Lion TCR Announces FDA Fast Track Designation for HBV-Specific TCR-T Therapy LioCyx-M004 in Hepatocellular Carcinoma

Singapore、GUANGZHOU, China and LOS ANGELES, U.S., Dec. 23, 2021 /PRNewswire/ -- Laien Biologics today announced that its lead product, LioCyx-M004, has been granted Fast Track designation by the U.S. FDA. This is the world's first TCR-T cell therapy utilizing mRNA electroporation technology to target the hepatitis B surface antigen for the treatment of hepatitis B virus-related hepatocellular carcinoma (HCC). The Fast Track designation will provide an expedited regulatory pathway for Laien Biologics' first-in-class product, LioCyx-M004, and also signifies that the efficacy demonstrated in earlier clinical trials, particularly the improvement in patient survival, has been recognized by the FDA.

The FDA's Fast Track program aims to allow companies to discuss drug development plans with the FDA through early and in-depth communication, enabling drugs that address serious and potentially life-threatening medical conditions, as well as those that fill unmet clinical needs, to undergo expedited review for approval. This allows innovative drugs with good efficacy to benefit patients earlier.

LioCyx-M004 has demonstrated good safety and a significant improvement in patient survival in an early Phase 1 study. In September this year, the product received FDA IND approval to conduct a Phase 1b/2 international multicenter clinical trial. This will be the world's first clinical study using HBV-specific TCR-T cell therapy to treat hepatitis B-related hepatocellular carcinoma.

"Hepatitis B-related hepatocellular carcinoma sees an annual addition of up to 420,000 new patients, with the majority of advanced hepatocellular carcinoma patients experiencing recurrence shortly after treatment. The current treatment options have very limited efficacy in extending patient survival. We believe that our innovative TCR-T cell therapy can address this urgent and significant unmet clinical need. Following the Fast Track designation, we look forward to closer communication with regulatory agencies to expedite the drug approval process for our product to be available for patient use. We are currently preparing for patient enrollment in our Phase 1b/2 clinical trials in the United States and Asia," said Dr. Tingting Wang, Chief Operating Officer and Chief Medical Officer of Guangzhou Laien Biological Medicine Co., Ltd.

"The T-cell therapy field is vibrant and highly competitive. With expedited programs like Fast Track, the pace of innovative therapy releases is faster than ever before. Our Fast Track designation, along with the previously granted Orphan Drug designation, can drive regulatory authorities to accelerate the approval of our world-first TCR-T cell therapy targeting hepatitis B virus antigens," said Dr. Peng Xiaoming, CEO of Guangzhou Laien Biological Medicine Co., Ltd.

References:

1. U.S. Food and Drug Administration (FDA). Fast Track. Available from: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track/

2.  https://finance.yahoo.com/news/lion-tcr-announces-fda-ind-072300134.html