Lupus nephritis

Adicet Bio Receives FDA Fast Track Designation for ADI-001 in Lupus Nephritis

Retrieved on: 
onsdag, juni 5, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Food, Fast track (FDA), Conditional sentence, Trial of the century, Cancer, Lupus nephritis, Pharmaceutical industry

Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV lupus nephritis.

Key Points: 
  • Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV lupus nephritis.
  • “The FDA’s decision to grant ADI-001 Fast Track Designation for lupus nephritis underscores the urgent need for new therapies for this chronic disease,” said Chen Schor, President and Chief Executive Officer of Adicet Bio.
  • “We plan to initiate our Phase 1 clinical study in lupus nephritis later this month.
  • With clinical data for ADI-001 in non-Hodgkin’s lymphoma demonstrating CD19+ B-cell depletion that mirrors data by autologous alpha-beta CAR T in academic clinical studies in several autoimmune diseases, we believe we are well positioned to expand our autoimmune program to address additional indications beyond lupus nephritis.

Atara Biotherapeutics Presents Preclinical Data on ATA3219, an Allogeneic CD19-Targeted CAR T Therapy for the Treatment of B-Cell Driven Autoimmune Diseases, at the ISCT 2024 Annual Meeting

Retrieved on: 
onsdag, maj 29, 2024
Research, Clinical Trials, Stem Cells, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, EBV, Patient, Cell, Epstein–Barr virus, Phenotype, ISCT, Toxicity, SLE, Cytokine, CD19, International Society, ATRA, Cancer, Autoimmunity, PDT, IL-6, NHL, Inflammation, Lupus nephritis, Annual general meeting, Vaccine

Findings demonstrate that ATA3219 maintains comparable cytotoxic function and potency while inducing lower levels of pro-inflammatory cytokines compared to autologous benchmark CD19 CAR T cells.

Key Points: 
  • Findings demonstrate that ATA3219 maintains comparable cytotoxic function and potency while inducing lower levels of pro-inflammatory cytokines compared to autologous benchmark CD19 CAR T cells.
  • The data will be presented in a poster session at the International Society for Cell & Gene Therapy (ISCT) 2024 Annual Meeting taking place May 29 to June 1, 2024, in Vancouver, Canada.
  • ATA3219 consists of allogeneic CD19-directed CAR EBV T cells that have been optimized to offer a potential best-in-class profile and off-the-shelf availability.
  • “We are pleased to share promising preclinical data that shows ATA3219 mediates robust B-cell depletion against SLE and multiple sclerosis patient derived immune cells.

GRI Bio Presents Positive Preclinical Data from Pipeline of NKT Cell Modulators in Development for the Treatment of Systemic Lupus Erythematosus (SLE)

Retrieved on: 
tisdag, maj 21, 2024
Patient, Phenotype, Doctor of Philosophy, Science, SLE, Immune system, IND, Autoimmune disease, Congress, Natural killer T cell, T2B, CGMP, GRI, NKT, Lupus nephritis, Vaccine

LA JOLLA, CA, May 21, 2024 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio,” “we,” “our,” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (NKT) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced Vipin Kumar Chaturvedi, PhD, Chief Scientific Officer of GRI Bio presented encouraging preclinical data from the Company’s preclinical studies of type 2 NKT activating molecules, GRI-0803 and GRI-0124 at the 14th International Congress on Autoimmunity held May 17-20, 2024 in Ljubljana, Slovenia (the Congress).

Key Points: 
  • GRI Bio’s second asset in development, GRI-0803, is a novel activator of human type 2 NKT cells.
  • Activation of type 2 NKT leads to a dendritic cell-mediated inhibition of type 1 invariant NKT (iNKT) cells.
  • In the Company’s preclinical studies, type 2 NKT activating molecules, GRI-0803 and GRI-0124, were observed to inhibit both murine and human iNKT cells.
  • Oral administration of these type 2 NKT activating molecules was observed to inhibit lupus nephritis and to significantly improve overall survival.

Fc and Glycoengineered Antibodies Research 2024-2035: Close to 250 Trials are Evaluating Fc and Glycoengineered Antibodies to Treat Myriad of Disease Indications - ResearchAndMarkets.com

Retrieved on: 
torsdag, maj 23, 2024
Biotechnology, Pharmaceutical, Health, Half-life, Patient, ADCC, COVID-19, Myasthenia gravis, ADCP, Kyowa Kirin, Pfizer, Type, USD, Amgen, Chronic lymphocytic leukemia, Bladder cancer, Investment, Prevalence, Clinical trial, Lung cancer, Atypical hemolytic uremic syndrome, Disease, Asthma, Breast cancer, Boehringer Ingelheim, Database, Administration, Research, Growth, Multiple myeloma, Hub, AbbVie, CDC, AstraZeneca, Antibody, Lupus nephritis, Vaccine

The new research study consists of industry trends, detailed Fc and glycoengineered antibodies market analysis, key market insights, market impact analysis, market forecast and opportunity analysis.

Key Points: 
  • The new research study consists of industry trends, detailed Fc and glycoengineered antibodies market analysis, key market insights, market impact analysis, market forecast and opportunity analysis.
  • Currently, several drug developers, along with technology providers in this domain, are actively developing various Fc and glycoengineered antibodies.
  • Around 250 clinical trials have been registered across different geographical regions in order to evaluate various Fc and glycoengineered antibodies.
  • This market report includes an easily searchable excel database of all the companies that have the capability to offer Fc and glycoengineered antibodies.

iCell Gene Therapeutics Announces Positive Clinical Data from Investigator Initiated Phase 1 Trial Evaluating BCMA-CD19 Compound CAR in Patients with Systemic Lupus Erythematosus/Lupus Nephritis Published in Annals of the Rheumatic Diseases

Retrieved on: 
torsdag, maj 23, 2024
Biotechnology, Health, Genetics, Pharmaceutical, Clinical Trials, European Alliance, Patient, Survival, Lupus, CCAR, Data, Infection, IIT, COVID-19, Class, Patent, T cell, SLE, Clinical trial, CD19, Immunoglobulin M, IND, Safety, Urinary tract infection, Autoantibody, MFR, Cancer, Autoimmunity, Cyclophosphamide, Hospital, EULAR, B cell, BCMA, Glucocorticoid, Canadian Aviation Regulations, LN, Lupus nephritis, CRS, Pharmaceutical industry

The clinical trial evaluated the safety and efficacy of a complete humoral reset of both long-lived plasma cells and B cells in 13 systemic lupus erythematosus (SLE) patients treated with iCell’s cCAR, including 11 patients with SLE and lupus nephritis (LN).

Key Points: 
  • The clinical trial evaluated the safety and efficacy of a complete humoral reset of both long-lived plasma cells and B cells in 13 systemic lupus erythematosus (SLE) patients treated with iCell’s cCAR, including 11 patients with SLE and lupus nephritis (LN).
  • These patients achieved symptom-free and medication-free remission (MFR), with post-cCAR follow-up to 46 months.
  • There are currently no approved therapies that deliver MFR in SLE/LN patients who are at high risk of long-term organ damage and kidney transplant.
  • The data suggest that cCAR therapy was safe and effective in inducing MFR and depleting disease-causing autoantibodies in SLE and LN patients.

Adicet Reports First Quarter 2024 Financial Results and Provides Business Updates

Retrieved on: 
tisdag, maj 14, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Patient, Mantle cell lymphoma, Holocene, Renal cell carcinoma, MCL, FDA, Safety, Protocol, Cancer, NHL, Research and development, Administration, Bone marrow, Lupus nephritis, Pharmaceutical industry

The Company plans to commence a Phase 1 clinical trial to assess the safety and efficacy of ADI-001 in lupus nephritis in the second quarter of 2024.

Key Points: 
  • The Company plans to commence a Phase 1 clinical trial to assess the safety and efficacy of ADI-001 in lupus nephritis in the second quarter of 2024.
  • Preliminary data from the study are anticipated during the fourth quarter of 2024 or first quarter of 2025, depending on patient enrollment and study site activation.
  • Based on ADI-270’s promising profile in preclinical studies to date, Adicet expects to submit an IND for ADI-270 in renal cell carcinoma in the second quarter of 2024.
  • Financial Results for First Quarter 2024:
    Research and Development (R&D) Expenses: R&D expenses were $23.9 million for the three months ended March 31, 2024, compared to $26.8 million during the same period in 2023.

Analysis Showing LUPKYNIS® is a Cost-Effective Treatment for Lupus Nephritis Presented at National Kidney Foundation’s Spring Clinical Meeting 2024

Retrieved on: 
tisdag, maj 14, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Blood pressure, Diabetes, Patient, Steroid, Hyperlipidemia, Kidney disease, ICER, National Kidney Foundation, Disease, QALY, Glucocorticoid, Cyclophosphamide, MMF, Safety, Physician, Proteinuria, Lupus nephritis, CNI, NKF, Pharmaceutical industry

Economic modeling by the Institute for Clinical and Economic Review (ICER) in March 2021 demonstrated the cost-effectiveness of LUPKYNIS in adults with active lupus nephritis (LN).

Key Points: 
  • Economic modeling by the Institute for Clinical and Economic Review (ICER) in March 2021 demonstrated the cost-effectiveness of LUPKYNIS in adults with active lupus nephritis (LN).
  • An updated cost-effectiveness analysis demonstrated that LUPKYNIS continues to be a cost-effective treatment for lupus nephritis (LN).
  • Cost-effectiveness was assessed with the ICER AnalyticsTM LN model and the majority of model assumptions from the original analysis were consistent with the 2021 analysis.
  • “People living with lupus nephritis must be able to access clinically meaningful treatment options to manage the severity of the disease.

Equillium Reports First Quarter 2024 Financial Results and Provides Recent Clinical Highlights

Retrieved on: 
torsdag, maj 9, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Investment, Lupus nephritis, Alopecia areata, Partnership, Trial of the century, Exercise, Therapy, Patient, Chemistry, CMC, Itolizumab, Inc., G&A, Pharmaceutical industry

Equillium Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced financial results for the first quarter 2024 and highlights in clinical development.

Key Points: 
  • Equillium Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced financial results for the first quarter 2024 and highlights in clinical development.
  • Revenue for the first quarter of 2024 was $10.7 million, compared to $8.9 million during the same period in 2023.
  • Research and development (R&D) expenses for the first quarter of 2024 were $9.7 million, compared to $9.3 million for the same period in 2023.
  • General and administrative expenses for the first quarter of 2024 remained relatively constant compared to the same period in 2023.

Nkarta Reports First Quarter 2024 Financial Results and Corporate Highlights

Retrieved on: 
torsdag, maj 9, 2024
NK, Investment, Lupus nephritis, Safety, Research, Cy, B cell, IND, Autoimmune disease, CD19, Cyclophosphamide, Patient, Cytopenia, NHL, SLE, Lymphoid leukemia, G&A, Investigational New Drug, Pharmaceutical industry

Nkarta expects to provide an update on first patient dosing for NKX019 in LN in the first half of 2024.

Key Points: 
  • Nkarta expects to provide an update on first patient dosing for NKX019 in LN in the first half of 2024.
  • In March 2024, Nkarta completed an underwritten offering of common stock and pre-funded warrants with gross proceeds of $240.1 million.
  • Nkarta had cash, cash equivalents, restricted cash, and investments in marketable securities of $450.0 million as of March 31, 2024.
  • Net loss was $29.5 million, or $0.58 per basic and diluted share, for the first quarter of 2024.

argenx Reports First Quarter 2024 Financial Results and Provides Business Update

Retrieved on: 
torsdag, maj 9, 2024
MuSK protein, FDA, ARDA, IND, PDUFA, Medicine, Autoimmunity, Efgartigimod alfa, Glomerulonephritis, CMS, Inflammation, ITP, IIP, ALS, Alfa Romeo, C2, Therapy, Systemic scleroderma, Safety, Euronext, Nektar, DGF, Sjögren syndrome, CIDP, Biology, IL-6, Nektar Therapeutics, GMG, TED, File, MMN, Lupus nephritis, Kidney, AMR, Multifocal motor neuropathy, Patient, Congenital myasthenic syndrome, Immune system, Dermatomyositis, Growth, Amgen, Pharmaceutical industry

“The team at argenx has made significant progress executing across the ambitious plan we set out at the beginning of the year,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

Key Points: 
  • “The team at argenx has made significant progress executing across the ambitious plan we set out at the beginning of the year,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
  • “We are driven by our commitment to provide patients with the broadest gMG product offering that consistently delivers on safety and efficacy.
  • VYVGART SC played a key role in our growth over the quarter, expanding the breadth of our prescriber base and reaching new patients.
  • In addition, argenx is evaluating ARGX-119, a muscle-specific kinase (MuSK) agonist in both congenital myasthenic syndrome (CMS) and amyotrophic lateral sclerosis (ALS).