ILIAS Biologics Inc. Receives HREC Approval to Initiate First-in-Human Clinical Trial Evaluating Exosome Therapeutics ILB-202, the Treatment for CSA-AKI

SEOUL, South Korea, April 7, 2022 /PRNewswire/ -- ILIAS Biologics Inc., a biotech company dedicated to developing a new treatment modality, engineered exosome therapeutics, announced today that it has received approval by the Human Research Ethics Committee (HREC) in Australia to initiate a Phase 1, the first-in-human trial of ILB-202, exosome therapeutics for the treatment of cardiac surgery-associated acute kidney injury (AKI).

ILIAS is the first Korean company to enter a global clinical trial for exosome-based therapeutics. The study will evaluate the safety and tolerability of ILB-202 in healthy adult volunteers.

ILB-202, containing the anti-inflammatory protein super-repressor lκB (srlκB), can attenuate inflammatory responses in various disease models through the introduction of srlκB, the dominant active form of lκBα, by inhibiting the translocation of NF-κB into the nucleus. ILIAS has developed ILB-202 using ILIAS' platform technology, EXPLOR^® (Exosomes engineering for Protein Loading via Optically Reversible protein-protein interaction). 

"With the approval to initiate the first-in-human clinical trial of ILB 202, we are one step closer to developing novel exosome-based therapeutics to help patients in need. ILIAS has proven the efficacy of ILB-202 in multiple inflammation-related therapeutic areas via proof-of-concept studies" said Chulhee Choi, MD, Ph.D., co-CEO of ILIAS Biologics Inc. "Starting with AKI, we plan to expand the indications of ILB-202 and look forward to providing millions of patients suffering from inflammatory diseases with an effective new treatment."

ILIAS demonstrated the therapeutic efficacy of their anti-inflammatory exosomes for the treatment of ischemia reperfusion injury-AKI (IRI-AKI). Systemic administration of anti-inflammatory exosomes into preclinical IRI-AKI mouse models significantly lowered AKI-related biomarker levels in the blood, i.e., BUN (blood urea nitrogen), creatine, and NGAL (Neutrophil Gelatinase-associated Lipocalin). This research was published in Kidney International, the official journal of the International Society of Nephrology, in June 2021.

AKI affects more than thirteen million people annually worldwide. A rapid decline in kidney function characterizes the disease, and multiple conditions such as acute tubular necrosis and interstitial nephritis can cause AKI. Severe AKI may result in permanent damage or even kidney dysfunction.

There is no approved drug with a clear therapeutic effect for AKI, rendering AKI therapeutics a field of high unmet need to substitute the current renal replacement therapy.

About Acute Kidney Injury (AKI):

Acute Kidney Injury (AKI) is defined as a rapid dysfunction in kidney function and structure, which results from secondary injury caused by multiple conditions such as acute tubular necrosis, glomerulonephritis, vasculitis, ischemia, and drug-induced nephrotoxicity. The pathological outcome of AKI varies widely from minor alteration of kidney function biomarkers to devastating loss of kidney function, which requires renal replacement therapy (RRT) ^[i].

Approximately thirteen million people are newly diagnosed with AKI worldwide every year, accompanying permanent loss in renal function. In the U.S, a relatively high incidence rate of 10,100 per 1 million people is reported. AKI is also showing a rapid increase in occurrence, as newly diagnosed patients in 2011 are 5-folds more than in 2001^[ii]. Nearly one-third of people who have undergone heart surgery suffer from AKI^[iii]. The rapid increase of incidence is influenced by 1) increased incidence of diabetes, heart failure, and sepsis due to the aging population, 2) increased usage of nephrotoxic contrast agents during operations such as cardiac catheterization, CT scan, and angiography, and 3) increased usage of antibiotics and NSAIDs, thus showing a more rapid increase of incidence in developed countries with high quality of medical infrastructures. The global market size of AKI therapeutics in 2018 is $1,527M, and the estimated compound annual growth rate (CAGR) is 8.1%^[iv]. 

ILB-202:

ILIAS's lead pipeline, ILB-202, is an exosome-based therapeutics containing the anti-inflammatory protein super-repressor lκB (srlκB). It is being developed for therapeutic use in inflammatory diseases, including acute and chronic ones. SrlκB, the dominant active form of lκBα, can attenuate inflammatory responses in various disease models by inhibiting the translocation of NF-κB into the nucleus. Conventional treatments targeted only upstream signaling pathways, while ILB-202 lowers the chance of off-target effects by directly targeting cytosolic core inflammation signals.

Exosomes: 

Exosomes are a type of extracellular vesicles, sized from 50 to 200nm, released by cells in the body. Exosomes act as intercellular messengers delivering various materials, including nucleic acids, proteins, etc. Due to this unique function as a messenger between cells, exosomes can be developed as treatments and a novel drug delivery system to carry drugs into the target cells in various diseases with significant unmet medical needs.  

ABOUT ILIAS Biologics Inc.:

ILIAS Biologics, Inc. is a biotech company dedicated to developing a new treatment modality, engineered exosome therapeutics. ILIAS has successfully created three proprietary platform technologies, EXPLOR^®, Exo-Target^®, and Pure-Exo^®. EXPLOR^® makes it possible to load large therapeutic molecules into exosomes, which can subsequently target previously undruggable intracellular pathways. Exo-Target^® allows active targeting of its engineered exosomes to specific organs or cells. Pure-Exo^® enables the manufacturing of high-purity exosomes on a commercial scale.ILIAS accelerates innovation through two tracks; (a) in-house pipeline development in inflammation and CNS areas and (b) research collaboration with industry partners interested in leveraging ILIAS' unique platform technology.

For more information, visit http://www.iliasbio.com.

ABOUT EXPLOR® technology:

EXPLOR® technology is a novel protein-loading method that enables the active loading of large therapeutic cargo proteins as free forms into the lumen of exosomes, nanosized extracellular vesicles, through cellular biogenesis processes.

This process involves controllable and reversible detachment of cargo proteins from the membrane of exosomes once they load into exosomes, which increases the efficiency of delivery of payload proteins into the cytoplasm or nucleus of target cells. While exosomes have been actively studied as novel therapeutic vehicles for intracellular drug delivery, the controllable loading of therapeutic cargo proteins as free forms in the exosomal lumen has remained a technical hurdle.

ILIAS' technology provides a unique solution to overcome this challenge and is expected to treat various diseases with significant medical unmet needs. The technology was first published by Nature communication in 2016, and ILIAS has provided its first POC study result in sepsis in Science Advance in Apr. 2020. ILIAS secured the patent for EXPLOR® technology in the United States, Japan, China, and South Korea. In addition, ILIAS applied for the patents in 5 other countries, including India and Europe.

SOURCE ILIAS Biologics