ILIAS Biologics will submit an IND application to Australian authorities in February this year for the world’s first Phase 1 clinical trial of its exosome-based anti-inflammatory drug candidate (ILB-202), said the company’s Co-CEO Choi Chulhee.

After the Phase 1 trial, a Phase 2 clinical trial will follow in the United States at the end of this year or early next year.

“This year will be the first year of the most important exosome clinical research in our company’s history. Like the world’s leading exosome engineering company along with Britain’s Evox Therapeutics and U.S. Codiak Biosciences, we will demonstrate the efficacy of exosome therapeutics and discuss potential investments by big pharmaceutical companies,” Choi said during a recent interview with Maeil Business Newspaper.

Exosomes are extracellular vesicles with a diameter of 50 to 200 nanometers in the human body. They were thought to be byproducts of cell metabolism, but nowadays they draw attention from the pharmaceutical industry as potential therapeutics as they can play a role in cell-to-cell communication.

Exosomes are likened to messengers or couriers as therapeutics can be loaded into them for precise delivery to target areas without causing side effects to other parts of the body.

Exosomes may serve as potential diagnostic biomarkers for disease or therapeutic compounds as they carry proteins, nucleic acids, lipids, and metabolites. However, potential therapeutics are still in the early stages of development.

ILIAS Biologics has the most advanced fourth stage of exosome engineering. Unlike previous generations, the fourth-generation exosome technology enables active loading of large therapeutic cargo proteins into the lumen of exosomes and delivery of payload proteins into a desired site in the cytoplasm, Choi explained.

In recognition of its breakthrough technology, the company received the ‘Cytiva Korea CEO Award` in 2019.

“There is no commercially available treatment in the exosome market yet, but as was the case with Moderna with mRNA platform technology, we will see an exosome engineering company whose corporate value could reach $100-200 billion within 10 years,” said Ham Taejin, Co-CEO of ILIAS Biologics.

By Kim Si-gyun and Minu Kim

[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]