ILIAS Biologics announces the 2nd POC study, showing anti-inflammatory effects of ILB202 on preterm birth

ILIAS Biologics, Inc. announced that its latest research in collaboration with researchers at The University of Texas Medical Brand at Galveston (UTMB) is published in the journal Science Advances. The study showed successful results in preventing preterm birth and improving the fetus viability with ILB-202, ILIAS's anti-inflammatory exosomes developed through its EXPLOR® platform technology.

This study result is the second proof of concept that suggests significant anti-inflammatory effects of the same exosome (ILB202) from ILIAS Biologics, Inc. In April 2020, the researchers at the Korea Advanced Institute of Science and Technology (KAIST) and the ILIAS team published the same exosome's substantial efficacy in the septic mouse model in Science Advances. With this second POC study showing anti-inflammatory effects on premature birth, ILIAS Biologics, Inc. proved its pipeline's expandability using EXPLOR®.

Preterm birth is the leading cause of infant deaths, and rates are increasing over the past few decades. Infection and inflammation in the uterus are known to cause preterm birth and affect fetal mortality. Several studies are set out to explore new drugs inhibiting the inflammatory transcription factor NF-κB. Very few of these studies have progressed to clinical trials, and none are clinically in use.

Using an innovative technology called EXPLOR®, Exosomes engineering for Protein Loading via Optically Reversible protein-protein interaction, researchers in this study have injected the engineered exosomes that contain an inhibitor of NF-κB, super-repressor IκB(ILB202) into the maternal side. These engineered exosomes carrying an anti-inflammatory drug can cross the placental barrier through the mouse model's maternal bloodstream and reach the fetus, which is an innovative approach to effectively deliver the medicine to the fetus and prevent the preterm birth. This study has suggested novel therapeutics for delaying preterm birth and increasing the survival rate of the fetus via regulation of inflammatory cytokine expression and activation of inflammatory cells in maternal and fetal tissues by ILB202 exosome delivery.

"Exosomes are natural nanoparticles or vesicles in our bodies, and we have trillions of them circulating through us at all times. By packaging the medicine inside a bioengineered exosome and injecting it into the mother intravenously, the exosomes travel through the blood system, cross the placental barrier and arrive in the fetus, where they deliver the medicine," explains Dr. Ramkumar Menon, the corresponding author of the study and a professor in UTMB's Department of Obstetrics and Gynecology and Cell Biology.

"The study result suggests the possibility of the safe and effective treatment to prevent preterm birth by solving the problem of current medications - that cannot cross the placental barrier - with EXPLOR® technology and proves the enormous expandability of exosome-based treatment," said Chulhee Choi, CEO at ILIAS Biologics, Inc.

ILIAS is investing the proceeds of successful series B funding in 2020 to advance its platform technology and manufacturing capability, backed up by its strong R&D capability and intellectual properties. The company is also in active discussion with multiple global pharmaceutical companies for R&D collaboration and potential licensing out of its lead pipelines. Its successful POC study results have been published by international journals, and EXPLOR® technology has been granted the patent in the United States last July. Recently, ILIAS selected initial public offering (IPO) organizers and completed pre-audit aiming IPO in 2022.

Preterm Birth

Preterm birth is when a baby is born too early, before 37 weeks of pregnancy have been completed. In 2019, preterm birth affected 1 of every 10 infants born[i]. According to World Health Organization, an estimated 15 million babies are born preterm, and 1 million among them die every year. It is estimated that 80% of death and half of neurological complications in infants are caused by preterm birth.  

There are no medications to delay preterm birth and intervene in premature labor but only temporary measures to stop labor to improve a premature baby's prognosis. The global market size of medication to prevent and manage preterm birth is estimated at $1.1 billion (US dollar) in 2019, and it is estimated to grow to $2.8 billion in 2029. In the United States, it takes $20,000 to $100,000 for treatment/management of a premature baby, and total annual spending in the United States amounts to $26.5 billion[ii].

Exosomes

Exosomes are a type of extracellular vesicles, sized from 50nm to 200nm, released by cells in the body. Exosomes act as intercellular messengers delivering a variety of materials including RNA, Proteins, etc. Due to this unique function as a messenger between cells, exosomes are 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. was established in 2015 in South Korea to develop exosome-based therapeutics. Its platform technology, EXPLOR®, makes it possible to load large therapeutic molecules into exosomes. ILIAS Biologics, Inc. is actively developing various therapeutic exosomes, Exo-Targets®, as potential treatments for sepsis, pre-term birth, and various hard-to-treat diseases in inflammatory, metabolic areas, and oncology. 

ABOUT EXPLOR® technology

EXPLOR® technology is a novel protein-loading method that enables the active loading of large therapeutic cargo proteins 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's technology provides a unique solution to overcome this challenge and is expected to provide solutions for treating various diseases with significant medical unmet needs. The technology has been first published by Nature communication in 2016, and ILIAS has provided its first POC study result in sepsis in Science Advance in Apr. 2020. EXPLOR® technology has been granted the patent in the United States (July 2020) and in South Korea (May 2017). IILAS has applied for the patents in 7 other countries including Japan, China, India and Europe. 

[i] (Ref. WHO, GLOBAL PRETERM BIRTH ESTIMATES, http://ptb.srhr.org) & (Ref. WHO, Born too soon: the global action report on preterm birth, 2012, WHO | Born too soon)

[ii] (Ref. Future Market Insights, 2020)