BioRay Pharma Congratulates Lion TCR on NMPA IND Approval for mRNA-Encoded TCR-T Therapy GZL-016 in HBV-Related Hepatocellular Carcinoma

Nov 14, 2024 08:35 CST Updated 08:35

Lion TCR

Developer of Novel Immunotherapies

On November 12, 2024, the new drug clinical trial application (IND) for "GZL-016 Injection" submitted by Guangzhou Laien Biological Medicine Co., Ltd. (hereinafter referred to as "Laien Bio") received tacit approval from the National Medical Products Administration.。GZL-016 Injection is an mRNA TCR-T cell therapy indicated for hepatitis B virus-related hepatocellular carcinoma. This approval also marks an important breakthrough in the application of TCR-T cell therapy in the field of solid tumor treatment.Porton Biologics Ltd. extends its warm congratulations!

GZL-016 Injection Encodes T-cell Receptors (TCR) via mRNA, Targeting Hepatitis B Virus Surface Antigen. Thus, the T cells modified ex vivo are endowed with the ability to specifically recognize and kill HBV-related hepatocellular carcinoma cells. This autologous T-cell therapy leverages the transient expression characteristics of mRNA, combined with a clinical treatment regimen involving multiple infusions, aiming to ensure patient safety while delivering promising efficacy. Prior to treatment, patients do not need to undergo lymphodepletion, further enhancing the safety and accessibility of the therapy. The approval of this IND further demonstrates the R&D and innovation capabilities of Guangzhou Laien Biological Medicine Co., Ltd.

Porton Biologics Ltd., as the CDMO partner of Guangzhou Laien Biological Medicine Co., Ltd., has closely collaborated with Laien Bio to provide pharmaceutical research-related services for this project, ensuring the highest quality and timely delivery. The close cooperation between the two teams has significantly accelerated the IND application process for GZL-016 injection.

The autologous T cell therapy product owned by Guangzhou Laien Biological Medicine Co., Ltd. is the world’s first (First-in-Class) TCR-T cell therapy product targeting the hepatitis B virus surface antigen for the treatment of hepatitis B-related hepatocellular carcinoma. This product has previously received the world's first 1b/2 phase IND clinical trial approval from the U.S. FDA and has been granted Fast Track designation by the FDA. Porton Biologics Ltd. wishes Guangzhou Laien Biological Medicine Co., Ltd. further new progress in the field of mRNA-encoded TCR-T therapy, benefiting more patients.

About Laien Bio

Lion TCR is a clinical-stage biotechnology company focused on the development and commercialization of TCR therapies. The company has proactively utilized mRNA to encode TCRs for use in clinical trials treating liver cancer, demonstrating good safety and significant efficacy. Through an AI-powered TCR discovery platform, the company is expanding targets and indications to provide innovative therapies for unresolved clinical issues. In addition, the company has established an off-the-shelf therapy product platform beyond autologous cell therapy, including in vivo TCR-T therapies delivered via mRNA-LNP.

About Porton Biologics Ltd.

Porton Biologics Ltd. was established in December 2018 and is located in the Suzhou Industrial Park. Relying on the listed company, Chongqing Porton Pharmaceutical Co., Ltd. (stock code: 300363), it has built CRO and CDMO platforms for plasmids, viral vectors, cell therapy, gene therapy, and nucleic acid therapeutics. It provides end-to-end services from research packaging, library construction, process development, analytical method development, cGMP production to formulation filling, covering different stages of drug development to help customers accelerate the drug research and market launch process.
Porton Biologics Ltd. focuses on gene and cell therapy. Building on the successful experience of Porton Corporation, it centers around top international professionals and adheres to the service principle of "Customer First." With the brand philosophy of "Compliance, Professionalism, Dedication, and Open Collaboration," it continues the robust IP protection, project management mechanisms, and comprehensive quality management system of its parent company. Leveraging the core team's successful track record in advancing gene and cell therapy products from clinical trials to market approval, it provides high-quality and efficient services to global clients, enabling life-saving drugs to benefit the public sooner.