LianBio Pioneers In Vivo TCR-T Therapy Leveraging mRNA Platform for HBV-Targeted Treatment

Sep 29, 2025 17:04 CST Updated 17:04

Lion TCR

Developer of Novel Immunotherapies

With the participation of major pharmaceutical companies, various in vivo CAR-T/NK/M projects have been initiated.In vivo is considered the most promising next-generation cell and gene therapy development strategy.

Now, Guangzhou Laien Biological Medicine Co., Ltd. is taking the lead in exploring the use of in vivo development strategies for TCR-T, standing at the forefront of international innovation.

in vivo TCR-T

Recently, a post released on the official WeChat account of Laien Bio disclosed:In vivo TCR-T is the future development direction of Guangzhou Laien Biological Medicine Co., Ltd.

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 scientific basis for the in vivo TCR-T industry transformation targeting HBV.

The company is currently actively promoting this innovative direction and accelerating the development process of in vivo TCR-T therapy.

May Support Rapid Clinical Translation

Another important reason why the editor is optimistic about Laien Biopharma's in vivo TCR-T clinical translation is the company's own expertise and experience in mRNA-encoded TCR-T.

Laien Bio is a company from Singapore.A*STAR-incubated clinical-stage biotech company, its main technology platform isTCR Discovery Platform and mRNA Technology Platform, combining these two platforms, utilizing mRNA for the transient expression of TCR in T cells to enhance its safety,A conservative dose-escalation design can be implemented in clinical trials, simultaneouslyAvailableSolid tumors and infectious diseases.

InTwo platformsOn the basis, Guangzhou Laien Biological Medicine Co., Ltd. has developed multiple TCR-T products.Product pipeline (including autologous or allogeneic), where the fastest progressing pipeline is an autologousTCR-T CellsLioCyx-M004, its two indications (Hepatitis B Virus-Related Hepatocellular Carcinoma and Chronic Hepatitis B) have all received approval from the U.S. FDA for their INDs, and in February this year, the FDA also approvedLioCyx-M004 Launches International Multi-Center Phase 2 Clinical TrialTreatment of Liver Cancer.

In the early Phase 1 clinical study, LioCyx-M004 demonstrated good safety, and the survival period of patients with advanced liver cancer was significantly prolonged.Median Overall Survival Reached33.1 months, with a decline in hepatitis B surface antigen (HBsAg) observed, demonstrating both anti-tumor and antiviral therapeutic effects.

Based on Laien Bio's research and development experience in autologous mRNA-encoded TCR-T cells and the early promise demonstrated by its leading projects, Laien Bio is poised to pave the way for future advancements in in vivo TCR-T development.

Summary

Different from the in vitro preparation of traditional cell therapy,The in vivo strategy has the advantages of being ready-to-use, low-cost, and highly accessible, which is expected to provide more patients with treatment opportunities. Meanwhile, in vivo cell therapy has also shown positive efficacy and safety in preclinical and early clinical stages. Based on the above, in vivo has becomeOne of the important development strategies for the next generation of cell and gene therapy.

Currently, global MNCs are placing their bets.In vivo cell therapy: In addition to AbbVie, AstraZeneca, and Gilead making high-profile acquisitions of in vivo cell development companies, other giants such as Novartis and Astellas have chosen to establish project collaborations.