Remyelination

Progentos Therapeutics Closes $65 Million Series A Financing to Advance Treatments for Multiple Sclerosis and Other Degenerative Diseases

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måndag, maj 20, 2024
Health, Other Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Patient, Survival, Entrepreneurship, Therapy, Remyelination, Disease, Census of agriculture, Multiple sclerosis, Alta Partners, Myelin, Disability, Axon

Progentos Therapeutics, a biotech company addressing the critical unmet need to regenerate myelin and restore function for patients with Multiple Sclerosis (MS) and other demyelinating diseases, today announced its launch and the closing of a $65 million series A round.

Key Points: 
  • Progentos Therapeutics, a biotech company addressing the critical unmet need to regenerate myelin and restore function for patients with Multiple Sclerosis (MS) and other demyelinating diseases, today announced its launch and the closing of a $65 million series A round.
  • This funding will enable Progentos to advance its MS program through human proof of concept studies and expand its pipeline in additional degenerative diseases.
  • Progentos is developing first-in-class small molecules designed to induce remyelination of axons affected by MS.
  • “We are truly excited to be part of Progentos’ journey towards delivering potentially disease-modifying drugs for diseases like multiple sclerosis, diseases with high unmet clinical needs.

Clene Reports First Quarter 2024 Financial Results and Recent Operating Highlights

Retrieved on: 
onsdag, maj 8, 2024
CNM, Remyelination

Additionally, we are very pleased to see the recent data from our long-term extension of the VISIONARY-MS study.

Key Points: 
  • Additionally, we are very pleased to see the recent data from our long-term extension of the VISIONARY-MS study.
  • The presentation of Visionary-MS long-term extension results presented at the 2024 AAN Annual Meeting is available here.
  • Clene expects that its resources as of March 31, 2024, will be sufficient to fund its operations into the fourth quarter of 2024.
  • Research and development expenses were $5.9 million for the quarter ended March 31, 2024, compared to $7.4 million for the same period in 2023.

Small Molecule Shows Early-Stage Promise for Repairing Myelin Sheath Damage

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torsdag, maj 2, 2024
Nerve, Brain, Enzyme, University, Cell nucleus, Mouse, Tissue, H3K9me3, Organoid, Thought, H3K27ac, Doctor of Philosophy, Axon, Research, Remyelination, Disease, OLS, Cholesterol, Movement, Gene expression, Multiple sclerosis, Regeneration, Ageing, H3K27me3, Tetraplegia, Pharmaceutical industry

CINCINNATI, May 2, 2024 /PRNewswire/ -- When treated with a novel protein function inhibitor called ESI1, mice that mimic the symptoms of multiple sclerosis (MS) and lab-prepared human brain cells both demonstrated the ability to regenerate vital myelin coatings that protect healthy axon function.

Key Points: 
  • When the protective myelin gets damaged, be it by disease or the wear and tear of age, nerve signaling gets disrupted.
  • Pinning down the genetic changes and signals involved in the repair silencing process and finding a small molecule compound that can reverse the silencing was a complex undertaking.
  • In both aging mice and mice mimicking MS, the ESI1 treatment prompted myelin sheath production and improved lost neurological function.
  • When the organoids were exposed to ESI1, the treatment extended the myelin sheath of myelinating cells, the study reports.

Evidence for Clene’s CNM-Au8® as a Treatment for Repair and Remyelination in Multiple Sclerosis Presented in the Emerging Science Session at the 2024 American Academy of Neurology Annual Meeting

Retrieved on: 
tisdag, april 16, 2024
CNM, Remyelination

These new long-term results from the Phase 2 VISIONARY-MS clinical trial demonstrated evidence supporting repair and remyelinating effects of CNM-Au8 treatment in patients originally randomized to CNM-Au8.

Key Points: 
  • These new long-term results from the Phase 2 VISIONARY-MS clinical trial demonstrated evidence supporting repair and remyelinating effects of CNM-Au8 treatment in patients originally randomized to CNM-Au8.
  • The significant and concordant results across multiple paraclinical exploratory endpoints reinforce the evidence for sustained clinical benefit to study participants across multiple clinical outcome measures, associated with consistent improvements in neuronal function and remyelination.
  • “Phase 2 CNM-Au8 VISIONARY-MS Trial: Long-Term Extension Results” presentation key highlights:
    Participants originally randomized to CNM-Au8 treatment experienced continued significant improvement in vision as measured by low contrast letter acuity.
  • MRI measures of axial diffusivity showed significant improvements in T2 brain lesions in study participants treated with CNM-Au8 (MMRM vs. original baseline, p

SetPoint Medical Accepted into FDA Total Product Life Cycle Advisory Program for Development of its Neuroimmune Modulation Platform for the Treatment of Multiple Sclerosis

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torsdag, mars 21, 2024
Research, Medical Devices, Neurology, FDA, Genetics, Clinical Trials, Biotechnology, General Health, Health, Science, Vagus nerve, Device, CDRH, Patient, Regulatory affairs, TAP, Remyelination, Clinical trial, Safety, Set, RRMS, Food, Pharmaceutical industry

SetPoint Medical , a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has been accepted into the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot from the U.S. Food and Drug Administration (FDA) for the development of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS).

Key Points: 
  • SetPoint Medical , a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has been accepted into the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot from the U.S. Food and Drug Administration (FDA) for the development of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS).
  • The FDA’s Center for Devices and Radiological Health (CDRH) launched the TAP Pilot to help expedite development and patient access to safe and effective high-quality medical devices upon FDA approval.
  • In October 2023, the FDA expanded the program to include neurological and physical medicine devices.
  • SetPoint's integrated neurostimulation device uses precise vagus nerve stimulation to activate innate anti-inflammatory and immune-restorative pathways to treat autoimmune conditions.

SetPoint Medical Receives FDA Breakthrough Device Designation for its Neuroimmune Modulation Platform for the Treatment of Multiple Sclerosis

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onsdag, mars 13, 2024
Medical Devices, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Vagus nerve, Neurology, Brain, Rheumatoid arthritis, Communication, Multiple sclerosis, Patient, Myelin, Remyelination, Neck, Axon, Clinical trial, Johns Hopkins University, Pain, Nerve, Fatigue, Set, FDA, Visual impairment, RRMS, Food, Pharmaceutical industry

SetPoint Medical , a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS).

Key Points: 
  • SetPoint Medical , a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS).
  • Breakthrough Device Designation will enable interactive communication and priority regulatory review with the FDA, and support reimbursement and patient access upon FDA approval of SetPoint’s technology.
  • This Breakthrough Device Designation is based on evidence demonstrating that SetPoint's treatment has the potential to reduce demyelination and promote remyelination.
  • In 2020, the FDA also granted Breakthrough Device Designation to SetPoint's device for the treatment of rheumatoid arthritis (RA).

Myrobalan Therapeutics Completes Series A Financing of $24 Million to Develop Potentially First-in-Class CNS Therapeutics with Restorative Potential

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onsdag, januari 10, 2024
Health, Neurology, Research, Pharmaceutical, Science, Biotechnology, Constellation, Patient, Therapy, Biology, Remyelination, Drug design, ALS, Broad Institute, Multiple sclerosis, Partnership, Harvard Medical School, National academy, GPR17, Venture, Neuroinflammation, MIT, Sympathetic nervous system, Drug development, TYK2, Traffic barrier, Harvard University, Capital, Limited partnership, CNS, Pharmaceutical industry

Myrobalan has the potential to overcome such obstacles with the development of highly selective, brain-penetrant, orally available compounds against promising novel targets involved in demyelination and neuroinflammation.

Key Points: 
  • Myrobalan has the potential to overcome such obstacles with the development of highly selective, brain-penetrant, orally available compounds against promising novel targets involved in demyelination and neuroinflammation.
  • These currently untreatable disease mechanisms have been linked to multiple sclerosis (MS), Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS), and several rare neurological conditions.
  • “Our deep understanding of remyelination and neuroinflammation has broad application in high-unmet need CNS diseases,” said Dr. Jing Wang, CEO & Co-Founder, Myrobalan Therapeutics.
  • Myrobalan Therapeutics' unique strategy holds great promise in overcoming challenges associated with central nervous system diseases.

INmune Bio Inc. Announces Third Quarter 2023 Results and Provides Business Update

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onsdag, november 1, 2023
Research, AD, Food, Health care, Biomarker, ATCC, Macrophage, World Intellectual Property Organization, Data, White matter, Phase, MHRA, MRI, MDS, CELL, Hereditary leiomyomatosis and renal cell cancer syndrome, Prostate cancer, Dementia, China International Search and Rescue Team, ATCC (company), Phagocytosis, EEG, Cancer, Patient, MS, BOCA, Human, Neurodegenerative disease, Conference, CTA, Patent Cooperation Treaty, AAIC, PCT, NK, Brain, Remyelination, Grey, AML, Carcinoma, FDA, IND, Medication, CNS, Treatment-resistant depression, Drug development, Pharmacotherapy, Neuroinflammation, WIPO, Cross, Cognition, Vaccine, Pharmaceutical industry, Medical imaging, Cryptocurrency, Health, Immunotherapy, Disease

BOCA RATON, Fla., Nov. 01, 2023 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announces its financial results for the quarter ended September 30, 2023 and provides a business update.

Key Points: 
  • BOCA RATON, Fla., Nov. 01, 2023 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announces its financial results for the quarter ended September 30, 2023 and provides a business update.
  • Recruitment of the trial is increasing and the company anticipates results of the Phase II program towards the end of 2024.
  • Other expense was approximately $0.0 million for the quarter ended September 30, 2023, compared to approximately $0.3 million during the quarter ended September 30, 2022.
  • Please ask for the INmune Bio Third Quarter Conference Call when reaching an operator.

INmune Bio Inc. Presents Preclinical Data at SITC 2023 Showing INB03 is an Innate Immune Check Point Inhibitor that Downregulates SIRPα

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måndag, oktober 30, 2023
Neoplasm, PD-L1, Trastuzumab, AD, Therapy, TNF, Macrophage, CD47, Research, Poster, Society for Immunotherapy of Cancer, CD8, Mouse, LAG3, Disease, Breast cancer, ADCP, Microglia, Brain, Tumor microenvironment, Phagocytosis, Safety, DMD, Cancer, Remyelination, Instituto de Biología y Medicina Experimental, Society, TME, MS, Vaccine, Medical imaging, Immunotherapy

Boca Raton, Florida, Oct. 30, 2023 (GLOBE NEWSWIRE) --   INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, is presenting data on the use of INB03, a dominant-negative inhibitor of soluble TNF in the treatment of high-risk MUC4 expressing HER2+ breast cancer. Roxana Schillaci Ph.D. of Instituto de Biología y Medicina Experimental in Buenos Aries, Argentina, will present her work at the 38th annual Society of Immunotherapy in San Diego, California which runs from November 1-4.

Key Points: 
  • INB03 downregulates expression of SIRPα on macrophages promote increased cancer cell death by antibody dependent cellular phagocytosis (ADCP).
  • The poster entitled “INB03: a new immune checkpoint inhibitor that reprograms polarization and promotes ADCP in human macrophages,” shows that INB03 is an innate immune checkpoint inhibitor working through the SIRPα-CD47 pathway to promote ADCP.
  • INB03 downregulates SIRPα expression to eliminate the “don’t eat me signal” and promote ADCP.
  • INB03 neutralizes sTNF, repolarizing tumor protecting M2 macrophages to M1 anti-tumor macrophages, enhances ADCP with trastuzumab, and reduces SIRPα expression.

INmune Bio Inc. Presents New Biomarker and Feasibility Data from Phase 1b Study Supporting the Use of XPro™ to Treat Alzheimer’s Disease at Clinical Trials on Alzheimer’s Disease (CTAD) Conference

Retrieved on: 
tisdag, oktober 17, 2023
Cross, Drug development, Biology, Brain, Trial of the century, CNS Drugs (journal), Remyelination, Proteome, Neurology, MOA, Clinical trial, Pharmacotherapy, Disease, EEG, CSF, Diffusion, Tau, Grey, MRI, Neuroinflammation, Patient, Cumulus cloud, Medical imaging, Pharmaceutical industry

Boca Raton, Florida, Oct. 17, 2023 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, highlights some important findings from data presented at the 16th annual Clinical Trial in Alzheimer’s Disease (CTAD) to be held October 24-27 in Boston, MA.

Key Points: 
  • INmune is enrolling AD patients into a global, blinded, randomized Phase II trial.
  • “The Phase Ib trial was designed to demonstrate that XPro™ reverses neuroinflammation and has been confirmed by previously presented data ,” said CJ Barnum Ph.D., VP of CNS Drug Development at INmune Bio.
  • P055: Changes in cortical microstructure in brain regions associated with cognitive status and disease duration after short-term treatment with XPro1595 for Alzheimer’s disease.
  • A goal of our Phase II study in Early AD patients is to correlate these biologic changes with cognitive function.”