Cold tumors refer to tumors that, for various reasons, are not recognized or do not elicit a strong response from the immune system, resulting in very few or no immune cells in the tumor microenvironment. Immunotherapy is ineffective against these types of tumors. Intratumoral injection of mRNA encoding cytokines can produce cytokines in situ within the tumor to alter the tumor microenvironment, converting the tumor from "cold" to "hot," thereby activating tumor-specific immune cells to ultimately kill and clear cancer cells. Multi-cytokine mRNA drugs for tumors can be used in combination with immunotherapy drugs and have shown significant clinical progress.
We offer a full-value chain solution with independent intellectual property rights, covering from cytokine combination screening to clinical sample production and regulatory submissions. Customers can choose from the following integrated or single module/technical point solutions based on their needs:
Multi cytokines combination screening
Multi-cistronic mRNA sequence design and synthesis
Tumor-specific capping analogs
LNP delivery systems suitable for local administration and non-LNP delivery systems
Enhanced UTR and Poly A tails
With these proprietary technologies, key raw materials, and R&D production equipment supply chains, InnoBio not only solves the challenges of mRNA cytokine stability and comprehensive product cost but also meets the development and full-chain autonomous control needs of customers for multi cytokine mRNA drugs.
Development process:
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Target Screening and Drug Design |
cytokines combination screening Homologous Gene Sequences design mRNA Sequences optimization for high expression and stability mRNA CDS optimization high expression and stable UTR Elements design |
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mRNA Design, Optimization, and Synthesis |
Tumor-Specific mRNA Capping Analogs Enhanced Expression and Stability Poly A Tails Multi-cistronic mRNA Sequences (up to 9 genes) Design and Synthesis Full-length, Full Modification mRNA Synthesis |
| LNP delivery and formulation development |
Tumor-Targeted LNP Delivery Systems Development of Non-LNP Delivery Systems Optimization of LNP Formulations for Specific Targets mRNA-LNP In Vitro Transcription Technology |
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Pharmacological and Safety Pre-evaluation |
In Vitro Efficacy Evaluation Animal Model Construction Immunogenicity Evaluation Pharmacokinetics and Pharmacodynamics Preliminary Safety Evaluation |
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Process Development and GMP manufacture |
Development of Stable plasmid engineering bacteria Plasmid Tertiary Library Construction, Process Development, and GMP Production mRNA Raw Material Process Development and GMP manufacture Lyophilized Formulation Process Development and GMP manufacture Quality Method Development and Research GMP-like Production and Supply of Raw Materials and Excipients GMP-like mRNA-LNP Matching Process Development |
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Safety Evaluation and Regulatory Submission |
Toxicity Evaluation Pharmacokinetics Body Distribution Regulatory Registration Services IND Application Support |