Neurotoxicity

Immix Biopharma Statement On January 2024 FDA Labeling Change Notification For Approved CAR-T Products

Retrieved on: 
Wednesday, January 24, 2024
Doctor of Philosophy, Autoimmune disease, AL amyloidosis, Patient, Amyloidosis, Neurotoxicity, MD, FDA, Pharmaceutical industry

LOS ANGELES, CA, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“Immix Biopharma”, “Company”, “We” or “Us”, Nasdaq:IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced a statement on January 2024, FDA labeling change notifications for approved CAR-T products:

Key Points: 
  • LOS ANGELES, CA, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“Immix Biopharma”, “Company”, “We” or “Us”, Nasdaq:IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced a statement on January 2024, FDA labeling change notifications for approved CAR-T products:
    “We applaud FDA’s vigilance.
  • Relapsed/refractory AL Amyloidosis remains an unmet medical need with limited treatment options.
  • In our interim clinical data to date, we have not observed any secondary T-cell malignancies,” said Ilya Rachman, MD, PhD, Immix Biopharma Chief Executive Officer.
  • Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “We believe NXC-201 will be uniquely suited to treat AL Amyloidosis and other autoimmune indications, given our interim clinical data in 73 patients to-date.”

Bristol Myers Squibb Receives Positive CHMP Opinion for CAR T Cell Therapy Abecma (idecabtagene vicleucel) in Earlier Lines of Therapy for Triple-Class Exposed Relapsed and Refractory Multiple Myeloma

Retrieved on: 
Friday, January 26, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Bristol Myers Squibb, Death, Patient, Immunomodulatory imide drug, European, CHMP, Progression-free survival, Neurotoxicity, European Medicines Agency, Cytopenia, Civil service commission, European Commission, Society, EMA, Risk, Head, Cytokine release syndrome, CRS, Multiple myeloma, Food, PFS, FDA, ASH, Committee, BMY, Pharmaceutical industry

The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.

Key Points: 
  • The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.
  • “This positive CHMP opinion represents an important step toward bringing our potentially transformative first-in-class anti-BCMA CAR T cell therapy, Abecma, to more patients earlier in the multiple myeloma treatment paradigm to improve outcomes,” said Anne Kerber, M.D., senior vice president and head, Late Clinical Development, Hematology, Oncology, Cell Therapy (HOCT), Bristol Myers Squibb.
  • Treatment with Abecma exhibited a well-established safety profile, with mostly low-grade and transient occurrences of cytokine release syndrome (CRS) and neurotoxicity.
  • In the EU, the EC delivers its final decision approximately two months following receipt of the CHMP opinion.

Fluoridation Fails to Reduce Cavities in Modern Times, Studies Show

Retrieved on: 
Tuesday, January 23, 2024
Tooth decay, EPA, American Journal, Diet, City, LOTUS, Neurotoxicity, Public, Public health, Water, Fluoride, Dentistry

Fluoridation neither reduced social inequalities in dental health, nor reduced the number of missing teeth, the researchers report.

Key Points: 
  • Fluoridation neither reduced social inequalities in dental health, nor reduced the number of missing teeth, the researchers report.
  • They write, "in high income countries, we may be reaching the limit of what can be achieved through fluorides alone."
  • Cavities are almost universal in adults exposed to fluoridated toothpaste and fluoridation from birth, they explain.
  • But none of that happened"
    A 2022 UK study of children ( CATFISH study ) reported fluoridation provided no clear benefits to 11-year-old's, and disparities persisted.

Cartesian Therapeutics Highlights Progress and 2024 Strategic Priorities Across Innovative Pipeline of mRNA Cell Therapies for Autoimmunity

Retrieved on: 
Monday, January 8, 2024
Lancet Neurology, RNA, Food, Autoantibody, Autoimmune disease, Risk, IND, Messenger, FDA, Cytokine release syndrome, The Lancet, SLE, Fatigue, Multiple myeloma, BCMA, Muscle weakness, Therapy, Pharmacokinetics, Lupus, Neurotoxicity, Transfection, Myasthenia gravis, Patient, Safety, Autoimmunity, Vaccine

The Company’s RNA-engineering approach is designed to expand the reach of cell therapy to autoimmunity with potent therapies that can be dosed more reliably and safely in an outpatient setting without lymphodepletion.

Key Points: 
  • The Company’s RNA-engineering approach is designed to expand the reach of cell therapy to autoimmunity with potent therapies that can be dosed more reliably and safely in an outpatient setting without lymphodepletion.
  • Cartesian’s proprietary technology platform, RNA Armory®, is designed to enable precision control and optimization of engineered cells for diverse cell therapies leveraging multiple modalities, including autologous, allogeneic, and in situ transfection.
  • Descartes-08 is an autologous anti-B cell maturation antigen (BCMA) mRNA CAR-T.
  • Cartesian continues to anticipate the initiation of Phase 2 basket studies in additional autoimmune indications in the second half of 2024.

Cartesian Therapeutics Announces Positive Long-Term Follow-Up Data from Phase 2a Study of Lead mRNA Cell Therapy Candidate Descartes-08 in Patients with Myasthenia Gravis

Retrieved on: 
Monday, January 8, 2024
Lancet Neurology, Patient, Quality of life, Acetylcholine receptor, Peer review, Food, Autoimmune disease, Risk, IND, Messenger, Cytokine release syndrome, The Lancet, Data, Fatigue, Lupus, BCMA, Muscle weakness, Orphan, Therapy, Clinical trial, Investigational New Drug, Quality, Pharmacokinetics, Neurotoxicity, Manuscript, Month, MedRxiv, Autoimmunity, Pharmaceutical industry

GAITHERSBURG, Md., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC), (“the Company”) a clinical-stage biotechnology company pioneering mRNA cell therapies for autoimmune diseases, today announced positive twelve-month follow-up data from its Phase 2a trial of Descartes-08 in patients with generalized myasthenia gravis (MG), a chronic autoimmune disorder that causes disabling muscle weakness and fatigue. The manuscript titled, “Twelve-Month Follow-Up of Patients With Generalized Myasthenia Gravis Receiving BCMA-Directed mRNA Cell Therapy,” has been submitted for peer-review and can be accessed on the online preprint server, medRxiv.

Key Points: 
  • The manuscript titled, “Twelve-Month Follow-Up of Patients With Generalized Myasthenia Gravis Receiving BCMA-Directed mRNA Cell Therapy,” has been submitted for peer-review and can be accessed on the online preprint server, medRxiv.
  • Descartes-08, Cartesian’s lead mRNA cell therapy candidate and a potential first-in-class mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T), is an autologous anti-B-cell maturation antigen (BCMA) mRNA CAR-T.
  • “Notably, most patients maintained robust, clinically meaningful improvements across all four standard MG severity scores approximately 10 months after the last infusion.
  • Enrollment is ongoing in a Phase 2b randomized, double-blind, placebo-controlled trial (NCT04146051) in patients with MG. Topline results are expected in mid-2024.

Alzheon CEO Dr. Martin Tolar to Present ALZ-801/Valiltramiprosate Investigational Oral Alzheimer’s Treatment Program at Nobel Forum at Karolinska Institute in Stockholm, Sweden

Retrieved on: 
Wednesday, January 3, 2024
Science, Neurology, Other Science, Biotechnology, Research, Pharmaceutical, Health, Clinical Trials, Karolinska Institute, Cognition, Cerebrospinal fluid, Implementation, Risk, Cerebral edema, MD, Doctor of Philosophy, Nerve, Early, Neurotoxicity, Amyloid, Patient, Safety, Therapy, Pharmaceutical industry

Alzheon Founder, President, and CEO, Martin Tolar, MD, PhD, will present an overview of investigational oral ALZ-801/valiltramiprosate anti-amyloid oligomer treatment program in the section “Optimal Treatment for Future – Combination Therapy?” moderated by Kaj Blennow, MD, PhD, on January 19 at 1:30 PM CET (7:30 AM EST).

Key Points: 
  • Alzheon Founder, President, and CEO, Martin Tolar, MD, PhD, will present an overview of investigational oral ALZ-801/valiltramiprosate anti-amyloid oligomer treatment program in the section “Optimal Treatment for Future – Combination Therapy?” moderated by Kaj Blennow, MD, PhD, on January 19 at 1:30 PM CET (7:30 AM EST).
  • “We are honored to have received an invitation to present at the prestigious Nobel Forum and discuss how ALZ-801 tablet could help shape the future therapeutic landscape for Alzheimer’s disease.
  • Alzheon's simplified approach with an oral tablet has an opportunity to transform the standard of care for millions of patients,” said Martin Tolar, MD, PhD, Founder, President, and CEO of Alzheon.
  • “ALZ-801 efficacy data and a favorable safety profile, showing no increased risk of vasogenic edema, underscore the differentiated clinical profile of the treatment.

Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
People, Marketing, INN, Risk, Leukopenia, Hypophosphatemia, Hypotension, Pneumonia, Potassium, Nausea, Cancer, Myenteric plexus, Infection, Anatomy, Cough, IIA, Multiple myeloma, Chills, Consciousness, Diarrhea, Fever, Fatigue, Bone marrow, ATC, Pharyngitis, Pain, Platelet, Disease, Nose, Edema, Neutrophil, Speech, Depression, Appetite, Writing, Lymphocyte, Safety, Water, Tachycardia, Anemia, Neurological disorder, Hypocalcemia, Sepsis, Hypokalemia, Patient, Medical Subject Headings, Febrile neutropenia, Lymphocytopenia, Cytokine release syndrome, International, Encephalopathy, Neutropenia, Blood, Language, Thrombocytopenia, Neurotoxicity, Select, Medicine, Vomiting, Upper respiratory tract infection, Headache, Hospital, BCMA, Confusion, European Medicines Agency, Cell, Medical device

Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

AC Immune’s Targeted Anti-pTau Active Immunotherapy for Alzheimer’s Disease Advances into Phase 2b Trial

Retrieved on: 
Friday, December 15, 2023
Partnership, AC, Deficit spending, Johnson & Johnson, Janssen Pharmaceuticals, Function (mathematics), Biomarker, FDA, Janssen, Injection, Biologics license application, Clinical trial, CHF, Dementia, JAMA, Pathology, Neurotoxicity, Patient, MCI, Memory, Tauopathy, BLA, Vaccine

ACI-35.030 is an investigational targeted active immunotherapy, selective for pathological phosphorylated Tau (pTau).

Key Points: 
  • ACI-35.030 is an investigational targeted active immunotherapy, selective for pathological phosphorylated Tau (pTau).
  • Studies have shown that pTau correlates with AD progression and the trial aims to show that ACI-35.030 can prevent or slow down the progression of tau pathology and onset of clinical symptoms.
  • The partnership with Janssen aims to develop and commercialize therapeutic anti-Tau active immunotherapies for the treatment of AD and potentially other Tauopathies.
  • It is sensitive enough to detect early changes in cognitive function, even before the first clinical signs of mild cognitive impairment (MCI) are apparent2.

Gracell Biotechnologies Presents Updated Clinical Data from FasTCAR-T GC012F Demonstrating Deep and Durable Responses in Newly Diagnosed Multiple Myeloma at ASH 2023

Retrieved on: 
Tuesday, December 12, 2023
Autoimmune disease, Plasmacytoma, Cytokine release syndrome, Grade 2, International, Data, IIT, Multiple myeloma, SAN, Society, Cancer, SCR, ASH, Neurotoxicity, CRS, Patient, Safety, PFS, Pharmaceutical industry

SAN DIEGO and SUZHOU, China and SHANGHAI, China, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today presented updated results from the clinical investigator-initiated trial (IIT) of GC012F for treatment of newly diagnosed multiple myeloma (NDMM) as an oral presentation at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition taking place in San Diego, California and online.

Key Points: 
  • GC012F demonstrated a 100% overall response rate (ORR) and 95% MRD- sCR rate among 22 transplant-eligible, high-risk NDMM patients as of the data cutoff date of October 1, 2023.
  • The data included longer-term follow-up from the initial 16 patients, for whom earlier results were presented at the 2022 American Society for Hematology (ASH) Annual Meeting, plus six additional patients that were enrolled and treated later.
  • The data also showed that GC012F was well-tolerated with no new safety signals observed in this frontline application of CAR-T therapy.
  • “We are delighted to announce the updated data of FasTCAR-T GC012F for the treatment of multiple myeloma patients in the frontline setting.

Marker Therapeutics Announces Sustained Complete Response in First Lymphoma Patient Treated with MT-601 following CAR T Relapse

Retrieved on: 
Monday, December 11, 2023
Risk, Principal, DLBCL, FDA, City, Therapy, Press release, B-cell lymphoma, Neurotoxicity, Mutagenesis, Chong, Patient, Lymphoma, Bone marrow, Food and Drug Administration, APOLLO, Pharmaceutical industry

The patient had diffuse large B cell lymphoma (DLBCL) and failed four prior lines of therapy, including anti-CD19 CAR T cell therapy.

Key Points: 
  • The patient had diffuse large B cell lymphoma (DLBCL) and failed four prior lines of therapy, including anti-CD19 CAR T cell therapy.
  • Marker reports today that six months following the initial treatment with MT-601 the study participant has maintained complete response to treatment.
  • “Relapse rates following CAR T cell therapy are high,” said Juan F. Vera, M.D., President and Chief Executive Officer of Marker Therapeutics.
  • “The ongoing complete response observed after MT-601 infusion in a CAR relapsed patient with lymphoma suggests superior durability of our therapy over CAR T cells in this patient.