Abogen Biosciences

Abogen Biosciences is a biopharmaceutical company centered around mRNA technology. While it focuses on developing vaccines and therapeutics through its internal research and development, it also offers external research support functions, as evidenced by its listing on CRO lists in the non-clinical domain. Here, we will introduce the characteristics of Abogen Biosciences and an example of a disease model.

Features of Abogen Biosciences' Non-clinical Testing Contract Services

Integrated platform for consistent support of mRNA drug discovery

Abogen Biosciences is,Owns a proprietary platform covering mRNA drug design, preclinical development, and manufacturingWe are doing this. Unlike typical CROs that are divided by testing stages, our feature is that we can provide integrated mRNA sequence design, formulation development, and evaluation systems. This allows for rapid reflection of validation results from the preclinical stage to the next stage, contributing to improved speed and reproducibility of the overall development. We can provide seamless support from the early stages of drug discovery with clinical transition in mind.

Non-clinical evaluation capabilities specialized in LNP technology and mRNA

with proprietary LNP (lipid nanoparticle) delivery technology as its strengthHigh expertise in non-clinical evaluation addressing unique challenges of mRNA therapeuticsWe have expertise. Specifically, we can handle verification items that differ from conventional small molecule and antibody drugs, such as in vivo distribution and expression characteristics of mRNA, stability of LNPs, and evaluation of immune response and toxicity. Our accumulated knowledge specialized in mRNA allows us to precisely understand the characteristics of candidate compounds, contributing to reduced development risk and increased success rate.

GMP manufacturing base and global regulatory compliance capabilities

We have a large-scale manufacturing facility that complies with GMP standards and a CDMO function that can handle everything from research stages to manufacturing scale. We also have extensive experience in dealing with regulatory authorities in various countries.Achievements such as obtaining Emergency Use Authorization (EUA) in Indonesia and conducting a large-scale international Phase III clinical trial with 30,000 participants.We have established a support system that can design and consult on data with approval applications in mind from the non-clinical stage, which is useful for companies aiming for global development.

An example of a disease model held by Abogen Biosciences

KRAS mutated tumor model

KRAS-mutated tumor models are used to reproduce the frequent KRAS gene mutations in refractory cancers and to evaluate the efficacy of mRNA vaccines and immunotherapies. They are characterized by their ability to analyze tumor growth suppression and immune response induction from multiple angles, and are particularly useful forPreclinical validation of personalized cancer vaccinesIt is suitable. Highly accurate evaluations are possible by considering interactions with the immune system.

Disease-specific mouse model

We conduct non-clinical evaluations utilizing disease-specific mouse models in the fields of infectious diseases and tumors. In the infectious disease field, we use models that can verify immune responses against mutant strains to evaluate the protective efficacy of vaccines and the induction of neutralizing antibodies. In the tumor field, including KRAS mutant models,Systematically verify the mechanism of action and efficacy of cancer immunotherapy.And analysis is being conducted based on the characteristics of mRNA therapeutics.

Abogen Biosciences Non-clinical Trial Cases

Efficacy Study Using a KRAS-Mutated Tumor Model

In preclinical studies using a KRAS-mutated tumor model, we verified the efficacy of our proprietary KRAS mRNA vaccine "ABO2102." Administration to a mouse model showedTumor shrinkage was confirmed with monotherapy.Furthermore, in combination with PD-1 antibodies, potent anti-tumor effects, including tumor eradication, have been reported. Data also showed activation of the immune response, such as increased T cell infiltration into the tumor. These are preclinical cases demonstrating the potential of mRNA vaccines for cancer immunotherapy.

Abogen Biosciences Corporate Information