Neurotoxicity

Athira Pharma Presents New Clinical and Preclinical Data at the American Academy of Neurology (AAN) 2023 Annual Meeting

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Tuesday, April 25, 2023
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BOTHELL, Wash., April 25, 2023 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced the presentation of new data from its small molecule programs enhancing the HGF/MET neurotrophic system. The data were presented in oral and poster presentations at the American Academy of Neurology (AAN) 2023 Annual Meeting taking place from April 22-27, 2023, in person in Boston, Mass. and virtually.

Key Points: 
  • The data were presented in oral and poster presentations at the American Academy of Neurology (AAN) 2023 Annual Meeting taking place from April 22-27, 2023, in person in Boston, Mass.
  • “These and other data presented at this year’s AAN Annual Meeting further support other previously reported post hoc findings from ACT-AD that showed improvements in plasma biomarkers and measures of cognition.
  • Additionally, we reported new data that further elucidate the interaction between fosgonimeton and AChEIs.
  • The information presented in this press release is solely the responsibility of Athira and does not necessarily represent the official views of the National Institutes of Health.

Wren Therapeutics Renamed WaveBreak, Signifying Focus on Stopping the Wave of Neurodegeneration in Parkinson's Disease,Alzheimer's Disease, and ALS at its Source

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Tuesday, April 25, 2023
Drug discovery, Protein, Protein folding, Therapy, Parkinson's disease, ALS, Neurotoxicity, Alzheimer's disease, Pharmaceutical industry

BOSTON, April 25, 2023 /PRNewswire/ -- Wren Therapeutics announced today that the company has changed its name to WaveBreak.

Key Points: 
  • BOSTON, April 25, 2023 /PRNewswire/ -- Wren Therapeutics announced today that the company has changed its name to WaveBreak.
  • This new name reflects the company's focus on developing small-molecule therapeutics that inhibit the production of fleeting protein intermediates—the oligomers—that are at the source of the protein misfolding and aggregation assembly pathways in the major neurodegenerative diseases.
  • WaveBreak's technology platform enables analysis of the inhibition of the source mechanisms that produce oligomer intermediates in complex disease processes.
  • It is a network-centric approach to enable the discovery of small molecules that can block their generation with specificity and precision.

Medigene AG presents final Phase I data of TCR-T cell therapy MDG1011 in patients with high-risk blood cancers

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Monday, April 24, 2023
Myelodysplastic syndrome, EBMT, Blood, CRS, DL, Preferential hyperacuity perimetry, Neurotoxicity, Multiple myeloma, Aes, Clinical trial, Bone marrow, Pharmacokinetics, IL-6, FSE, DL2, MDS/MPN, TCR, Acute myeloid leukemia, MDS, AML, Lymphoid neoplasms with plasmablastic differentiation, HIV disease progression rates, Cytokine release syndrome, Patient, MM, Antigen, Poster, Leukapheresis, European Society for Medical Oncology, MPN, P227, Disease, Human, Pharmaceutical industry, Vaccine, PB, PRAME, Melanoma

Medigene AG (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, today reports final Phase I dose escalation results from first-in-human Study of HLA-A*02:01-restricted PRAME-specific T cell receptor engineered T cell (TCR-T) therapy (MDG1011) for high-risk myeloid and lymphoid neoplasms ( NCT03503968 ).

Key Points: 
  • Medigene AG (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, today reports final Phase I dose escalation results from first-in-human Study of HLA-A*02:01-restricted PRAME-specific T cell receptor engineered T cell (TCR-T) therapy (MDG1011) for high-risk myeloid and lymphoid neoplasms ( NCT03503968 ).
  • Subsequently, nine patients with relapsed or refractory AML, MDS/MPN or MM received MDG1011 by single intravenous infusion after a lymphodepleting regimen.
  • Patients received MDG1011 at one of three escalating dose levels (DL): 0.1 (DL1), 1.0 (DL2) or 5.0 (DL3) million TCR-transduced T cells per kg body weight.
  • Immune monitoring of patients included quantification of PRAME levels in bone marrow (BM) and/or peripheral blood (PB) and pharmacokinetics of MDG1011 in PB.

Alzheon to Present Baseline Imaging Characteristics from Ongoing APOLLOE4 Phase 3 Trial of Oral Tablet ALZ-801 (Valiltramiprosate) and Results of Phase 2 Biomarker Study at American Academy of Neurology Conference in Boston

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Tuesday, April 18, 2023
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ALZ-801 (valiltramiprosate) is an investigational oral disease-modifying therapy in Phase 3 development for the treatment of early AD.

Key Points: 
  • ALZ-801 (valiltramiprosate) is an investigational oral disease-modifying therapy in Phase 3 development for the treatment of early AD.
  • In mechanism-of-action studies, ALZ-801 fully blocked the formation of neurotoxic soluble beta amyloid (Aβ) oligomers at the Phase 3 clinical dose.
  • This population is the focus of Alzheon’s pivotal Phase 3 APOLLOE4 trial , which is now fully enrolled and will be completed in mid-2024.
  • We look forward to communicating the final 24-month data from our Phase 2 study later in 2023.”

mHealth Startup NeurCare Named as an Awardee in the Improving Detection of Neurotoxicity in Immunotherapies QuickFire Challenge

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Monday, April 17, 2023
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LOS ANGELES, April 17, 2023 /PRNewswire-PRWeb/ -- NeurCare, an mHealth startup incubated by Dogtown Media, has been selected as an awardee of the Improving Detection of Neurotoxicity in Immunotherapies QuickFire Challenge launched by Johnson & Johnson Innovation LLC. This QuickFire Challenge was launched to inspire early identification of neurotoxicity in patients undergoing immunotherapies for hematologic malignancies. The onset of neurotoxicity can vary widely and have a highly variable course. Early detection of acute toxicities is critical to enable timely interventions and improved outcomes for patients.

Key Points: 
  • NeurCare, an mHealth startup incubated by Dogtown Media, has been selected as an awardee in the Improving Detection of Neurotoxicity in Immunotherapies QuickFire Challenge.
  • The NeurCare app is designed to remotely monitor patients with neurological disorders and detect neurotoxicity in patients undergoing immunotherapies for hematologic malignancies.
  • LOS ANGELES, April 17, 2023 /PRNewswire-PRWeb/ -- NeurCare, an mHealth startup incubated by Dogtown Media, has been selected as an awardee of the Improving Detection of Neurotoxicity in Immunotherapies QuickFire Challenge launched by Johnson & Johnson Innovation LLC.
  • This QuickFire Challenge was launched to inspire early identification of neurotoxicity in patients undergoing immunotherapies for hematologic malignancies.

Gain Therapeutics to Present Positive Preclinical Data on its GBA1 Program at the AD/PD 2023 Meeting

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Wednesday, March 29, 2023
Molecule, Gaucher's disease, Neuron, GBA1, STAR, Neurodegenerative disease, DSM-IV codes, Deficit spending, Toxicity, Disorder, Tauopathy, Star, International Conference on Emerging Infectious Diseases, Alzheimer's disease, Poster, AD, Glucocerebrosidase, SVP, Therapy, Conference, Neurotoxicity, Pharmaceutical industry, Medical device

The data will be shown in a poster presentation at the 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD) being held March 28 – April 1, 2023 in Gothenburg, Sweden.

Key Points: 
  • The data will be shown in a poster presentation at the 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD) being held March 28 – April 1, 2023 in Gothenburg, Sweden.
  • “We are pleased to expand upon the extensive package of preclinical data generated with our STAR compounds, which continue to demonstrate their potential advantages across a range of disorders associated with GCase protein misfolding,” said Matthias Alder, Chief Executive Officer.
  • “We have shown previously that STAR-mediated augmentation of lysosomal GCase induces a neuroprotective effect in cellular and in vivo models of GBA1 Parkinson’s disease and Gaucher disease.
  • The data therefore demonstrate that structurally targeted allosteric regulators are a potential disease-modifying, novel pharmacological option for the treatment of AD and other tauopathies that warrants further investigation.

Alzheon to Present Biomarker, Brain Preservation and Clinical Effects of Oral Tablet ALZ-801 (Valiltramiprosate) at Upcoming AD/PD 2023 Conference in Gothenburg, Sweden

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Wednesday, March 22, 2023
Biotechnology, Health, General Health, Pharmaceutical, Biometrics, Neurology, Mental Health, Other Science, Research, Science, Clinical Trials, Genotype, CET, Czech Republic, Organic chemistry, Pathology, EST, COVID, Biomarker, Doctor of Philosophy, Dementia, Plasma, Oligomer, Amyloid, MD, Patient, Risk, Medicine, Drug development, Oral, CSF, Poster, Detection, AD, HV, MMSE, Safety, Conference, Neurotoxicity, Institute of Organic Chemistry and Biochemistry, Pharmaceutical industry, Biochemistry, Alzheon

In mechanism of action studies, ALZ-801 fully inhibited the formation of amyloid oligomers at the Phase 3 clinical dose.

Key Points: 
  • In mechanism of action studies, ALZ-801 fully inhibited the formation of amyloid oligomers at the Phase 3 clinical dose.
  • This population is the focus of Alzheon’s pivotal Phase 3 APOLLOE4 trial and has the highest likelihood of demonstrating successful efficacy outcomes.
  • “Preventing oligomer formation with an oral tablet is a simplified approach to disease modification in Alzheimer’s.
  • Mikuláš Vlk of IOCB will present the poster, with Dr. Hey and other Alzheon scientists among contributing authors.

MiNK Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results

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Tuesday, March 21, 2023
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NEW YORK, March 21, 2023 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today reported financial results for the fourth quarter and full year 2022.

Key Points: 
  • NEW YORK, March 21, 2023 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today reported financial results for the fourth quarter and full year 2022.
  • Fourth Quarter and Full Year 2022 Business Highlights:
    MiNK's focus is on advancing the clinical and preclinical programs of their iNKT cell pipeline, as well as expanding their in-house manufacturing capabilities.
  • MiNK is FDA cleared for fully in-house cGMP manufacturing of allogeneic iNKT cells, with a process designed to achieve > 5,000 doses per batch.
  • Cash used in operations for the year and fourth quarter ended December 31, 2022, was $18.9 million, and $4.4 million respectively, compared to $12.8 million and $1.7 million for the same periods in 2021.

Nkarta Reports Fourth Quarter and Full Year 2022 Financial Results and Corporate Highlights

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Thursday, March 16, 2023
Cancer, CD70, CRISPR, Graft-versus-host disease, AACR, Society, Therapy, MRD, Multiple myeloma, CR, D, Patient, Cash, R, American Association for Cancer Research, Neurotoxicity, SAN, Neoplasm, MDS, Infection, Antibody, CAR, Acute myeloid leukemia, ADCC, Mab, Tenant, SITC, Toxicity, CRISPR Therapeutics, Aplastic anemia, CD19, Investment, Research, Grade 3, Society for Immunotherapy of Cancer, G&A, CRS, Safety, Clinical trial, Immunotherapy, AML, NKG2D, NK, Toxic epidermal necrolysis, Pharmaceutical industry, Vaccine

R&D Expenses: Research and development (R&D) expenses were $90.9 million for the full year 2022 and $26.8 million for the fourth quarter of 2022.

Key Points: 
  • R&D Expenses: Research and development (R&D) expenses were $90.9 million for the full year 2022 and $26.8 million for the fourth quarter of 2022.
  • Non-cash stock-based compensation expense included in R&D expense was $7.3 million for the full year 2022 and $1.9 million for the fourth quarter of 2022.
  • G&A Expenses: General and administrative (G&A) expenses were $28.1 million for the full year 2022 and $8.1 million for the fourth quarter of 2022.
  • Net loss was $32.6 million, or $0.67 per basic and diluted share, for the fourth quarter of 2022.

AC Immune Reports Full Year 2022 Financial Results and Provides Corporate Update

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Thursday, March 16, 2023
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PI-2620 was discovered and developed using the Morphomer® platform as part of a research collaboration between AC Immune and LMI.

Key Points: 
  • PI-2620 was discovered and developed using the Morphomer® platform as part of a research collaboration between AC Immune and LMI.
  • Snow previously held the title of Associate Vice President, Financial Reporting and prior to joining AC Immune worked as a manager at BDO.
  • G&A Expenditures: G&A expenses decreased by CHF 2.1 million for the year ended December 31, 2022 to CHF 15.8 million.
  • AC Immune anticipates that its total cash burn will be in the range of CHF 65 to CHF 75 million for the full year 2023.