Remyelination

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

Retrieved on: 
Thursday, March 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

Retrieved on: 
Wednesday, March 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

Retrieved on: 
Wednesday, January 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

Retrieved on: 
Wednesday, 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

Retrieved on: 
Monday, October 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: 
Tuesday, October 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.”

Frequency Therapeutics Provides Business Updates and Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 10, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, CVR, RNA, Multiple sclerosis, Remyelination, Development, State Administrative Expenses, Administration, Frequency, Therapy, RNA editing, Cryptocurrency, Pharmaceutical industry, Rare-earth element

Frequency Therapeutics, Inc. (Nasdaq: FREQ) today announced business updates and financial results for the second quarter ended June 30, 2023.

Key Points: 
  • Frequency Therapeutics, Inc. (Nasdaq: FREQ) today announced business updates and financial results for the second quarter ended June 30, 2023.
  • Frequency Therapeutics continues to explore strategic alternatives for its pre-clinical remyelination program for multiple sclerosis.
  • The CVR would represent the right to receive certain cash payments from proceeds received by Frequency Therapeutics related to the program.
  • Cash Position: As of June 30, 2023, Frequency had cash, cash equivalents and marketable securities of $46.5 million (excluding restricted cash).

Pipeline Therapeutics Announces First Subject Dosed with PIPE-791 in Phase 1 Study

Retrieved on: 
Tuesday, August 1, 2023
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MS, FDA, Therapy, Senior, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, LPA1, Food, Remyelination, Safety, CNS, Pharmaceutical industry, Pipeline

Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, today announced that the first subject was dosed in the Phase 1 clinical trial of PIPE-791 in healthy volunteers.

Key Points: 
  • Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, today announced that the first subject was dosed in the Phase 1 clinical trial of PIPE-791 in healthy volunteers.
  • PIPE-791 is a potent, selective and brain-penetrant small molecule antagonist of the lysophosphatidic acid 1 receptor (LPA1).
  • “Initiating dosing in this first in human study with PIPE-791 is a significant milestone for Pipeline that brings us one step closer to transforming the treatment of CNS indications by addressing both remyelination and neuroinflammation,” said Carmine Stengone, President and CEO of Pipeline.
  • We expect to fully enroll the study by the end of 2023.”

Synaptogenix and Cleveland Clinic to Submit Investigational New Drug (IND) Application to FDA for Clinical Trial of Bryostatin-1 in Multiple Sclerosis

Retrieved on: 
Wednesday, July 19, 2023
Learning, US Food Sovereignty Alliance, Cleveland Clinic, Therapy, Cognitive deficit, Drug discovery, Clinical trial, Deficit spending, Research, Brain, Multiple sclerosis, Remyelination, MS, MRI, Barrow Neurological Institute, Regeneration, Fragile X syndrome, MD, Immune system, Synapse, Protein kinase C, Principal, Magnetic resonance imaging, IND, Memory, Alzheimer's disease, Food, Safety, Disease, Pharmaceutical industry

NEW YORK, July 19, 2023 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the "Company"), an emerging biopharmaceutical company developing regenerative therapeutics for neurodegenerative disorders, today announced that it entered into an agreement with Cleveland Clinic to conduct a phase 1 trial of Bryostatin-1 in multiple sclerosis (MS). Cleveland Clinic will manage the clinical trial's implementation, including an Investigational New Drug (IND) submission to the US Food and Drug Administration and patient enrollment.

Key Points: 
  • Cleveland Clinic will manage the clinical trial's implementation, including an Investigational New Drug (IND) submission to the US Food and Drug Administration and patient enrollment.
  • "Cognitive impairment is a major unmet need in the treatment of people living with MS and we look forward to exploring the potential impact of this investigational drug."
  • Dr. Alan Tuchman, Chief Executive Officer of Synaptogenix, added, "We are moving forward with our clinical development plans for Bryostatin-1 in MS in collaboration with Cleveland Clinic.
  • The planned clinical trial will be held at Cleveland Clinic Neurological Institute's Mellen Center for Multiple Sclerosis, one of the largest and most comprehensive programs for MS care and research worldwide.

INmune Bio Inc. Announces Data Presented at the 16th European Meeting on Glial Cells in Health and Disease Shows that XPro™ Promotes Remyelination by Affecting Astroglial and Microglial Biology

Retrieved on: 
Monday, July 10, 2023
Retina, Tissue, Smell, Neuron, TNFR1, TNF, GFAP, Ear, Axon, Pathology, Brain, Biomarker, Multiple sclerosis, Astrocyte, Remyelination, MS, Nose, Regeneration, Pharmacotherapy, Hearing, Drug development, Biology, Mouse, Microglia, Allograft inflammatory factor 1, Skin, Disease, Medical imaging

Boca Raton, Florida, July 10, 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, announces important findings from data presented at The 16th European Meeting on Glial Cells in Health and Disease.  The conference runs July 8-12 in Berlin, Germany.

Key Points: 
  • Any damage to the myelin sheath compromises axon function preventing nerve cells from communicating and can result in nerve cell death.
  • Although the pathology of demyelination is easy to see, the biology of demyelination and remyelination is poorly understood.
  • The third surprise is that traditional biomarkers of astroglial and microglial activation, GFAP and Iba1 respectively, are increased in these myelin-promoting glial cells.
  • Therapeutic modulation of solTNF-TNFR1 signaling selectively in microglia promotes remyelination in the cortical grey matter.