hepatocellular carcinoma and has already received IND clearance from the National Medical Products Administration in China as well.

SCG101 involves engineering patients' T cells to express TCRs that recognize peptide fragments of pathogen-derived proteins — in this case, from HBV — on the surface of liver cancer cells. The treatment requires human leukocyte antigen (HLA) typing to ensure SCG101 can recognize both membrane and intracellular antigens.

According to SCG, the IND clearance in Singapore makes SCG101 the first cell therapy to receive multi-regional IND approval across Singapore and China.

"The multi-country IND approval … is a key milestone for SCG's cell therapy pipeline, proving our capability to fulfill regulatory requirements in the target markets," SCG CEO Frank Wang said in a statement. "This milestone pushes forward our mission to advance cell therapy to patients in need and strengthens our position as a key global player."

Last November, SCG partnered with the Cell Therapy Facility of Singapore's HSA to evaluate a manufacturing process for these types of therapies for HBV-related liver cancer. The process was validated in the good manufacturing practice (GMP)-certified facility.