Integrated Solution for mRNA Vaccines Against Infectious Diseases

Tumor vaccines induce or enhance the body's specific active immune response against tumor antigens, thereby controlling and killing tumor cells, clearing minimal residual lesions, and establishing persistent anti-tumor memory. It is one of the most advanced technological routes in the field of tumor therapy. Tumor mRNA therapeutic vaccines have adjuvant effects and can efficiently express multiple antigens simultaneously. They have the advantages of strong immunogenicity and high efficacy, as well as low production costs and short development cycles, meeting the needs of personalized customization. They have achieved numerous disruptive results in clinical research1.

We offer comprehensive, proprietary intellectual property solutions covering the entire value chain from tumor antigen screening and prediction to clinical sample production and regulatory submission. Clients can choose from integrated solutions or individual modules/technical points according to their specific needs, including tumor neoantigen prediction, design and synthesis of multi-cistronic mRNA (expression of multiple antigens), immunostimulatory cap analogs, targeted LNP delivery systems, and immunostimulatory UTR and poly A tails. Leveraging proprietary intellectual property technologies, critical raw materials, and research and development production equipment supply chains, EnoBio can not only address the stability and comprehensive cost challenges of mRNA vaccines but also meet various demands for the development of vaccines with full intellectual property control.

case study:

Application Characteristic Analysis Key Capability Elements for Characteristics
Universal tumor mRNA vaccine Multi-antigen, strong cellular immunity, Intellectual Property Needs Original antigen structure design and homologous protein sequence design
Spleen or lymph node-specific cap analogs and targeted LNP delivery systems
Design and synthesis of multi-cistronic mRNA sequences (expression of multiple antigens)
Fully proprietary intellectual property
Personalized tumor mRNA vaccine Multi-antigen, strong cellular immunity, requires prediction of new antigens, cost-controllable, Intellectual Property Needs Prediction of tumor neoantigens
Design and synthesis of multi-cistronic mRNA sequences (expression of multiple antigens)
Fully proprietary intellectual property
Target selection based on customer indications, utilizing high-throughput sequencing and AI design platforms for sequence design, target and sequence biological evaluation.

Cancer vaccines: past, present and future; a review article. . 2022 Discov Oncol ,16;13(1):31.

Development process:

Antigen discovery and drug design

Prediction of tumor neoantigens

Antigen structure design

Homologous protein sequence design

High-expression and high-stability mRNA design

mRNA sequence CDS optimization

Enhanced expression UTR elements*

mRNA optimization and synthesis

Spleen or lymph node-specific mRNA cap analogs*

Enhanced expression and stability with poly A tails*

Design and synthesis of multi-epitope mRNA sequences (encoding multiple antigens)

Fully proprietary mRNA synthesis without IP risk

LNP delivery and formulation development

Spleen or lymph node-targeted LNP delivery system*

LNP formulation DOE screening for target mRNA and indications

mRNA-LNP lyophilization technology*

Immunogenicity and safety pre-evaluation

Protein expression detection

Animal model construction

Immune evaluation

Drug efficacy assessment

Preliminary safety assessment

Process development and GMP-level production

High-genetic stability plasmid engineering bacteria*

Plasmid Tier III library construction, process development, and GMP production

mRNA bulk process development and GMP production

Lyophilized formulation process development and GMP production*

Quality method development and research

GMP-like raw material production and supply*

Industrial-scale mRNA-LNP encapsulation equipment*

Safety evaluation and regulatory submission

Toxicology evaluation

In vivo distribution characterization

Pharmacokinetic-pharmacodynamic evaluation

Pharmacology data writing

IND submission service

* Available proprietary intellectual property solutions

Case Study:

Newly arising antigens derived from tumor cell gene mutations are generally exclusive to tumor cells, making them ideal targets for developing tumor vaccines. The strategy for personalized vaccine development involves identifying specific new antigens expressed in patient tumor cells through methods like genetic sequencing. These new antigens activate immune cell proliferation, allowing activated immune cells to migrate to and attack the tumor. In a study involving 34 pancreatic ductal adenocarcinoma (PDAC) patients, 28 of whom had undergone surgery, researchers administered antibody therapy to 19 surgically treated patients, with 16 of them subsequently receiving personalized mRNA-based cancer vaccines (autogene cevumeran) specific to new antigens. This treatment, combined with PD-L1 antibody atezolizumab and chemotherapy, significantly delayed recurrence in PDAC patients undergoing surgery. The study demonstrated the anti-cancer potential of mRNA cancer vaccines. While the sample size in this study was limited, the early results undeniably indicate the robust immune activity of mRNA vaccines, offering promising new treatment options for various immunotherapy-resistant cancers such as pancreatic cancer1.

1.Personalized RNA neoantigen vaccines stimulate T cells in pancreatic cancer. , 2023 Jun;618(7963):144.