ADAS-Cog

NKGen Biotech Presents Additional Phase 1 Clinical Trial Data in Alzheimer’s Disease at the Tau2024 Global Conference

Retrieved on: 
Monday, March 25, 2024
Plasma, Conference, Tau, Cell, Disease, CSF, Patient, Biomarker, Research, Median, Asian literature, ADAS-Cog, Tau protein, Safety, NK, Amyloid, Pharmaceutical industry

SANTA ANA, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK Natural Killer (“NK”) cell therapeutics, today presented additional Phase 1 clinical trial data on the use of its investigational autologous NK cell therapy, SNK01, to treat patients with Alzheimer’s disease (“AD”) at the Tau2024 Global Conference in Washington, D.C.

Key Points: 
  • The additional Phase 1 SNK01 trial data suggest clinical activity regarding cognitive function in patients with advanced Alzheimer’s disease in addition to previously disclosed positive effects on amyloid protein and neuroinflammation biomarkers.
  • Cognitive assessments and CSF/plasma pTau217 and pTau181 analyses were performed at baseline and at 1 and 12 weeks after the final dose.
  • “The data presented today demonstrate additional beneficial effects of SNK01 for the treatment of Alzheimer’s disease,” commented Paul Y.
  • While the results were positive, the Phase 1 trial was a dose-escalation trial that only administered four total doses over 11 weeks.

Cassava Sciences Reports Full-year 2023 Financial Results and Corporate Updates

Retrieved on: 
Wednesday, February 28, 2024
Research, ARIA, FLNA, Drug development, ADAS, Exercise, ADAS-Cog, Private law, Mass spectrometry, Criterion, CDR, Bawskee 3.5, Protein, Intellectual property, Patient, Plasma, Cassava Sciences, PET, MRI, City University, Hyperkinesia, Cerebrospinal fluid, Edema, Cassava, Memory, Insulin, G&A, Tablet, Brain, City, CUNY, SAP, Calendar, Completion, Safety, Clinical, Knowledge, Alzheimer's disease, Magnetic resonance imaging, Blood, FDA, Ageing, Food, Data, Lymphocyte, Medicine, DSMB, Pharmaceutical industry

AUSTIN, Texas, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today reported financial and operating results for the full year ended December 31, 2023 and presented corporate updates.

Key Points: 
  • AUSTIN, Texas, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today reported financial and operating results for the full year ended December 31, 2023 and presented corporate updates.
  • Net cash used in operations full-year 2023 was $82.0 million, consistent with previous guidance.
  • (This amount is not included in the above cash and cash equivalents at December 31, 2023.)
  • Recent corporate highlights include the following:
    In January 2024, we completed a dividend distribution of common stock warrants to shareholders.

No Decline in Cognition Scores in Patients with Mild Alzheimer's Disease Who Received Simufilam Continuously For 24 Months

Retrieved on: 
Wednesday, February 7, 2024
FAS, Science, Clinical trial, Cassava Sciences, COVID-19, Literature, Patient, Safety, ADAS, Brain, Disease, Degenerative disease, ADAS-Cog, Data, Dementia, Alzheimer's disease, Tablet, Doctor of Philosophy, Cognition, Pharmaceutical industry

ADAS-Cog Scores Were Stable in a Group of Patients with Mild Alzheimer’s Who Received Drug Candidate Simufilam Continuously, Baseline to Month 24.

Key Points: 
  • ADAS-Cog Scores Were Stable in a Group of Patients with Mild Alzheimer’s Who Received Drug Candidate Simufilam Continuously, Baseline to Month 24.
  • Mild Alzheimer’s Patients Who Received Simufilam Non-Continuously Declined a Group Average of 1 Point on ADAS-Cog, Baseline to Month 24.
  • Average changes in ADAS-Cog scores, baseline to month 24, indicate the following:
    Patients with mild Alzheimer’s disease who received simufilam treatment continuously for two years (n=47) had no decline in ADAS-Cog scores (± 1.51 SE) as a group.
  • Patients with mild Alzheimer’s who received simufilam treatment non-continuously (n=40) declined 1 point on ADAS-Cog (± 1.65 SE) as a group.

NKGen Biotech Presented Phase I Clinical Trial Data at the 16th Annual Clinical Trials on Alzheimer’s Disease (CTAD) Conference

Retrieved on: 
Thursday, October 26, 2023
Week, Research, MRI, AD, IND, Mini–Mental State Examination, IV, Glial fibrillary acidic protein, Therapy, CSF, ADAS, Dispute board, Cell, Protein, Clinical trial, PET, Poster, ADAS-Cog, Traffic barrier, Cerebrospinal fluid, NK, Alzheimer's disease, GFAP, MMSE, Classification, Safety, Patient, Medical device, Pharmaceutical industry, Medical imaging, Hospital Angeles Tijuana

SANTA ANA, Calif., Oct. 26, 2023 (GLOBE NEWSWIRE) -- NKGen Biotech Inc. (Nasdaq: NKGN) (NKGen or the Company), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK natural killer cell therapeutics, today presented a poster with Phase I trial data on the use of its investigational NK cell therapy, SNK01, to treat patients with Alzheimer’s disease (AD) at the Clinical Trials on Alzheimer’s Disease (CTAD) Annual Meeting in Boston, MA.

Key Points: 
  • The severity of AD was based on the baseline Clinical Dementia Rating-Sum of Boxes, or CDR-SB score.
  • The primary endpoint was safety and secondary endpoints included changes in cognitive assessments and biomarker levels.
  • We are very excited to begin this next phase in hopes of establishing an entirely new treatment paradigm for more advanced patients."
  • *Data at Week 22 was only obtained for nine of the ten patients.

NeuroTherapia Presents Clinical Data from Phase 1b Clinical Trial of NTRX-07 for the Treatment of Alzheimer’s Disease

Retrieved on: 
Tuesday, October 24, 2023
Plasma, AD, Biotechnology, CNS, Clinical trial, ADAS-Cog, Neuroinflammation, EEG, Quantitative electroencephalography, Patient, Central nervous system, Pharmaceutical industry

CLEVELAND, Oct. 24, 2023 (GLOBE NEWSWIRE) -- NeuroTherapia, Inc., a clinical-stage, privately held biotechnology company developing oral, small molecule drugs to address neuroinflammatory conditions of the central nervous system (CNS), today announced the presentation of clinical data from its Phase 1b clinical trial of NTRX-07, an oral, small molecule CB2-targeting therapy in development for the treatment of Alzheimer’s disease (AD), in healthy volunteers and a subset of patients with mild cognitive impairment or early AD, at the Clinical Trials on Alzheimer’s Disease (CTAD) conference, taking place in Boston, Mass., Oct. 24-27, 2023.

Key Points: 
  • The early signs of clinical activity we observed in the AD patients included in the study were even more encouraging.
  • 32 participants, including one cohort of 8 patients with early-stage AD, received NTRX-07 or a placebo for seven days in a double-blind, randomized clinical study.
  • The safety profile of NTRX-07 supports further clinical development, with no dose-limiting or serious adverse events observed during the trial.
  • "This data gives us additional confidence that NTRX-07 could become a valuable treatment option and based on its safety profile, could be used in combination with approved antibody treatments.”

NKGen Biotech Presents Interim Phase I Trial Data at the XXVI World Congress of Neurology (WCN) Annual Meeting 2023

Retrieved on: 
Tuesday, October 17, 2023
Annual general meeting, Congress, Plasma, Cell, Therapy, Safety, PET, Montreal Cognitive Assessment, ADAS, Patient, ADAS-Cog, MMSE, CSF, Expansion, Poster, Traffic barrier, MRI, AD, Mini–Mental State Examination, NK, Neuroinflammation, WCN, XXVI, Pharmaceutical industry, Medical imaging, QC, Neurology

Severity of AD was based on the baseline Clinical Dementia Rating-Sum of Boxes, or CDR-SB score.

Key Points: 
  • Severity of AD was based on the baseline Clinical Dementia Rating-Sum of Boxes, or CDR-SB score.
  • “The results from our Alzheimer’s trial demonstrate that SNK01 has the potential to cross the blood-brain barrier as evidenced by the CSF biomarker data,” said Paul Y.
  • The pressing need for effective Alzheimer’s treatments cannot be overstated, and we are committed to addressing this healthcare challenge.
  • Based on the CSF biomarker data, intravenous SNK01 appears to cross the blood brain barrier to improve CSF AB42/40 and reduce pTau181 levels.

Coya Therapeutics (Coya) Announces Completion of Enrollment in a Well-Controlled Phase 2 Study of Low Dose Interleukin-2 (LD IL-2) in Patients with Alzheimer’s Disease (AD)

Retrieved on: 
Monday, October 9, 2023
Biotechnology, Neurology, Health, Pharmaceutical, Clinical Trials, Houston Methodist Hospital, Cerebrospinal fluid, DRS, Biomarker, LD, Coya, COYA, Safety, Neuroimaging, Bill & Melinda Gates Foundation, ADAS-Cog, SD, Therapy, MMSE, Dementia, AD, Melinda French Gates, Blood, Regulatory T cell, Patient, Pharmaceutical industry

A total of 38 patients were randomly assigned to receive subcutaneous LD IL-2 at two different dosing regimens, or matching placebo, over 21 weeks.

Key Points: 
  • A total of 38 patients were randomly assigned to receive subcutaneous LD IL-2 at two different dosing regimens, or matching placebo, over 21 weeks.
  • Coya previously reported that the treatment with LD IL-2 significantly expanded Treg population and function in an open-label proof-of concept study in 8 patients with AD.
  • Overall, administration of LD IL-2 appeared to be well tolerated in the 8 patients in the open-label, proof-of concept study.
  • No serious adverse events were reported, and no patient discontinued the study.

Coya Therapeutics Reports Additional Biomarker and Imaging Data Showing Decrease in Neuroinflammation with COYA 301 in Alzheimer's Disease

Retrieved on: 
Wednesday, June 7, 2023
SAB, Houston Methodist Hospital, Clinical Dementia Rating, Alzheimer's disease, Serum, CCL11, CCL2, Alzheimer's Association, PET, IL-6, Brain, Melinda French Gates, Biomarker, Inflammation, Dementia, Trial of the century, COYA, Cerebral cortex, Cognitive Function Scanner, ADAS-Cog, Bill & Melinda Gates Foundation, Patient, Blood, Interleukin 6, Microglia, Cytokine, Mini–Mental State Examination, Therapy, Positron emission tomography, Nerve, MMSE, ALS, Conference, Interleukin, Neuroinflammation, Pharmaceutical industry, Vaccine, Medical imaging, TSPO

- Furthermore, Coya reports a case study of a patient in the COYA 301 trial who had pre-treatment and post-treatment Positron Emission Tomography (PET) brain scans to evaluate neuroinflammation.

Key Points: 
  • - Furthermore, Coya reports a case study of a patient in the COYA 301 trial who had pre-treatment and post-treatment Positron Emission Tomography (PET) brain scans to evaluate neuroinflammation.
  • Meaningful reductions in neuroinflammation were observed throughout the cerebral cortex including hippocampal regions following treatment with COYA 301, which correlated with improvement in cognitive function in this patient.
  • The patients were treated with five day-courses of COYA 301 for four monthly cycles and were followed for two months post-treatment.
  • "We believe these additional data further support our Treg-focused approach to develop safe and effective treatments for neurodegenerative diseases of high unmet need.

Vaxxinity Announces Publication of UB-311 Safety, Tolerability, Immunogenicity, and Clinical Efficacy Data from Phase 2a Trial in Alzheimer’s Disease

Retrieved on: 
Thursday, August 10, 2023
Amyloid-related imaging abnormalities, University, Cerebral edema, Hook effect, Dementia, Reno 1868 FC, ARIA, ADAS-Cog, Patient, Observation, FDA, MMSE, Safety, Disease, Pharmaceutical industry, Vaccine

CAPE CANAVERAL, Fla., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the development of a new class of medicines, today announced the print publication of Phase 2a clinical trial data in The Lancet’s eBioMedicine (Volume 94, 104665, August 2023), stating that UB-311 “was safe and well-tolerated,” with early clinical data demonstrating a trend for slowing cognitive decline in mild Alzheimer’s disease (AD).

Key Points: 
  • UB-311 is a synthetic, peptide-based active immunotherapy that targets toxic beta-amyloid (Aβ) oligomers and fibrils and oligomers.
  • The Phase 2a data, which have been previously disclosed, describe the safety, tolerability, immunogenicity, and early clinical efficacy of UB-311 when evaluated with quarterly or biannual booster doses.
  • The gradual, natural titration of antibody titers through this approach may have contributed to a lack of ARIA-E in this study.
  • The publication titled, “Safety, tolerability, immunogenicity, and efficacy of UB-311 in participants with mild Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase 2a study,” is available online here .

NKGen Biotech Presents Interim Phase I Trial Data at 2023 Alzheimer’s Association International Conference

Retrieved on: 
Monday, July 17, 2023
Cognition, GFAP, AFL, Week, Disease, Mini–Mental State Examination, NK, Cell, Biomarker, Inflammation, ADAS-Cog, AAIC, Fluid mechanics, Magnetic resonance imaging, Protein, CSF, Poster, Alzheimer's disease, AD, Conference, Expansion, Safety, Pharmaceutical industry, Medical imaging, Patient, MMSE

Subjects received one of three doses of SNK01 (1 x 109 cells, 2 x 109 cells, or 4 x 109 cells).

Key Points: 
  • Subjects received one of three doses of SNK01 (1 x 109 cells, 2 x 109 cells, or 4 x 109 cells).
  • “We are very pleased with the interim results from our Phase I trial,” said Dr. Paul Y.
  • Based on the interim data, no related serious adverse events were observed, and a dose-limiting toxicity was not reached.
  • A SNK01 dose-response was observed, as indicated by cognitive improvement and protein and inflammation markers (CDR-SB, MMSE, pTau181, GFAP and YKL-40).