Neuroinflammation

Vaccinex Reports 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, April 2, 2024
8-K, Research, Cash, Prevalence, HNSCC, Patient, Biomarker, Microglia, Sale, Nature, Form 10-K, Cancer, Neuroinflammation, Neuron, Neoplasm, Cognition, Drug development, Head and neck cancer, Astrocyte, PFS, Security, Neurodegenerative disease, Pharmaceutical industry

ROCHESTER, N.Y., April 02, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D, today announced financial results for the fourth quarter ended December 31, 2023 and provided a corporate update on key programs.

Key Points: 
  • ROCHESTER, N.Y., April 02, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D, today announced financial results for the fourth quarter ended December 31, 2023 and provided a corporate update on key programs.
  • Vaccinex achieved several important clinical milestones for pepinemab in both Alzheimer’s disease and Head and Neck Cancer.
  • Financial Results for the Year Ended December 31, 2023:
    Cash and Cash Equivalents and Marketable Securities.
  • The Company effected a 1-for-15 reverse stock split in Q3 2023 and 1-for-14 reverse stock split in Q1 2024.

Trevena Reports Fourth Quarter 2023 Results and Provides Corporate Update

Retrieved on: 
Monday, April 1, 2024
Blood pressure, EEG, Epilepsy, Bradycardia, Trevena, Rat, Neuropathic pain, Seizure, Central nervous system, Patient, CNS, TMS, Hospital, Sale, Chronic pain, NIH, IND, POC, Safety, Astrocyte, Status epilepticus, Neuroinflammation, Pharmaceutical industry

CHESTERBROOK, Pa., April 01, 2024 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported its financial results for the fourth quarter ended December 31, 2023 and provided an overview of its recent operational highlights.

Key Points: 
  • Given performance to date, we are reducing commercial support and reviewing alternatives for OLINVYK to preserve capital,” said Carrie Bourdow, President and CEO of Trevena.
  • OLINVYK will remain available for purchase by customers, who can continue to order the product through their normal channels.
  • In a review of safety and tolerability across both studies, TRV045 was well tolerated with results generally consistent with prior first-in-human studies.
  • For the fourth quarter of 2023, the Company reported a net loss attributable to common stockholders of $16.5 million, or $1.06 per share, compared to $7.0 million, or $0.73 per share in the fourth quarter of 2022.

Attovia Enhances Clinical and Development Expertise with Appointment of Chief Medical Officer and Clinical and Scientific Advisory Boards

Retrieved on: 
Tuesday, March 26, 2024
Tao, Internal medicine, Professor, Patient, Pulmonology, Executive Committee, Drug, Therapy, Chairperson, Sensation, Genentech, NSW, St George's Hospital, Harvard University, MTR, Pediatrics, Stanford University, Teaching hospital, Critical care, Outline of health sciences, KCP, Neuroinflammation, UCSF, Research, Acquisition, University, Management, MPH, Drug development, Atopic dermatitis, Entrepreneurship, Critical Care Medicine (journal), Adolescence, Contact dermatitis, Science, Division, KRYS, Pharmaceutical industry

FREMONT, Calif., March 26, 2024 (GLOBE NEWSWIRE) -- Attovia Therapeutics today announced the appointment of Hubert Chen, M.D., MPH, as Chief Medical Officer, effective March 21, 2024. Dr. Chen brings extensive clinical and industry leadership experience in drug development and joins Attovia from Krystal Biotech (NASDAQ: KRYS), where he was Senior Vice President of Clinical Development. At Attovia, Dr. Chen will lead the company’s clinical development and regulatory functions and will serve on the Executive Committee.

Key Points: 
  • Dr. Chen brings extensive clinical and industry leadership experience in drug development and joins Attovia from Krystal Biotech (NASDAQ: KRYS), where he was Senior Vice President of Clinical Development.
  • At Attovia, Dr. Chen will lead the company’s clinical development and regulatory functions and will serve on the Executive Committee.
  • Prior to Krystal, Dr. Chen was at Genentech/Roche where he held clinical leadership positions across both early and late-stage development.
  • To support the ongoing strategic development of the Attobody platform and advancement of the Company’s emerging pipeline candidates, Attovia has established Clinical and Scientific Advisory Boards comprised of biopharmaceutical industry veterans and academic experts.

BrainStorm Cell Therapeutics Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Phase 3b Trial in ALS

Retrieved on: 
Tuesday, April 9, 2024
Neurology, Neuroprotection, Element, Conference call, Institutional review board, Cerebrospinal fluid, Survival, Disease, ALS, SPA, Bone marrow, CSF, Data monitoring committee, Webcast, Patient, Protocol, Biomarker, Mortality, Microsoft Exchange Server, Stem cell, DMC, Screening, Agency, Safety, CAFS, Brainstorm, Therapy, Marketing, FDA, BLA, Neuroinflammation, Food, Pharmaceutical industry

NEW YORK, April 9, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS). 

Key Points: 
  • (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS).
  • The SPA agreement with the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating their adequacy for addressing objectives that support a future BLA (Biologics License Application) in ALS.
  • We appreciate the Agency's engagement and guidance during the SPA process and look forward to moving forward with the study."
  • The Phase 3b trial (Study BCT-006-US) will be a two-part, multicenter, study designed to assess the efficacy and safety of NurOwn in patients with ALS.

Cerevance Announces Presentation at Alzheimer’s Research UK Conference

Retrieved on: 
Wednesday, March 13, 2024
Brain, Conference, ALS, Central nervous system, CNS, Microglia, NLRP3, KCNK13, Frontotemporal dementia, Poster, Therapy, Neuroinflammation, FTD

BOSTON, March 13, 2024 (GLOBE NEWSWIRE) -- Cerevance, a company focused on developing precision novel therapeutics for central nervous system (CNS) diseases, today announced plans to present a poster at the upcoming Alzheimer’s Research UK Conference, taking place in Liverpool, United Kingdom, March 20-21, 2024.

Key Points: 
  • BOSTON, March 13, 2024 (GLOBE NEWSWIRE) -- Cerevance, a company focused on developing precision novel therapeutics for central nervous system (CNS) diseases, today announced plans to present a poster at the upcoming Alzheimer’s Research UK Conference, taking place in Liverpool, United Kingdom, March 20-21, 2024.
  • Overview: Cerevance’s NETSseq platform enables the identification of novel targets, such as KCNK13 (THIK1), from specific cell types in the human brain.
  • Following the discovery of KCNK13, Cerevance has developed CVN293, a novel compound that selectively inhibits KCNK13 and reduces the release of IL-1β from microglia dependent on NLRP3.
  • CVN293 shows promise in potentially addressing CNS conditions characterized by neuroinflammation, such as frontotemporal dementia (FTD), Amyotrophic lateral sclerosis (ALS), and Alzheimer’s disease.

NodThera’s NLRP3 Inhibitor NT-0796 Reverses Neuroinflammation in Parkinson’s Disease Phase Ib/IIa Trial

Retrieved on: 
Thursday, March 7, 2024
Queen Square, Doctor of Philosophy, Aes, TREM, CXCL8, CXCL1, Blood, IL-6, Cerebrospinal fluid, Inflammation, Neuroinflammation, NLRP3, Șaeș, Fibrinogen, Volunteering, Risk, Human, Biomarker, AFL, CRP, Patient, Pharmacokinetics, Disease, DSM-IV codes, MRCP, MBBS, Brain, CCL2, Mouse, Face, Pharmaceutical industry

IL-1β, IL-6, CCL2, CXCL1 and CXCL8) over 28 days compared to baseline to levels approximating those of healthy elderly controls, demonstrating reversal of NLRP3-mediated neuroinflammation.

Key Points: 
  • IL-1β, IL-6, CCL2, CXCL1 and CXCL8) over 28 days compared to baseline to levels approximating those of healthy elderly controls, demonstrating reversal of NLRP3-mediated neuroinflammation.
  • In addition, reductions in neurodegenerative markers were also observed following oral dosing of NT-0796, including NfL and soluble TREM (sTREM2).
  • The correlation between Parkinson’s disease and neuroinflammation is well-documented, with alpha-synuclein fibrils triggering microglial NLRP3 activation, leading to neuroinflammation and subsequent neurodegeneration.
  • This is the inaugural demonstration of an NLRP3 inhibitor’s potential to not only address Parkinson’s disease but also offer a broader impact on neurodegenerative diseases.

Cognition Therapeutics Presents Analyses at AD/PD™ 2024 Correlating Proteomic Findings with Treatment Effect of CT1812 in Alzheimer’s Disease Studies

Retrieved on: 
Wednesday, March 6, 2024
Alzheimer's disease, Research, Neuron, Cognition, Neuroinflammation, SPARC, Conference, Biomarker, Therapy, EEG, Protein, CSF, SHINE, Publication, Autophagy, Pharmaceutical industry

The three posters, which are listed below, summarize proteomic analyses from the completed SEQUEL and SPARC studies, which were conducted in adults with mild-to-moderate Alzheimer’s disease.

Key Points: 
  • The three posters, which are listed below, summarize proteomic analyses from the completed SEQUEL and SPARC studies, which were conducted in adults with mild-to-moderate Alzheimer’s disease.
  • These posters identify candidate protein biomarkers that correlate with improvements observed in SEQUEL participants treated with CT1812, Cognition’s lead candidate.
  • Pathways identified in these proteomic analyses support a role for CT1812 in modulating Aβ biology and neuroinflammation, among other disease-relevant processes.
  • “Analyses of CSF samples from these studies build on our efforts to identify candidate biomarkers of CT1812 treatment effect,” explained Mary Hamby, Ph.D. , VP of research at Cognition Therapeutics.

Ashvattha Therapeutics Announces First Patient Enrolled in Expanded Phase 1/2 Study of Imaging Agent 18F-OP-801 in Additional Neurological Indications

Retrieved on: 
Thursday, February 22, 2024
Therapy, Traffic barrier, PD, ALS, Inflammation, HD, Neuroinflammation, Multiple sclerosis, Safety, Biomarker, Nanomedicine, Pharmacokinetics, AMD, Patient, Clinical trial, Disease, Microglia, DME, PET, Medical imaging

The study will evaluate the safety, pharmacokinetics and biodistribution of an intravenously administered dose of 18F-OP-801 in patients with amyotrophic lateral sclerosis (ALS), Alzheimer’s disease (AD), multiple sclerosis (MS) and Parkinson’s disease (PD).

Key Points: 
  • The study will evaluate the safety, pharmacokinetics and biodistribution of an intravenously administered dose of 18F-OP-801 in patients with amyotrophic lateral sclerosis (ALS), Alzheimer’s disease (AD), multiple sclerosis (MS) and Parkinson’s disease (PD).
  • “This study builds on preclinical data which demonstrated 18F-OP-801's ability to cross the blood-brain barrier and be taken up by activated microglia in regions of neuroinflammation in multiple disease models.
  • Additional objectives include determining the correlation between PET imaging signal, biomarkers of disease activity and clinical disease assessments.
  • The study will also assess test/retest repeatability of 18F-OP-801 uptake in a subset of subjects.

Coya Therapeutics Issues Letter to Stockholders Highlighting Expansion of COYA 302 into Alzheimer’s Disease and Coya’s Pathway to a “Pipeline in a Product”

Retrieved on: 
Wednesday, February 21, 2024
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Cancer, Coya, CD4, PD, Immune system, Houston Methodist Hospital, Frontotemporal dementia, Research, LD, Inflammation, Neuroinflammation, COYA, Animal, Letter, FTD, GM-CSF, Safety, University, Biomarker, Therapy, Patient, Survival, Oxidative stress, IND, Protein aggregation, Partnership, Pharmaceutical industry

Today, we announce that we are further expanding the pipeline for COYA 302, adding Alzheimer’s disease (AD) to its growing list of indications expected to be validated in the clinic.

Key Points: 
  • Today, we announce that we are further expanding the pipeline for COYA 302, adding Alzheimer’s disease (AD) to its growing list of indications expected to be validated in the clinic.
  • Beyond COYA 302, our therapeutic platform includes additional drug product combinations using COYA 301 (our proprietary LD IL-2) as their backbone.
  • 2 investigator-initiated trial with COYA 301 in AD that we expect will support the development of COYA 302 in that same indication.
  • I look forward to providing investors with additional periodic updates on our research, clinical, corporate, and commercial progress.

Inoviv Launches NeuroKey-3™, A Quantitative Multiplexed IP-MS Assay to Measure Key Low-Level Markers in Neurodegeneration

Retrieved on: 
Friday, March 1, 2024
BDNF, Lipid, FDA, Neuroinflammation, Alzheimer's disease, NRGN, Disease, Biomarker, Protein, Clinical trial, Plasma, Dementia

NeuroKey-3™ is a proprietary method providing absolute quantification of multiple proteins in a single IP-MS assay.

Key Points: 
  • NeuroKey-3™ is a proprietary method providing absolute quantification of multiple proteins in a single IP-MS assay.
  • NeuroKey-3™ is now commercially available through Inoviv for drug developers to gather valuable data for their clinical trials.
  • LONDON, March 1, 2024 /PRNewswire/ -- Biomarker pioneer, Inoviv, announces the launch of its proprietary NeuroKey-3™ assay, an end-to-end service offering to measure key low-level markers in neurodegeneration in human plasma.
  • "NeuroKey-3 provides highly accurate and fully quantitative insights into proteins linked to neurodegeneration and can be adapted to provide definitive data into post-translational modifications, other proteins, lipids, and metabolites."