First mRNA CAR-T Therapy Targeting Two Autoimmune Diseases Advances to Phase 3: Can the 'mRNA + Cell Therapy' Combination Reignite the Field?

Jan 12, 2024 07:24 CST Updated 07:24

Cartesian Therapeutics

Pharmaceutical R&D Developer

Selecta Biosciences

First-Generation Nanoparticle Immune Modulation Drug Developer

The potential of mRNA therapy extends far beyond COVID-19 vaccines. After the COVID-19 boon fades, many companies are exploring more possibilities of mRNA technology. The path from mRNA COVID-19 vaccines to infectious disease vaccines is relatively easier to achieve and is also the direction where giants like Moderna and BioNTech have taken the lead. Using mRNA for cancer vaccines, genetic disease treatments, protein replacement therapies, etc., are all relatively conventional expansion areas, and numerous companies are already making their moves.

As mRNA technology urgently needs to expand its boundaries, cell therapy, which already has products on the market, is also seeking better solutions, thusR&DThe combination of the two has sparked a wave of "mRNA + cell therapy" innovation.

Descartes-08, developed by Cartesian Therapeutics, is the first mRNA-based CAR-T therapy., its Phase 1b/2a clinical study for the treatment of myasthenia gravisShowed good safety and therapeutic potential in China. Cartesian Therapeutics and Selecta Biosciences have merged and gone public to advance the Phase 3 study of this candidate product, with a Phase 2 study for systemic lupus erythematosus soon to be initiated.Myeloid's MT-101: CD5-Targeting CAR Monocyte (CAR-M) Therapy Utilizing mRNA TechnologyAlready in the treatment of relapsed/refractory peripheral T-cell lymphoma (PTCL) patients1/2 Phase Clinical TrialThe first patient was dosed in the trial.

CUREMED's Zuo Chijian team, in collaboration with Zhang Yan and Song Xianmin's research team from the First People's Hospital of Shanghai Jiao Tong University School of Medicine/Shanghai First People's Hospital, published an article in Molecular Therapy,First Report of Using Circular mRNA (cmRNA) to Prepare TCR-T Cell Therapy for Treating Human Cytomegalovirus (CMV) Infection After Hematopoietic Stem Cell Transplantation, on days 7 and 11 post-electroporation, approximately 80% and 50% of T cells express exogenous TCR receptors.CUREMED hasBuilt an mRNA technology platform, applied mRNA-encoded TCR, and introduced it into T cells. The transient expression characteristics of mRNA make TCR-T therapy safe and controllable.

In addition, there are examples of using mRNA technology to directly generate CAR-T therapy and editing hematopoietic stem cells in vivo. The combination of "mRNA + cell therapy" can leverage the strengths of each technology, enhance safety, reduce production costs, and accelerate R&D iteration. However, this field still faces many challenges: How to improve the transfection efficiency of mRNA? What are the optimization approaches to enhance mRNA stability? How to precisely target T cells for in vivo modification? What inspiration can cutting-edge international research offer to companies in China to help them avoid potential pitfalls?22024 International Biopharmaceutical Innovation Conference held on June 14-15, 2024Invitation to the 3rd Nucleic Acid Drug Development Forum, and jointly explore technical challenges and implementation paths. Only by pooling ideas can we achieve long-term success.

The 3rd Nucleic Acid Drug Development Forum

In Vivo Self-Assembling Drug Delivery Technology Empowers RNAi Therapy Development
Applications of Self-replicating mRNA in Cancer and Rare Diseases
Novel Lipid Nanoparticle mRNA Delivery System
Artificial Intelligence-Driven Personalized Immunotherapy for Tumors
Current Status and Commercial Production Needs of the mRNA Drug Industry
New Advances in Innovative mRNA Tumor Vaccines for HPV-Positive Head and Neck Cancer
Progress in mRNA Infectious Disease Drug Development
Development and Application of Circular RNA
Research Progress in the Development of siRNA Dual-Target Drug Design
Research Limitations and Trends in the Development of siRNA for Hepatitis B Treatment
Modification of ASO and Application of Self-Delivery Technology
Delivery and CMC Strategies for GalNAc-Conjugated Small Nucleic Acids
Advantages and Challenges of Engineered tRNA
Process Development and Scale-Up of Small Nucleic Acid Drugs
saRNA Therapy and Delivery Technology for Small Nucleic Acid Drugs

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