Lion TCR's TCR-T Therapy LioCyx-M004 Receives FDA IND Approval for Chronic Hepatitis B, Marking Third FDA Endorsement
Lion TCR
Developer of Novel Immunotherapies
Recently, Lion TCR announced that its innovative mRNA-encoded TCR-T cell therapy product, LioCyx-M004, has been approved by the U.S. Food and Drug Administration (FDA) to initiate a Phase 1b/2 clinical trial (IND) for the treatment of chronic hepatitis B (CHB). This isThe World's First to Receive FDA ApprovalTCR-T Cell Therapy for Chronic Hepatitis B Treatment, Also the First HBV-Specific TCR-T Therapy to Receive FDA Fast Track Designation.
01 Breakthrough Therapy: Multiple Certifications Highlight Innovation Value, FDA Triple Approval Recognizes Innovative Strength
LioCyx-M004 is an autologous T-cell therapy that uses mRNA to encode and express TCR targeting the hepatitis B virus surface antigen, granting T cells the ability to specifically recognize and kill HBV-infected hepatocytes. This innovative approach leverages the transient expression characteristic of mRNA in combination with multiple infusions, ensuring both optimal safety control and therapeutic efficacy.
This therapy has previously received FDA approval for the treatment of hepatitis B virus-related hepatocellular carcinoma, and now has also been approved to conduct clinical trials for chronic hepatitis B treatment, demonstrating the broad application prospects of this platform technology.Fast Track DesignationThis will accelerate the development and review process of the therapy, whileOrphan Drug DesignationThis brings new hope to patients with HBV-related hepatocellular carcinoma.
02 Global Hepatitis B Burden: Nearly 300 Million Patients in Urgent Need of a Cure, Innovative Therapies Bring New Hope
Hepatitis B Virus (HBV) infection is a major global health challenge, with approximately 296 million people worldwide living with chronic hepatitis B, including over 86 million patients in China, creating an urgent demand for effective treatment. Current antiviral drugs struggle to achieve functional cure (i.e., sustained clearance of hepatitis B surface antigen), with less than 10% of patients achieving effective control of the disease. LioCyx-M004, a TCR-T therapy developed by Guangzhou Laien Biological Medicine Co., Ltd., offers new hope for achieving functional cure for hundreds of millions of patients globally by precisely targeting HBV-infected cells and activating virus-specific T-cell immunity.
03 Clinical Data Astonishing: Low-Dose Group Shows HBsAg Reduction, Significant Safety Advantages
In the early Phase 1 clinical study, LioCyx-M004 has demonstrated good safety, significantly extending the survival period of patients with advanced liver cancer.Achieved a median overall survival of 33.1 months`, and observed a decrease in hepatitis B surface antigen (HBsAg),`Show anti-tumor and antiviral therapeutic effects。
Dr. Tingting Wang, Chief Medical Officer and Chief Operating Officer of Guangzhou Laien Biological Medicine Co., Ltd., stated: "We are conducting a dose-escalation study in hepatitis B patients and have already observed a decline in HBsAg in the low-dose group, which is very encouraging. Adoptive transfer and replenishment of patients' autologous HBV-specific TCR-T cells is a promising therapeutic approach that has the potential to rebuild the HBV-specific T-cell repertoire in patients. We are currently identifying the optimal treatment dose and regimen through this dose-escalation study."
It is worth noting that, before treatment, the patientNo need for clear infusion.(Clearing lymphocytes) further improved the safety and accessibility of the treatment for patients. In terms of safety, no cytokine storms or neurotoxic reactions were observed, indicating that the mRNA-encoded TCR-T therapy is a safe and effective treatment.
04 Strategic Upgrade: From Cancer Treatment to the New Battlefield of Antiviral Therapies
Dr. Peng Xiaoming, CEO of Guangzhou Laien Biological Medicine Co., Ltd., views this approval as a pivotal turning point for the company's development: "The approval to conduct clinical trials for chronic hepatitis B treatment marks a strategic expansion of our platform technology from the field of cancer treatment into the realm of viral infection treatment. As the clinical trials progress, we will accelerate the completion of the full value chain, from laboratory to clinic and then from clinic to market, providing innovative treatment options for hundreds of millions of hepatitis B patients worldwide while achieving dual returns of commercial and social value for the company."
05 Future Layout: in vivo TCR-T Therapy Receives Authoritative Validation, Industrial Transformation Accelerates
It is worth noting that,Guangzhou Laien Biological Medicine Co., Ltd.'s mRNA-encoded in vivo TCR-T targeting HBV has been validated by a prestigious U.S. cancer research institute.Studies have shown that this therapy exhibits a significant ability to kill HBV-positive cells in animal models, with therapeutic effects comparable to those of T cells engineered in vitro. This provides a solid scientific foundation for the in vivo TCR-T industry transformation targeting HBV.
The company is currently actively promoting this innovative direction and accelerating the development of in vivo TCR-T therapy. Compared with traditional ex vivo engineered T cell therapy, in vivo TCR-T therapy has the advantages of being "off-the-shelf," low cost, and high accessibility, which is expected to provide more patients with treatment opportunities.
The company is also upgrading its AI-empowered TCR target discovery platform, planning to expand its product pipeline to cover more solid tumor areas such as lung cancer, breast cancer, and gastrointestinal tumors.
About Laien Bio
Lion TCR is a clinical-stage biotechnology company incubated by the Agency for Science, Technology and Research (A*STAR) in Singapore. Its core product, a TCR-T cell therapy targeting hepatitis B virus (HBV), is the world's first to receive U.S. FDA approval for an international multicenter Phase II clinical trial for HBV-related diseases. It has obtained FDA Fast Track and Orphan Drug designations, as well as clinical trial approval from the National Medical Products Administration (NMPA) of China.
Leveraging an AI-driven TCR discovery platform and RNA technology, the company is actively expanding its product pipeline into various solid tumor and infectious disease fields. Guangzhou Laien Biological Medicine Co., Ltd. has developed a diversified product portfolio, including autologous cell therapy and allogeneic therapies, while focusing on the development of in vivo TCR-T therapy to significantly reduce treatment costs and enhance accessibility.
Highlights:
Major Breakthrough! Laien Bio's Liocyx-M004 Approved by FDA for International Multicenter Phase 2 Clinical Trial to Treat Liver Cancer
World's First! Laien Bio's mRNA-Encoded TCR-T Approved for Clinical Trials, Precisely Targeting Hepatocellular Carcinoma
LIONTCR
WeChat ID｜Laien Bio
Official Website｜https://www.liontcr.com/