Lion TCR, a clinical-stage biotechnology company that originated from the Agency for Science, Technology and Research (A*STAR) in Singapore, has achieved a significant milestone with the US Food and Drug Administration (FDA) granting Investigational New Drug (IND) clearance for its TCR-T cell therapy, LioCyx-M004. This clearance allows the initiation of phase 1b/2 clinical trials for chronic hepatitis B (CHB), following earlier Fast Track and Orphan Drug designations for hepatitis B virus-related hepatocellular carcinoma (HBV-HCC).
The IND clearance is a pivotal step for Lion TCR, as it marks the first TCRT therapy to enter clinical development for CHB, a condition affecting over 290 million people globally. CEO Xiaoming Peng highlighted the transformative potential of LioCyx-M004, stating, “This triple recognition from the FDA underscores the transformative potential of LioCyx-M004 and validates our strategic approach targeting HBV-associated diseases through TCRT cell therapy.”
LioCyx-M004 is an innovative autologous cell therapy, engineered using mRNA to encode T-cell receptors that specifically target hepatitis B virus antigens. Preclinical studies have shown its ability to reduce viral antigen load and promote T-cell-mediated clearance of infected cells, maintaining a favourable safety profile. Chief Medical Officer Tina Wang noted, “Our ability to successfully redirect our lead candidate from oncology to virology demonstrates the remarkable versatility and broad therapeutic potential of our platform.”
Lion TCR’s approach offers advantages over traditional ex vivo T cell therapies, including shorter production cycles and reduced costs, potentially expanding treatment accessibility. The company is also enhancing its AI-powered TCR discovery platform to address additional solid tumour indications, such as lung, breast, and gastrointestinal cancers.
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