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

(Seoul, April 7, 2022) 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.

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