ILIAS Biologics is a biotech firm that focuses on creating therapeutic molecules. Their unique platform technology allows for the loading of large therapeutic molecules into exosomes. The company is currently working on developing various therapeutic exosomes that could potentially be used to treat sepsis, pre-term birth, and other difficult-to-treat diseases in the inflammatory and metabolic fields.

Tags

Digestive System Disorders

Other Diseases

Urogenital Diseases

Exosomes

Recombinant protein

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Nervous System Diseases	2
Immune System Diseases	2
Neoplasms	1

Top 5 Drug Type	Count

Exosomes	9
Recombinant protein	1

Top 5 Target	Count

NF-κB(Nuclear factor NF-kappa-B complex)	4
CARD9 x TRIM62	1

Drugs associated with ILIAS Biologics, Inc.

ILB-202

Target

NF-κB

Mechanism

NF-κB inhibitors

Active Org.

ILIAS Biologics, Inc.

Originator Org.

ILIAS Biologics, Inc.

Active Indication

Acute Kidney Injury [+1]

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

ILB-31X

Target-

Mechanism-

Active Org.

ILIAS Biologics, Inc.

[+1]

Originator Org.

ILIAS Biologics, Inc.

Active Indication

Fatty Liver, Alcoholic [+1]

Inactive Indication-

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

ILB-312

Target

NF-κB

Mechanism

NF-κB inhibitors

Active Org.

ILIAS Biologics, Inc.

Originator Org.

ILIAS Biologics, Inc.

Active Indication

Rheumatoid Arthritis

Inactive Indication-

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with ILIAS Biologics, Inc.

NCT05843799

/ CompletedPhase 1

A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of ILB-202 Administered Intravenously As Single Ascending Doses to Healthy Participants

This is a Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of ILB-202 Administered Intravenously as Single Ascending Doses to Healthy Participants. Male or female subjects aged 18 to 50 years (inclusive) who fulfill the inclusion/exclusion criteria will be enrolled in this study.

Start Date16 May 2023

Sponsor / Collaborator

ILIAS Biologics, Inc.

100 Clinical Results associated with ILIAS Biologics, Inc.

0 Patents (Medical) associated with ILIAS Biologics, Inc.

Literatures (Medical) associated with ILIAS Biologics, Inc.

04 Jul 2025·Science Advances

Single-cell analysis of the decidua unveils the mechanism of anti-inflammatory exosomes for chorioamnionitis in nonhuman primates

Article

Author: Shin, Seung Han ; Yoon, Seung-Bin ; Lee, Eun Mi ; Park, Cheolhyoung ; Choi, Chulhee ; Gee, Heon Yung ; Won, Jae Kyung ; Kim, Hye-Jung ; Park, Chan-Wook ; Kim, Ji-Su ; Choi, Hojun ; Jang, Seung Hyun

The effectiveness of exosomes engineered to carry a dominantly active variant of inhibitor α of nuclear factor κB (NF-κB) (IκBα), super-repressor IκB (srIκB), that inhibits the expression of NF-κB in various animal models of inflammatory diseases has been demonstrated. In this study, we used a lipopolysaccharide (LPS)–induced chorioamnionitis model in pregnant nonhuman primates to explore the therapeutic potential and mode of action of srIκB-loaded exosomes (Exo-srIκBs). Intraamniotic injection of LPS induced infiltration of BCL2A1-positive neutrophils and CD68-positive macrophages in the extraplacental membranes, causing fetal lung injury. Conversely, administration of Exo-srIκB via intraamniotic and intravenous routes (6.9 × 10 10 and 4 × 10 11 particle numbers, respectively) ameliorated these effects. Single-cell RNA sequencing of the decidua and bulk RNA sequencing of the choriodecidua highlighted that Exo-srIκB treatment mitigated LPS-induced inflammatory pathways, particularly in macrophages, leading to a cascade effect on neutrophils through NF-κB signaling inhibition. These findings underscore the potential of Exo-srIκB as a therapeutic strategy for chorioamnionitis.

15 Jul 2024·Stem Cells Translational Medicine

Exploring the clinical transition of engineered exosomes designed for intracellular delivery of therapeutic proteins

Review

Author: Sub, Yujin ; Gee, Heon Yung ; Jang, Deok-Jin ; Choi, Chulhee ; Kim, Hye-Jung ; Kim, Minseong ; Choi, Hojun

Abstract:

Extracellular vesicles, particularly exosomes, have emerged as promising drug delivery systems owing to their unique advantages, such as biocompatibility, immune tolerability, and target specificity. Various engineering strategies have been implemented to harness these innate qualities, with a focus on enhancing the pharmacokinetic and pharmacodynamic properties of exosomes via payload loading and surface engineering for active targeting. This concise review outlines the challenges in the development of exosomes as drug carriers and offers insights into strategies for their effective clinical translation. We also highlight preclinical studies that have successfully employed anti-inflammatory exosomes and suggest future directions for exosome therapeutics. These advancements underscore the potential for integrating exosome-based therapies into clinical practice, heralding promise for future medical interventions.

01 Nov 2023·BMB reports

Discovering the anti-cancer phytochemical rutin against breast cancer through the methodical platform based on traditional medicinal knowledge.

Author: Kim, Jae-Hoon ; Choi, Chulhee ; Sim, WooGwang ; Lee, Jungsul ; Jeon, Jongwook ; Lee, Jungwhoi

A number of therapeutic drugs have been developed from functional chemicals found in plants. Knowledge of plants used for medicinal purposes has historically been transmitted by word of mouth or through literature. The aim of the present study is to provide a systemic platform for the development of lead compounds against breast cancer based on a traditional medical text. To verify our systematic approach, integrating processes consisted of text mining of traditional medical texts, 3-D virtual docking screening, and in vitro and in vivo experimental validations were demonstrated. Our text analysis system identified rutin as a specific phytochemical traditionally used for cancer treatment. 3-D virtual screening predicted that rutin could block EGFR signaling. Thus, we validated significant anticancer effects of rutin against breast cancer cells through blockade of EGFR signaling pathway in vitro. We also demonstrated in vivo anti-cancer effects of rutin using the breast cancer recurrence in vivo models. In summary, our innovative approach might be proper for discovering new phytochemical lead compounds designing for blockade of malignant neoplasm including breast cancer. [BMB Reports 2023; 56(11): 594-599].

News (Medical) associated with ILIAS Biologics, Inc.

29 Sep 2025

·www.einpresswire.com

ILIAS Biologics Publishes Phase 1 Clinical Trial Results of ILB-202 in JEV

First-in-human study of a systemically administered anti-inflammatory engineered exosome therapy highlights its clinical potential and commercial viability SEOUL, EUNPYEONG, SOUTH KOREA, September 28, 2025 / EINPresswire.com / -- ILIAS Biologics Inc. (ILIAS, CEO: Dr. Chulhee Choi), a biotech company pioneering precision therapeutics based on engineered exosomes, announced that the results of its global Phase 1 clinical trial for its lead candidate, ILB-202, have been published in the September 2025 issue of the Journal of Extracellular Vesicles (JEV), the official journal of the International Society for Extracellular Vesicles (ISEV). JEV is a leading peer-reviewed journal indexed in the Science Citation Index (SCI), with an impact factor of 16. The publication of this study not only validates the scientific and medical relevance of ILB-202 but also underscores its global competitiveness and commercial potential in the rapidly growing field of exosome-based therapeutics. The article, titled “Safety and Anti-Inflammatory Effects of Engineered Extracellular Vesicles (ILB-202) for NF-κB Inhibition: A Double-Blind, Randomized, Placebo-Controlled Phase 1 Trial” presents comprehensive data on the safety, tolerability, and exploratory pharmacodynamic properties of ILB-202 when administered intravenously to healthy volunteers. The randomized, double-blind, placebo-controlled trial confirmed that ILB-202 was safe and well tolerated at all tested dose levels. Most notably, this study marks the world’s first clinical demonstration of a systemically administered engineered exosome that selectively modulates pathological inflammation without inducing broad immunosuppression—signaling a paradigm shift in the treatment of immune-related diseases. Through single-cell RNA sequencing of peripheral blood samples collected before and after drug administration, the study demonstrated that ILB-202 primarily targets subsets of monocytes and selectively downregulates NF-κB, a key driver of inflammatory signaling. Concurrently, it activates anti-inflammatory pathways, such as those involving TGF-β and visfatin, promoting a return to immune homeostasis. Unlike conventional NF-κB inhibitors, which frequently suppress normal immune function and pose safety concerns, ILB-202 preserves physiological immunity while precisely targeting pathologically overactivated inflammation. This differentiated mechanism underscores its potential as a next-generation immunomodulatory agent. This trial represents the first-in-human application of ILB-202, developed using ILIAS’s proprietary exosome engineering platform, EXPLOR ® . It is also the first trial globally to demonstrate both the safety and pharmacodynamic activity of a systemically administered engineered exosome. This milestone significantly broadens the industrial and clinical potential of exosome-based therapeutics—not only as standalone treatments but also as scalable platform drugs. Strategic applications are anticipated in high unmet-need areas such as autoimmune and rare inflammatory diseases. The trial was conducted in collaboration with Professor Heon Yung Gee of the Department of Pharmacology at Yonsei University College of Medicine. It was supported by the Ministry of Health and Welfare of Korea through the Korea Health Industry Development Institute (KHIDI), under the Advanced Biomedical Technology Development Program. Dr. Chulhee Choi, CEO of ILIAS, stated, “ILB-202 is a next-generation immunomodulatory exosome therapy with broad potential across systemic inflammatory diseases. This publication in JEV marks a pivotal milestone, validating the scientific rationale and clinical feasibility of our platform. We are committed to accelerating global development and expanding into additional indications through strategic collaborations and licensing partnerships.” Meanwhile, ILIAS is currently advancing protocol development and regulatory discussions to initiate the next phase of clinical trials for ILB-202. In parallel, the company is accelerating the industrialization and commercialization of next-generation exosome therapeutics by expanding its pipeline across multiple immunology and inflammatory disease indications using its proprietary exosome platform. ILIAS ILIAS Biologics Inc. dhong@iliasbio.com Visit us on social media: LinkedIn Facebook Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 1

18 Feb 2025

·www.iliasbio.com

ILIAS Biologics Publishes Collaborative Study on Exosome-based Therapeutics for Brain Neuroinflammation

ILIAS Biologics (CEO Dr. Chulhee Choi, hereinafter "ILIAS"), a biotech company specializing in exosome-based therapeutics, announced the results of a collaborative study conducted with Professor Youn-Hee Choi from the Department of Physiology at Ewha Womans University College of Medicine and Professor Heon Yung Gee from the Department of Pharmacology at Yonsei University College of Medicine. The study confirmed that exosomes loaded with an NF-κB (nuclear factor kappa B) inhibitory protein, termed as Exo-srIκB, effectively mitigate neuroinflammation associated with aging. Please check out the link below for more information. News Link

Clinical Result

04 Nov 2024

·www.prnewswire.com

Exosome Therapies on the Rise as 70+ Major Companies Driving Development in the Field | DelveInsight

Exosomes are emerging as key tools in personalized and regenerative medicine, offering precise, targeted therapy with low immune risk. Their potential spans cancer, chronic disease, and regenerative applications, driven by biopharma's investment in biologics and gene therapies. Stem cell-derived exosomes further enhance tissue repair and immune modulation, positioning exosomes as transformative in next-gen therapeutics. LAS VEGAS, Nov. 4, 2024 /PRNewswire/ -- DelveInsight's ' Exosomes Pipeline Insight 2024 ' report provides comprehensive global coverage of available, marketed, and pipeline exosomes-based therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the exosomes-based therapies pipeline domain. Key Takeaways from the Exosomes-based Therapies Pipeline Report DelveInsight's exosomes pipeline report depicts a robust space with 70+ active players working to develop 80+ pipeline therapies for various indications. Key exosomes-based therapies companies such as Capricor Therapeutics, Regeneus, Aegle Therapeutics, Innovex Therapeutics, Coya Therapeutics, EV Therapeutics, StemXO Therapeutics, Brexogen, ILIAS Biologics, Organicell Regenerative Medicine, Codiak BioSciences, Direct Biologics, Exostemtech, Brexogen, OmniSpirant, ShiftBio Inc., and others are evaluating new exosomes-based therapies to improve the treatment landscape. Promising exosomes-based therapies in the pipeline in various stages of development include CAP-1002, Progenza, AGLE 102, ExoCoVac, COYA 201, EV-101, StemXO Endosome Therapy, BRE AD01, ILB 202, Zofin, exoSTING, ExoFlo, CARTISOME, BRE MI01, OS006, SBI-407, and others. In July 2024, Aruna Bio announced the issuance of a US Patent for the composition of matter for neural exosomes used to deliver therapeutics to the brain. The company is on a rack to initiate Phase Ib/IIa clinical trial of AB126 in acute ischemic stroke in the second half of 2024. In July 2024, ILIAS Biologics announced that it had received the final clinical study report (CSR) for ILB-202, a Phase I clinical trial completed in Australia in November last year. In April 2024, Biological Dynamics joined the growing list of customers adopting the ExoVerita Pro instrument, a cost-efficient, automated exosomal enrichment platform. In April 2024, EXO Biologics secures up to EUR 16 million in Series A funding for exosome therapeutic development and clinical supply. In April 2024, ExoXpert entered a strategic partnership with Neucore Bio to leverage ExoXpert's platform for the evaluation of advanced exosome loading. In April 2024, INOVIQ and Promega signed a global supply and distribution agreement for EXO-NET. Last year's company entered into a Co-Marketing agreement. In March 2024, VivaZome Therapeutics and La Trobe University collaborated to explore the therapeutic potential of extracellular vesicles in models of stroke in the laboratory of Professor Chris Sobey. In January 2024, Aegle Therapeutics announced positive 12-week data for the first patient enrolled in Phase I/IIa clinical trial of AGLE-102 for the treatment of severe second-degree burns. Request a sample and discover the recent advances in exosomes-based therapies @ Exosomes Pipeline Outlook The exosomes-based therapies pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage exosomes-based therapies, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the exosomes-based therapies pipeline landscape. Exosomes Overview Exosomes are small extracellular vesicles, typically ranging from 30 to 150 nanometers in diameter, that are secreted by various cell types. They play a crucial role in intercellular communication by facilitating the transfer of proteins, lipids, and RNA between cells. This process can influence various physiological and pathological conditions, including immune responses, cancer progression, and neurodegenerative diseases. By carrying bioactive molecules, exosomes can modulate the behavior of recipient cells, contributing to processes such as tissue repair, immune regulation, and the spread of cancer cells. Their ability to transport molecular cargo makes them a subject of extensive research, particularly in the context of disease mechanisms and therapeutic applications. In recent years, exosomes have garnered significant interest in the field of biomedicine as potential biomarkers for disease diagnosis and as vehicles for targeted drug delivery. Researchers are exploring their use in therapeutic strategies, such as the delivery of RNA-based therapies and proteins, due to their natural ability to evade the immune system and penetrate cellular membranes. Additionally, exosomes derived from stem cells or engineered for specific therapeutic purposes hold promise for regenerative medicine, offering a novel approach to enhance tissue regeneration and repair. The ongoing investigation into the biology of exosomes continues to reveal their multifaceted roles in health and disease, paving the way for innovative applications in diagnostics and therapeutics. Find out more about exosomes-based therapies @ Exosomes-based Therapies in Development A snapshot of the Exosomes-based Therapies Pipeline Drugs mentioned in the report: Learn more about the emerging Exosomes-based therapies @ Exosomes-based Therapies Clinical Trials Exosomes-based Therapies Therapeutics Assessment The exosome-based therapies pipeline report proffers an integral view of the emerging exosome-based therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Exosomes-based Therapies Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Cell replacements, Inflammation mediator modulators, Collagen type VII replacements, Immunosuppressants, NF-kappa B inhibitor Key Exosomes-based Therapies Companies: Capricor Therapeutics, Regeneus, Aegle Therapeutics, Innovex Therapeutics, Coya Therapeutics, EV Therapeutics, StemXO Therapeutics, Brexogen, ILIAS Biologics, Organicell Regenerative Medicine, Codiak BioSciences, Direct Biologics, Exostemtech, Brexogen, OmniSpirant, ShiftBio Inc., and others. Key Exosomes-based Therapies in Pipeline: CAP-1002, Progenza, AGLE 102, ExoCoVac, COYA 201, EV-101, StemXO Endosome Therapy, BRE AD01, ILB 202, Zofin, exoSTING, ExoFlo, CARTISOME, BRE MI01, OS006, SBI-407, and others. Dive deep into rich insights for exosomes-based therapies assessment, visit @ Exosomes-based Therapies Therapeutics Assessment Table of Contents For further information on the exosomes-based therapies pipeline therapeutics, reach out @ Exosomes-based Therapies Pipeline Landscape Related Reports Exosome Therapies Market Exosome Therapies Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key exosome therapies companies, including Direct Biologics, Capricor Therapeutics, Aegle Therapeutics, Vitti Labs, Rion, Aruna Bio, EXO Biologics, EV Therapeutics, ReNeuron, Coya Therapeutics, Evox Therapeutics , among others. Duchenne Muscular Dystrophy Market Duchenne Muscular Dystrophy Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key DMD companies, including FibroGen, Santhera Pharmaceutical, Italfarmaco, ReveraGen BioPharma, Cumberland Pharmaceuticals, Sarepta Therapeutics, Antisense Therapeutics, Capricor Therapeutics , among others. Duchenne Muscular Dystrophy Pipeline Duchenne Muscular Dystrophy Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Duchenne muscular dystrophy companies, including Santhera Pharmaceuticals, Sarepta Therapeutics, Italfarmaco, Wave Life Sciences Ltd, FibroGen, Edgewise Therapeutics, Pfizer, Daiichi Sankyo, Sarepta Therapeutics, Inc., ENCell, Taiho Pharmaceutical, Solid Biosciences, Capricor, Nippon Shinyaku, Hansa Biopharma, Ultragenyx Pharmaceutical, Dyne Therapeutics, Entrada Therapeutics, AAVogen, PepGen, Antisense Therapeutics, BioMarin Pharmaceutical, Avidity Biosciences, Sarepta Therapeutics, Dyne Therapeutics, Solid Biosciences Inc, Regenxbio, Stealth BioTherapeutics, among others. Atopic Dermatitis Market Atopic Dermatitis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key atopic dermatitis companies, including Arcutis Biotherapeutics, Amgen, Kyowa Kirin, Dermavant Sciences, Cara Therapeutics, Pfizer, Arena Pharmaceuticals, BioMimetix, Eli Lilly and Company, Aldeyra Therapeutics, Inc., Hangzhou Yirui Pharmaceutical Technology Co., Ltd, LEO Pharma, Corvus Pharmaceuticals, Inc., Brexogen Inc., Sanofi, Shaperon, UCB Pharma, Q32 Bio Inc., Akeso, Apogee Therapeutics, Inc., Allakos Inc., Biosion, Inc. , among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1

100 Deals associated with ILIAS Biologics, Inc.

100 Translational Medicine associated with ILIAS Biologics, Inc.

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Pipeline

Pipeline Snapshot as of 07 Aug 2026

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

Preclinical

Phase 1

Current Projects

Drug(Targets)	Indications	Global Highest Phase

ILB-202 ( NF-κB )	Glomerulonephritis More	Preclinical
ILB-332 ( NF-κB )	Chorioamnionitis More	Preclinical
Exo.anti-CARD9 ( CARD9 x TRIM62 )	Inflammatory Bowel Diseases More	Preclinical
ILB-323 ( NF-κB )	Neuralgia More	Preclinical
ILB-312 ( NF-κB )	Rheumatoid Arthritis More	Preclinical

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