Technology

テクノロジー

We develop next-generation therapeutics using the unique biological functions of extracellular vesicles (EVs), aiming for long-lasting and clinically meaningful treatments in respiratory medicine.

TOP

Based on the cell sources and manufacturing technology established with
EM-001, we are pioneering the future of EV-based therapies.

Core Asset

Human bronchial basal cell (HBBC) and EVs

Our proprietary Human Bronchial Basal Cells(HBBC) and their extracellular vesicles (EVs) possess the following unique characteristics:

HBBC-EVs exhibit desirable properties:

  • Low immunogenicity (low MHC-I, high HLA-G)
  • Anti-inflammatory profile (enriched miRNAs linked to inflammation resolution)
  • Efficient pulmonary delivery (strong lung tropism)
Core Asset diagram

Core technology 1

Manufacturing Technology(upstream-downstream)

The isolation and purification of extracellular vesicles (EVs) is still widely regarded as a major technical challenge in the industry. However, we have already overcome this hurdle by establishing a robust and scalable manufacturing process.

For our lead pipeline, EM-001, we have established a robust manufacturing process.

  • Ultra-High Purity: Achieved EV purity levels exceeding 99%.
  • Impurity Removal: Reduced host cell proteins and DNA to below detection limits.
  • Scalability: Established a clinical-grade, scalable manufacturing process.
  • Robustness: Confirmed consistent batch-to-batch reproducibility.

This integrated process enables the production of EV formulations with exceptionally high purity exceeding 99%.

Furthermore, we have completed formal consultations with the PMDA (Pharmaceuticals and Medical Devices Agency) regarding quality assurance through these manufacturing methods.

With regulatory alignment secured, we are well-positioned and steadily advancing toward clinical trials.

Manufacturing Technology diagram

Core technology 2

EV Engineering for functionalization

Targeted EV delivery is the next frontier in medicine. Although standard surface modification approaches have been tested, achieving optimal density for targeting ligands remains an industry-wide hurdle. We are implementing a proprietary design to overcome these limitations, significantly enhancing how functional molecules are presented on the EV surface.

Our approach focuses on the following key innovations:

  • Proprietary membrane engineering
    Designed to significantly improve the surface display efficiency of targeting elements on EV membranes.
  • Precision targeting development
    We have successfully expressed functional moieties targeting specific antigens highly prevalent in solid tumors.
  • Enhanced targeted delivery
    By combining our proprietary EV surface technology with antigen recognition, our platform enables efficient delivery of therapeutic payloads to disease-relevant tissues.

This strategy leverages both the natural delivery capability of EVs and precise molecular targeting, enabling a powerful next-generation therapeutic platform.

EV Engineering diagram