Lion TCR's LioCyx-HBV Secures Historic FDA IND Clearance, Marking a New Era in Chronic Hepatitis B Treatment After Fast Track and Orphan Drug Success

Lion TCR, a leading clinical-stage T cell receptor (TCR) T cell therapy company, has announced a landmark achievement, securing Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for its cutting-edge therapy, LioCyx-HBV. This pivotal approval allows LioCyx-HBV to advance into clinical trials for chronic Hepatitis B (CHB), representing a beacon of hope for millions worldwide.

This latest milestone follows the earlier prestigious Fast Track Designation and Orphan Drug Designation, cementing LioCyx-HBV's status as a potentially revolutionary treatment.

The FDA's IND clearance is a critical regulatory green light, permitting Lion TCR to initiate Phase 1 clinical trials in the United States.

This marks a significant stride in evaluating the safety and efficacy of LioCyx-HBV, a specialized T cell therapy designed to target Hepatitis B virus (HBV) infected cells. For patients suffering from chronic Hepatitis B, a condition that afflicts over 300 million people globally and can lead to severe liver damage, cirrhosis, and liver cancer, the progression of LioCyx-HBV into human trials is truly transformative.

Adding to this monumental progress, LioCyx-HBV previously earned the FDA's Fast Track Designation.

This designation is awarded to therapies that address serious conditions and have the potential to fill an unmet medical need. Fast Track status is a game-changer, facilitating expedited development and review processes, meaning LioCyx-HBV could potentially reach patients sooner than traditional drug development timelines.

This underscores the FDA's recognition of the urgent need for more effective CHB treatments and the promising nature of Lion TCR's approach.

Furthermore, LioCyx-HBV was granted Orphan Drug Designation by the FDA. This status is given to drugs intended to treat rare diseases or conditions affecting fewer than 200,000 people in the U.S., or diseases affecting more than 200,000 but for which there is no reasonable expectation that the cost of developing and making available the drug will be recovered from sales in the U.S.

In the context of CHB, which can be considered 'orphan' in specific severe, treatment-resistant subsets, this designation provides various incentives, including tax credits for clinical research and market exclusivity upon approval, further incentivizing Lion TCR's continued innovation.

LioCyx-HBV is an autologous TCR-T cell therapy that harnesses the body's own immune system to combat chronic Hepatitis B.

The therapy involves engineering a patient's T cells to express T cell receptors that specifically recognize and eliminate HBV-infected liver cells. This highly targeted approach aims to achieve a functional cure for CHB, where the virus is suppressed to undetectable levels and HBsAg (Hepatitis B surface antigen) is cleared, offering a significant improvement over current treatments that often only suppress the virus.

Dr.

Woon-Kai Low, CEO of Lion TCR, expressed profound excitement regarding these achievements: "Securing IND clearance for LioCyx-HBV, hot on the heels of our Fast Track and Orphan Drug designations, marks an extraordinary triple milestone for Lion TCR. This is a testament to the dedication of our scientific team and the immense potential of our TCR-T cell therapy platform.

We are deeply committed to bringing this innovative, potentially curative treatment to chronic Hepatitis B patients who desperately need new therapeutic options."

These triple FDA designations—IND clearance, Fast Track, and Orphan Drug—collectively highlight the critical unmet medical need in chronic Hepatitis B and the FDA's confidence in LioCyx-HBV's potential to address it.

Lion TCR is now poised to embark on clinical trials, taking a momentous step towards transforming the landscape of CHB treatment and offering new hope for a functional cure to millions globally. This truly marks a new era in the fight against chronic Hepatitis B.