iRegene Therapeutics Co., Ltd

The market for cell and gene therapy in Parkinson's disease is driven by the critical unmet medical need for disease-modifying treatments, advancements in clinical trials showing promising results, and regulatory support for innovative therapies. Additionally, the economic burden of managing PD and the rise in patient advocacy for cutting-edge solutions are further accelerating investment and development in this area. Together, these factors position cell and gene therapies as transformative in addressing the current treatment gaps in Parkinson's disease. LAS VEGAS, Oct. 9, 2024 /PRNewswire/ -- DelveInsight's ' Cell and Gene Therapy in Parkinson's Disease Pipeline Insight – 2024 ' report provides comprehensive global coverage of pipeline cell and gene therapy in Parkinson's disease in various stages of clinical development, major pharmaceutical companies working to advance the pipeline space and future growth potential of the cell and gene therapy in Parkinson's disease pipeline domain. Key Takeaways from the Cell and Gene Therapy in Parkinson's Disease Pipeline Report DelveInsight's cell and gene therapy in Parkinson's disease pipeline report depicts a robust space with 18+ active players working to develop 20+ cell and gene therapies for Parkinson's disease treatment. Key cell and gene therapy in Parkinson's disease companies such as Sumitomo Dainippon Pharma, BlueRock Therapeutics, Aspen Neuroscience, Prevail Therapeutics, S.Biomedics, MeiraGTx, Asklepios BioPharmaceutical, iRegene Therapeutics, Kenai Therapeutics, Tetraneuron, and others are evaluating new cell and gene therapy in Parkinson's disease to improve the treatment landscape. Promising pipeline cell and gene therapy in Parkinson's disease in various stages of development include CT1 DAP001/DSP 1083, BRT-DA01, ANPD 001, LY3884961, A9-DPC, AAV-GAD, AB-1005, NouvNeu 001, RNDP 003, TET AAV E2F4DN, and others. In July 2024, S.BIOMEDICS announced positive one-year assessment data from the first 3 participants (first low dose cohort) of Phase I/IIa clinical trial for Parkinson's disease with TED-A9, hESC (human embryonic stem cell)-derived midbrain dopaminergic progenitors. In July 2024, Bayer AG and Asklepios BioPharmaceutical announced that the United States (U.S.) Food and Drug Administration (FDA) had granted Fast Track Designation for AB-1005, which is being developed for moderate Parkinson's disease. In June 2024, The U.S. Food and Drug Administration (FDA) approved the IND application for NouvNeu001, a cell therapy product from iRegene therapeutics targeting Parkinson's Disease. Previously, the "Combined Phase I/II Clinical Study" of NouvNeu001 had already received approval from China NMPA in August 2023 and demonstrated positive safety and efficacy data in its Phase I trials. In May 2024, Bayer AG and BlueRock Therapeutics announced that BlueRock's investigational cell therapy bemdaneprocel for the treatment of Parkinson's disease had been granted Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA). In April 2024, Aspen Neuroscience, Inc. announced that the first patient had been dosed in the ASPIRO trial, a Phase I/IIa open label clinical trial to assess safety and tolerability of ANPD001, an autologous, dopaminergic neuron cell replacement therapy for participants with moderate to severe Parkinson's disease (PD). In March 2024, Bayer AG and BlueRock Therapeutics announced details of 18-month data from the phase I clinical trial for bemdaneprocel (BRT-DA01), an investigational allogeneic stem cell derived cell therapy for treating Parkinson's disease. In January 2024, Bayer AG and Asklepios BioPharmaceutical announced the completion of the 18-month data collection in the Phase Ib clinical trial for AB-1005 (AAV2-GDNF), an investigational gene therapy for treating patients with Parkinson's disease (PD).1, Request a sample and discover the recent advances in cell and gene therapy in Parkinson's disease drug treatment @ Cell and Gene Therapy in Parkinson's Disease Pipeline Report The cell and gene therapy in Parkinson's disease pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage cell and gene therapy in Parkinson's disease, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the cell and gene therapy in Parkinson's disease clinical trial landscape. Cell and Gene Therapy in Parkinson's Disease Overview Cell and gene therapy holds significant promise for treating Parkinson's disease, a neurodegenerative disorder characterized by the progressive loss of dopaminergic neurons in the brain. Cell therapy focuses on the transplantation of stem cells or progenitor cells into the brain to replace the lost neurons or support their survival. These transplanted cells can potentially differentiate into dopaminergic neurons, helping restore the dopamine levels that are crucial for motor control. Recent advances in induced pluripotent stem cells (iPSCs) have enabled the development of patient-specific neurons, which can minimize immune rejection and offer personalized treatment options. Early clinical trials have shown potential, though challenges remain in ensuring long-term survival and functionality of the transplanted cells. Gene therapy, on the other hand, aims to modify the genetic makeup of neurons to slow down or reverse the disease process. Techniques like viral vectors are used to deliver genes that can boost dopamine production, protect neurons from degeneration, or reduce the buildup of harmful proteins like alpha-synuclein, which is implicated in Parkinson's disease pathology. One notable example is the delivery of the GDNF (glial cell line-derived neurotrophic factor) gene, which has been shown to support the survival of dopaminergic neurons. Although gene therapy for Parkinson's disease is still in its experimental stages, it holds potential as a long-lasting and less invasive approach compared to traditional treatments like deep brain stimulation or dopamine replacement therapy. With ongoing advancements, both cell and gene therapies could revolutionize how Parkinson's disease is managed in the future. Find out more about cell and gene therapy in Parkinson's disease @ New Cell and Gene Therapies in Parkinson's Disease A snapshot of the pipeline Cell and Gene Therapy in Parkinson's Disease mentioned in the report: Learn more about the emerging cell and gene therapy in Parkinson's disease @ Cell and Gene Therapy in Parkinson's Disease Clinical Trials Cell and Gene Therapy in Parkinson's Disease Therapeutics Assessment The cell and gene therapy in Parkinson's disease pipeline report proffers an integral view of emerging cell and gene therapy in Parkinson's disease segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Cell and Gene Therapy in Parkinson's Disease Pipeline Report Coverage: Global Cell and Gene Therapy in Parkinson's Disease Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Cell and Gene Therapy in Parkinson's Disease Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Cell and Gene Therapy in Parkinson's Disease Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Cell and Gene Therapy in Parkinson's Disease Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Key Cell and Gene Therapy in Parkinson's Disease Companies: Sumitomo Dainippon Pharma, BlueRock Therapeutics, Aspen Neuroscience, Prevail Therapeutics, S.Biomedics, MeiraGTx, Asklepios BioPharmaceutical, iRegene Therapeutics, Kenai Therapeutics, Tetraneuron, and others. Key Cell and Gene Therapy in Parkinson's Disease Pipeline Therapies: CT1 DAP001/DSP 1083, BRT-DA01, ANPD 001, LY3884961, A9-DPC, AAV-GAD, AB-1005, NouvNeu 001, RNDP 003, TET AAV E2F4DN, and others. Dive deep into rich insights for new cell and gene therapy for Parkinson's disease treatment; visit @ Cell and Gene Therapy for Parkinson's Disease Treatment Table of Contents For further information on the cell and gene therapy in Parkinson's disease pipeline therapeutics, reach out @ Cell and Gene Therapy in Parkinson's Disease Drug Treatment Related Reports Cell and Gene Therapy in Parkinson's Disease Market Cell and Gene Therapy in Parkinson's Disease 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 cell and gene therapy in Parkinson's disease companies, including MeiraGTx, Hope Biosciences, Sumitomo Pharma, Prevail Therapeutics, BlueRock Therapeutics, Voyager Therapeutics, among others. Parkinson's Disease Pipeline Parkinson's Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Parkinson's disease companies, including Cerevel Therapeutics, Inhibikase Therapeutics, Neuraly, Peptron, Biogen, Roche, Brain Neurotherapy Bio, Inc., Modag, Annovis Bio Inc., BioVie Inc., United Neuroscience Ltd., Luye Pharma Group, AbbVie, UCB Biopharma SRL, InnoMedica Schweiz AG, Integrative Research Laboratories AB, H. Lundbeck A/S, Shanghai WD Pharmaceutical Co., Ltd., Cerevance Beta, Inc., Nobilis Therapeutics Inc., BlueRock Therapeutics, Taiwan Mitochondrion Applied Technology Co., Ltd., among others. Psychosis in Parkinson's and Alzheimer's Disease Market Psychosis in Parkinson's and Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key psychosis in Parkinson's and Alzheimer's disease companies, including Sunovion Pharmaceuticals, Karuna Therapeutics, Vanda Pharmaceuticals, Suven Life Sciences, Enterin, Intra-Cellular Therapies, Merck Sharp & Dohme, among others. Parkinson's Disease-Related Dementia Market Parkinson's Disease-Related Dementia Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease-related dementia companies, including AbbVie, UCB Biopharma SRL, InnoMedica Schweiz AG, Integrative Research Laboratories AB, H. Lundbeck A/S, Shanghai WD Pharmaceutical Co., Ltd., Cerevance Beta, 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

WUHAN, China, June 24, 2024 /PRNewswire/ -- On June 20 (UTC-4), the U.S. Food and Drug Administration (FDA) approved the IND application for NouvNeu001, a cell therapy product from iRegene therapeutics targeting Parkinson's Disease. This marks a significant milestone as NouvNeu001 becomes the world's first chemically induced allogeneic cell therapy product to enter clinical stages for Parkinson's disease in the US. Previously, the "Combined Phase I/II Clinical Study" of NouvNeu001 had already received approval from China NMPA in August 2023 and demonstrated positive safety and efficacy data in its Phase I trials. On June 20, 2024, iRegene further announced IND approval of NouvNeu001 by the U.S. FDA for the treatment of mid-to-late stage of Parkinson's disease. Notably, in March 2024, iRegene was granted the exemption from the FDA, highlighting the recognition of iRegene's pioneering platform and innovative production and quality systems. Dr. Cai Meng, the CMO of iRegene, emphasized that obtaining the exemption from the FDA, followed by the IND approval for NouvNeu001, underscores iRegene's professionalism in developing innovative chemically induction platform. This milestone also paves the way for subsequent international operations of iRegene. iRegene is among the early biotech companies globally to apply "AI + chemical induction" for the specific functional modification of cells. This platform offers significant advantages, including higher efficiency, safety, cost-effectiveness, and suitability for large-scale industrial production. Leveraging this unique platform, iRegene has developed a robust pipeline of universal iPSC derived cell products aimed at treating "incurable" diseases such as neurodegenerative disorders, including Parkinson's disease and blindness. Due to the originality of iRegene's technological platform and the strong advantages demonstrated in product development, the FDA granted a special exemption for iRegene's groundbreaking product in March 2024. In early 2024, clinical trials for NouvNeu001 were successfully initiated at Beijing Hospital and Zhongnan Hospital of Wuhan University in China. By integrating the advantageous clinical resources of neurosurgery, neurology, and other departments, a systematic evaluation of the safety, tolerability, and efficacy of stereotactic bilateral intracerebral injections of NouvNeu001 for mid-to-late stage Parkinson's disease is being conducted. The clinical project is currently in its acceleration stage. Preliminary results from the ongoing multicenter clinical study have indicated that the patients received NouvNeu001 showed consistently significant improvements in MDS-UPDRS Part III (motor) scores, and good safety with no cell product related adverse effects. Following the significant progress of the NouvNeu001 clinical trial and the preliminary positive efficacy and safety data, iRegene will soon commence patient recruitment for the clinical trial of its early-onset Parkinson's disease product, NouvNeu003, which was also approved by China NMPA in December 2023. Beyond neurodegenerative diseases, iRegene continues to explore other "incurable" diseases. On March of this year, iRegene's breakthrough ophthalmic product, NouvSight001, was granted Orphan Drug Designation (ODD) by the FDA. This product targets retinal diseases and is a first of its kind induced pluripotent stem cell (iPSC)-derived ophthalmic allogeneic cell therapy developed by iRegene's team also from company's unique "AI+ chemical induction" platform. Dr. Wei Jun, CEO of iRegene, highlighted that the team's efforts in maintaining rigorous standards of innovative products while ensuring steady progress in R&D. The project advancement plan previously set by iRegene is scheduled to the "week", laying an indispensable foundation for the timely clinical entry of core pipelines. "On the basis of cautious and robust R&D efforts, iRegene aims to leverage its innovative technologies to bring breakthroughs for a multitude of currently incurable diseases, bringing hope to patients and families deeply affected by these conditions. Dual approval of IND applications of NouvNeu001 by the U.S. FDA and China NMPA further boosts the confidence of iRegene's global team in building a world-class innovative platform," said Dr. Wei Jun. About NouvNeu001 NouvNeu001 is a chemically induced human dopaminergic neuron precursor derived from iPSC, with iRegene Therapeutics wholly owned proprietary. NouvNeu001 is the world's first iPSC-derived and chemically induced allogeneic cell therapy product for clinical application. On August 2, 2023, the National Medical Products Administration (NMPA) of China officially approved the Phase I/II clinical trial of NouvNeu001, designed to assess the safety, tolerability and efficacy in treating mid-to-late Parkinson's disease. The clinical trial commenced successfully in January 2024 at Beijing Hospital. More information about this trial is available at clinicaltrials.gov (NCT#06167681). Furthermore, the clinical trial application was approved by FDA on 20th, June, 2024. About iRegene Therapeutics iRegene Therapeutics is the earliest biotech company in the world focusing on accurately reprograming cell fate and functions by chemicals. Leveraging its unique "AI + chemical induction" platform, iRegene Therapeutics has developed extensive pipelines of universal iPSC-derived cell products. The company is dedicated to advancing universal cell therapy products and introducing novel cell replacement therapy for "incurable" neurodegenerative diseases, including Parkinson's disease and retinal diseases.

WUHAN, China, Feb. 5, 2024 /PRNewswire/ -- iRegene Therapeutics Co., Ltd (iRegene) recently announced that NouvNeu001, the company's first innovative product, has completed the dosing for its first patient at Beijing Hospital, and the patient has also successfully concluded the observation period. It is reported that the multicenter, open-label clinical trial (Phase I/II) is meticulously crafted to systematically evaluate the safety, tolerability, and efficacy of stereotactic bilateral intracerebral injection of NouvNeu001 for treating moderate to advanced Parkinson's disease. So far, the Phase I clinical trial has been successfully initiated at both Beijing Hospital (Beijing, PRC) and Zhongnan Hospital (Wuhan, PRC), with dosing completed for its first patient. Dr. Cai, CMO of iRegene, said that the completion of the first patient dosing and the successful observation period marks an important milestone in the development of iRegene Therapeutics. Publicly available information reveals that the NouvNeu001 is a chemically induced human dopaminergic neuron precursor from iPSC, with iRegene Therapeutics wholly owned proprietary. NouvNeu001 is the world's first iPSC-based and chemically induced universal cell therapy product. This product attains high-purity reconstruction and functional optimization of neuronal subtypes via chemical induction. Upon transplantation, it establishes connections with the body's existing neurons and augments cellular secretion functions, thereby reinforcing the transplanted cells' ability to improve the original lesion. In this way, it can provide comprehensive therapeutic effects. On August 2, 2023, the National Medical Products Administration (NMPA) of China officially approved the Phase I/II clinical trial of NouvNeu001, designed to assess the safety, tolerability and efficacy in treating moderate to advanced Parkinson's disease. The clinical trial commenced successfully in early January 2024 at Beijing Hospital. More information about this trial is available at clinicaltrials.gov (NCT#06167681). iRegene Therapeutics, the pioneering biotech company behind NouvNeu001, stands as one of the global frontrunners in harnessing "AI + chemical induction" for cell-specific functional remodeling. Leveraging its unique "AI + chemical induction" platform, iRegene Therapeutics has developed an extensive pipeline of universal iPSC-derived products. The company is dedicated to advancing universal cell therapy products and introducing novel treatment alternatives for traditionally "incurable" neurodegenerative diseases, including Parkinson's disease and blindness. About NouvNeu001 NouvNeu001 is a chemically induced human dopaminergic neuron precursor from iPSC, with iRegene Therapeutics wholly owned proprietary. NouvNeu001 is the world's first iPSC-based and chemically induced universal cell therapy product. On August 2, 2023, the National Medical Products Administration (NMPA) of China officially approved the Phase I/II clinical trial of NouvNeu001, designed to assess the safety, tolerability and efficacy in treating moderate to advanced Parkinson's disease. The clinical trial commenced successfully in early January 2024 at Beijing Hospital. More information about this trial is available at clinicaltrials.gov (NCT#06167681). About iRegene Therapeutics iRegene Therapeutics, is the earliest biotech company in the world focusing on accurately reprograming cell fate and functions by chemicals. Leveraging its unique "AI + chemical induction" platform, iRegene Therapeutics has developed an extensive pipeline of universal iPSC-derived products. The company is dedicated to advancing universal cell therapy products and introducing novel treatment alternatives for "incurable" neurodegenerative diseases, including Parkinson's disease and blindness. SOURCE iRegene Therapeutics Co., Ltd