With the rapid progress in the organoid field, organoids have been included in the national agenda due to their high level of genetic, structural, and functional replication and similarity."In the '14th Five-Year Plan' key special project application guide, it has also been recognized by the U.S. FDA, and may potentially replace animal models for...VerificationThe Human Body's Response to Potential TherapiesReaction。

iRegene's Integrated Organoid R&D Platform (iReOrgan) Aligns with Current Development Trends and Will Bring a Milestone Shift in Screening Models. Currently, iRegene's integrated organoid R&D platform has the capability to construct various organoid systems and has achieved scaled-up cultivation, providing strong support for high-throughput screening of precision drugs.

At 19:30 on July 29 (Monday), the 80th episode of VCBeat's New Product Review invited iRegene.CEO of Jianyi Medicine Wei Jun, R&D Director of iRegene Yan Ruorong, bringing the product promotion of iRegene.

iRegene's R&D team has long-term accumulation in the fields of chemical induction, developmental biology, and pluripotency regulation. They have established an integrated proprietary platform for organoid development, completed the world’s first chemically induced drug targeting Parkinson’s disease, and advanced it to the clinical stage. This platform addresses gaps and deficiencies in the safety and efficacy evaluation systems for innovative drugs, ensuring the drug’s effectiveness and safety during the clinical phase.

· Globally pioneering chemical induction technology

iRegene has established an integrated organoid R&D platform (iReOrgan) based on "AI + chemical induction." The organoid models generated by this platform can not only provide disease characterization but also reflect the spatiotemporal progression of diseases, making them a rare variety of organoids currently available in the market.

· Construction of a New High-Throughput Organoid Screening System

The existing iReOrgan platform has achieved scaled-up cultivation, developing a series of complex organoids and their derivative disease models, including whole-brain organoids, midbrain organoids, heart organoids, and more. It is capable of completing high-throughput screening and validation of candidate drugs while constructing models. Specific features include:

Breaking traditional techniques, without relying on geometric, scaffold, matrix gel, and other tissue engineering technologies, the key genes are regulated through compounds, autonomously forming tissue structures and functions that replicate in vivo development. Among these, the iRegene brain system (whole brain) has a refined cortical structure and cell populations similar to natural brain tissues; the iRegene cardiac system is an in vitro heart organoid model with chambers, reproducing the crucial ventricular formation process during in vivo heart development.

The brain-like system (whole brain) obtained on the iReOrgan platform can simultaneously generate various types of brain cells, forming a symbiotic structure of neurons and glial cells similar to the human brain; the obtained heart-like system contains multiple cell types such as ventricular muscle cells, atrial muscle cells, vascular endothelial cells, and smooth muscle cells.

The brain-like system (whole brain) obtained on the iReOrgan platform exhibits stable electrophysiological activity; the brain-like system (midbrain) possesses neurotransmitter secretion function; the heart-like system can sustain autonomous beating after induction. A series of organoid models generated by this platform provide support for screening and safety evaluation of neurotoxicity and cardiotoxicity of drugs.

· Scalable Cultivation

· Can achieve fine-grained functionality

· Mature Modeling System

· Capable of Deep Live Imaging

· Enables high-throughput screening

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Wei Jun

iRegene CEO

Dr. Jun Wei is the co-founder and CEO of Wuhan iRegene Therapeutics, and also a guest researcher in Clinical Neuroscience at the University of Cambridge, UK. He completed his master's and doctoral studies at Yale University and the University of Bath, UK, respectively. Afterward, he has worked for many years in the industry, engaging in cutting-edge research, application transformation, and senior management at institutions such as the Roslin Institute at the University of Edinburgh, the University of Cambridge, and Axol Bio. His work has successively received awards from institutions such as the Rockefeller Foundation (US), the UK ORS, the British Society for Cell Biology, the British Society for Developmental Biology, and European ELRIG.

iRegene is one of the earliest biotechs globally to apply "AI + chemical induction" to the specific functional modification of cells. Its first product, "NouvNeu001," was approved by the China National Medical Products Administration in August 2023 to enter the clinical stage, becoming the world's first new Parkinson's disease therapy derived from induced pluripotent stem cells.

Yan Ruo Rong

iRegene R&D Director

Dr. Yan Ruorong is the R&D Director of Wuhan iRegene Therapeutics. She obtained her Ph.D. from the School of Basic Medical Sciences at Peking University and completed her postdoctoral research at Duke University in the United States. With over 10 years of experience in tissue regeneration and in vivo model construction, she has led or participated in several national-level projects and published more than 10 papers in international journals such as Cell Stem Cell and Genes & Development. At iRegene, she leads the development of multiple key platforms and the advancement of R&D projects.

iRegene, as one of the earliest biotech companies globally to apply "AI + chemical induction" to the specific functional modification of cells, has established a rich pipeline of universal iPSC products on this unique platform. It aims to develop universal cell therapy products for currently "incurable" diseases such as Parkinson's disease and blindness, offering new treatment solutions. iRegene utilizes "AI + chemical induction" as a development platform for the precise directional modification of cell functions, enabling the efficient conversion of induced pluripotent stem cells (iPSCs) and ensuring drug feasibility. Its first product, NouvNeu001, the world’s first universal chemically induced product in the Parkinson’s field, received NMPA approval in China to enter combined Phase I-II clinical trials in August 2023. Additionally, it achieved dual IND approvals in both China and the U.S. for the Parkinson’s pipeline.

 "VCBeat New Product Review" is a live broadcast column under VCBeat that assists medical companies in launching innovative products. The column's mission is: to support every milestone release of medical innovation products.

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