The platform's versatility is evident as it has transitioned from oncology to virology, aiming to develop treatments for various cancers and infectious diseases, including hepatitis B.

The FDA's triple milestone recognition highlights the therapy's potential and validates Lion TCR's strategy of targeting HBV-related diseases with TCR-T cell therapy.

LioCyx-M004 is an autologous cell therapy engineered with mRNA to encode T-cell receptors specific to hepatitis B virus antigens, showing promise in reducing viral load and clearing infected cells.

Validation from a major U.S. cancer research institute supports the efficacy of Lion TCR's in vivo TCR-T therapy, demonstrating significant effectiveness in animal models.

Lion TCR utilizes AI discovery and advanced RNA technology to develop both autologous and off-the-shelf TCR therapies, with plans to expand into other solid tumors like lung, breast, and gastrointestinal cancers.

Lion TCR has received FDA IND clearance to initiate phase 1b/2 clinical trials for its innovative TCR-T cell therapy, LioCyx-M004, targeting chronic hepatitis B (CHB), making it the first therapy of its kind to enter clinical development for this disease.

Developed by Lion TCR, originating from Singapore's A*STAR, this therapy is the first HBV-specific TCR-T treatment to gain FDA approval for a Phase II trial internationally, targeting a global patient population of over 290 million.

The company's in vivo TCR-T platform offers advantages such as shorter production times, lower costs, and broader accessibility compared to traditional ex vivo T cell therapies, potentially transforming treatment approaches.

The therapy aims to treat over 290 million people globally with CHB and has shown promising antiviral activity and safety in early studies.

Preclinical and early clinical data indicate LioCyx-M004 can lower viral antigens with a favorable safety profile, supported by validation from a U.S. cancer research institute.

This FDA approval marks the third major regulatory milestone for LioCyx-M004, following Fast Track and Orphan Drug Designations for HBV-related hepatocellular carcinoma.