"33 Domestic Exosome Companies... Major Firms Aim for IND Approval in 2023-2024"

2022 Global Bio Conference
'Extracellular Vesicle-Based Advanced Biopharmaceuticals
Domestic Development Trends and Cases' Presentation

[Asia Economy Reporter Kim Young-won] It has been found that there are about 33 domestic exosome development companies. Among them, major developers are reportedly aiming for clinical trial application (IND) approval around 2023-2024.

Dr. Yoo Jae-kwang, Chief Research Officer at ILIAS Biologics, presented on the domestic development trends and cases of extracellular vesicle (exosome)-based advanced biopharmaceuticals at the 'Global Bio Conference 2022' held on the 7th. Exosomes are extracellular vesicles sized 50?200 nm, and when drugs are loaded into exosomes, they can be delivered into target cells, attracting attention as next-generation drug delivery systems (DDS).

According to a survey of member companies of the Exosome Industry Association (EVIA), launched in February this year, there are 33 domestic exosome-related companies (members of the association), with about 1,300 employees. The cumulative investment attracted amounts to approximately $200 million (about 270 billion KRW).

Two-thirds (22 companies) of all member companies are developing exosome-based therapeutics. Among exosome therapeutic developers, 40% (9 companies) utilize 'Naive exosomes,' which use cell lines produced from exosomes in their original characteristics. Eight companies (35%) use 'Engineered exosomes,' which artificially modify the characteristics of exosomes produced for specific therapeutic purposes.

It was identified that there are 53 domestic exosome-related pipelines. Most are in the preclinical stage of research and development, and ILIAS Biologics is the only company to have received IND approval in Australia for the Phase 1 clinical trial of 'ILB-202,' a treatment for acute kidney injury after cardiac surgery (CSA-AKI). Dr. Yoo stated, "Among the 53 pipelines, the largest number, 32, are developments using engineered exosomes due to the potential for indication expansion and efficacy enhancement."

By cell line producing exosomes, 29 cases use stem cells showing regenerative and anti-inflammatory effects, accounting for more than half; 17 cases use human cells derived from non-stem cells such as immune cells; and 7 cases use bacteria. Regarding indications, pipelines targeting autoimmune and inflammatory diseases are the most numerous at 17, followed by oncology and neurology fields.

Globally, as exosomes grow, collaborations with pharmaceutical companies continue. Dr. Yoo explained, "Since the global deal on exosome therapeutic development in 2017, global partnering has been centered around Codiak in the U.S. and Evox in the U.K. In 2020, a global deal worth about 12 trillion KRW was made."

Domestic exosome companies are also actively collaborating with domestic and international firms. In June, ILIAS Biologics signed a joint research agreement with JW Pharmaceutical to develop targeted exosome therapeutics loaded with small molecule anticancer drugs. Exosystem Tech signed an agreement with Daewoong Pharmaceutical in January to jointly develop stem cell-derived exosome therapeutics.

Dr. Yoo introduced major domestic exosome developers such as SNE Bio, Primoris, and Shift Bio, stating, "They are reportedly aiming for clinical IND approval in 2023-2024."

This content was produced with the assistance of AI translation services.