Lupus nephritis

Caribou Biosciences Expands Clinical Development of CB-010 with FDA Clearance of IND in Lupus

Retrieved on: 
Thursday, April 4, 2024
Logic, LN, Transplant, Medical College of Wisconsin, Rachel Haurwitz, Infection, Lupus, Risk, Medical college, Patient, Inflammation, Tissue, Autoimmune disease, Standard of care, Doctor of Philosophy, MD, Autoantibody, IND, Congress, HLA, Reindeer, Antibody, CRISPR, Safety, Immune system, Fatigue, FDA, Lupus nephritis, Autoimmunity, Bone marrow, ERL, Medicine, CD19, Food, PD-1, Pharmaceutical industry

BERKELEY, Calif., April 04, 2024 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced that it received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout (KO), for the treatment of lupus nephritis (LN) and extrarenal lupus (ERL). The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024.

Key Points: 
  • The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024.
  • CB-010 targets CD19, a protein on the surface of B cells, and has a PD-1 knockout (KO) that reduces CAR-T cell exhaustion.
  • CB-010 holds the potential for deep depletion of disease-causing B cells which could reset the immune system, leading to sustained drug-free remission.
  • Instead, the chRDNA technology allows for precise insertion of the CAR at an intended location within the T cell genome.

GRI Bio Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, April 1, 2024
Research, Conference, Lupus, Inflammation, Patient, Food and Drug Administration, CTA, Doctor of Philosophy, SLE, Insurance, GRI, IPF, Fibrosis, Oxygen, Immune system, Injury, NKT, Food, Movement, Lupus nephritis, Autoimmune disease, Natural killer T cell, Medication, Pharmaceutical industry

LA JOLLA, CA, April 01, 2024 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” 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 reported its financial results for the fiscal year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream.
  • GRI Bio’s lead program, GRI-0621, is a small molecule RAR-βɣ dual agonist that inhibits the activity of human iNKT cells.
  • Research and development expenses were $3.2 million and $0.2 million for the years ended December 31, 2023 and 2022, respectively.
  • General and administrative expenses were $8.2 million and $2.0 million for the years ended December 31, 2023 and 2022, respectively.

Equillium Announces Positive Topline Data from the Type B Portion of the Phase 1b EQUALISE Study of Itolizumab in Lupus Nephritis

Retrieved on: 
Monday, April 1, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, EOS, Itolizumab, Week, S1P, Dialysis, Type, AMP, Exercise, Ono Pharmaceutical, Infection, Lymphocytopenia, Patient, Serum albumin, Peripheral edema, CD6, Lupus, EULAR, EGFR, Therapy, Proteinuria, ALC, Lupus nephritis, Nursing

Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced positive topline data from the Type B portion of the Phase 1b EQUALISE study evaluating itolizumab in lupus nephritis patients.

Key Points: 
  • Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced positive topline data from the Type B portion of the Phase 1b EQUALISE study evaluating itolizumab in lupus nephritis patients.
  • Key topline data from the Type B portion of the EQUALISE study in lupus nephritis:
    Subjects were highly proteinuric: baseline mean UPCR of 4.9 g/g.
  • Itolizumab treatment (over 6 months) was also associated with reductions in absolute lymphocyte counts (ALC), another known pharmacodynamic effect.
  • Two subjects had at least one serious adverse event, none of which were related to study treatment.

Atara Biotherapeutics Announces Fourth Quarter and Full Year 2023 Financial Results and Operational Progress

Retrieved on: 
Thursday, March 28, 2024
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, The Lancet, Research, Graft-versus-host disease, LD, ASH, International Society, Partnership, Central nervous system, ATRA, Epstein–Barr virus, Patient, Follicular lymphoma, CNS, Biomarker, PTLD, Cancer, Lymphoproliferative disorders, SLE, EBV, NHL, Lymphoma, Mantle cell lymphoma, Investment, ATM, Safety, Pharmacokinetics, Depreciation, File, Workforce, Cell, FDA, BLA, Lupus nephritis, CD19, Food, Autoimmune disease, Pharmaceutical industry

“We are expanding Atara’s proven EBV T-cell platform into allogeneic CAR T therapy for both oncology and autoimmune disease,” said Pascal Touchon, President and Chief Executive Officer of Atara.

Key Points: 
  • “We are expanding Atara’s proven EBV T-cell platform into allogeneic CAR T therapy for both oncology and autoimmune disease,” said Pascal Touchon, President and Chief Executive Officer of Atara.
  • “This includes strong momentum for our lead CAR T program, ATA3219, which is positioned to deliver near-term clinical data for both non-Hodgkin’s lymphoma and lupus nephritis.
  • Subjects will receive lymphodepletion (LD) treatment followed by ATA3219 at a dose of 40, 80, or 160 x 106 CAR+ T cells.
  • Subjects will receive LD treatment followed by ATA3219 at a dose of 40, 80, 240, or 480 x 106 CAR+ T cells.

Synthekine Announces U.S. FDA Clearance of IND Application for CD19 CAR-T and Orthogonal IL-2 Combination Therapy, SYNCAR-001 + STK-009, for Treatment of Lupus Without Lymphodepletion

Retrieved on: 
Tuesday, March 26, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, LN, Risk, Patient, NYU, SLE, IND, Investigational New Drug, Safety, Lupus nephritis, Inc., CD19, Food, Medicine, Pharmaceutical industry

SYNCAR-001 + STK-009 is a cytokine-inducible cell therapy regimen built on Synthekine’s proprietary orthoIL-2 technology.

Key Points: 
  • SYNCAR-001 + STK-009 is a cytokine-inducible cell therapy regimen built on Synthekine’s proprietary orthoIL-2 technology.
  • The SYNCAR-001 + STK-009 combination therapy is in a Phase 1 study ( NCT05665062 ) in CD19+ hematologic malignancies.
  • “However, successful treatment with CD19 CAR-Ts requires patients to be lymphodepleted, a significant burden on the patient, physician and healthcare system.
  • By leveraging Synthekine’s orthoIL-2 technology, STK-009 has the potential to drive SYNCAR-001 cell engraftment and controlled cell expansion without lymphodepletion.

Equillium Reports on Fourth Quarter and Full Year 2023 Financial Results and Corporate and Clinical Highlights

Retrieved on: 
Monday, March 25, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Itolizumab, Organic acid, Harvard Medical School, Exercise, Alopecia areata, ASN, Partnership, Patient, Gastrointestinal tract, ACR, IL-9, Acquisition, G&A, MPA, Dermatology, Investment, MPH, Therapy, Eosinophilic esophagitis, Retirement, Inflammatory bowel disease, Lupus nephritis, JAK, 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 fourth quarter and full year 2023, as well as corporate and clinical highlights.

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 fourth quarter and full year 2023, as well as corporate and clinical highlights.
  • Research and development (R&D) expenses for the fourth quarter of 2023 were $9.2 million, compared with $8.5 million for the same period in 2022.
  • General and administrative (G&A) expenses for the fourth quarter of 2023 were $3.2 million, compared with $5.2 million for the same period in 2022.
  • Net cash used in operating activities in the fourth quarter was $5.7 million.

Adicet Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Tuesday, March 19, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, ChromeOS, Administration, MCL, ASH, Protocol, Patient, Tumor microenvironment, Holocene, G&A, CD70, Cancer, Tropism, Renal cell carcinoma, NHL, IND, Drug, Mantle cell lymphoma, Research and development, Society, TGF, ATM, Safety, FDA, Lupus nephritis, Autoimmunity, 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 reported financial results and operational highlights for the fourth quarter and year ended December 31, 2023.

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 reported financial results and operational highlights for the fourth quarter and year ended December 31, 2023.
  • In December 2023, the FDA cleared the Company’s IND application for ADI-001 in lupus nephritis.
  • Adicet plans to initiate a Phase 1 study to evaluate the safety and efficacy of ADI-001 in lupus nephritis during the second quarter of 2024.
  • Preliminary clinical data from the trial are expected in the fourth quarter of 2024 or first quarter of 2025, pending study site activation progression and patient enrollment.

Kezar Life Sciences Reports Fourth Quarter and Year End 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 14, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Research, Week, Autoimmune hepatitis, NMPA, ALT, AIH, Patient, CRR, Cohort, G&A, CDE, UPCR, IND, Clinical trial, Therapy, KZR, Safety, Pharmacokinetics, Lupus nephritis, Total, Pharmaceutical industry

(Nasdaq: KZR), a clinical-stage biotechnology company developing breakthrough treatments for immune-mediated and oncologic disorders, today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a business update.

Key Points: 
  • (Nasdaq: KZR), a clinical-stage biotechnology company developing breakthrough treatments for immune-mediated and oncologic disorders, today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a business update.
  • Research and development (R&D) expenses for the fourth quarter of 2023 increased by $7.7 million to $22.6 million, compared to $14.9 million in the fourth quarter of 2022.
  • General and administrative (G&A) expenses for the fourth quarter of 2023 increased by $0.6 million to $5.8 million compared to $5.2 million in the fourth quarter of 2022.
  • Restructuring and impairment charges for the fourth quarter of 2023 were $6.2 million.

Sana Biotechnology Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates

Retrieved on: 
Thursday, February 29, 2024
Neoplasm, CD47, VIVID, CD19, Exercise, Science Translational Medicine, Bone marrow, Lymphoid leukemia, Lupus nephritis, CTA, Biotechnology, Escape Room, Research and development, GLEAM, ANCA, GAAP, Sana, Insulin, Development, Immune system, Regeneration, ASH, CD22, AACR, B cell, Safety, Immunosuppression, Diabetes, Patent, IND, Insurance, Nature Biotechnology, NHL, Cancer, CLL, Contingency, Cell, NHP, Organoid, Autoimmunity, Administration, Cell Stem Cell, Patient, HIP, Nature Communications, ISSCR, C-peptide, Vaccine

The Investigational New Drug Application (IND) cleared in 4Q 2023, and Sana expects to share initial data in 2024.

Key Points: 
  • The Investigational New Drug Application (IND) cleared in 4Q 2023, and Sana expects to share initial data in 2024.
  • The Clinical Trial Application (CTA) cleared in 4Q 2023, and Sana expects initial data to be shared in the first half of 2024.
  • Non-GAAP research and development expense in 2023 excludes an expense related to the impairment of certain lab equipment and leasehold improvements, primarily due to the portfolio prioritization in the fourth quarter of 2023.
  • A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under “Non-GAAP Financial Measures.”

Atara Biotherapeutics Receives FDA Clearance of IND Application in Lupus Nephritis for ATA3219, an Allogeneic CAR T Therapy

Retrieved on: 
Thursday, February 29, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Investigational New Drug, Woman, Autoimmune disease, Physician, FDA, Food, CD19, Epstein–Barr virus, Risk, Leukapheresis, Prevalence, Safety, Lupus, Kidney, ATRA, EBV, Disease, Patient, Lupus nephritis, SLE, IND, Tissue, Mortality, Cancer

We are eager to address the significant unmet need in lupus nephritis as we initiate our Phase 1 trial,” said Pascal Touchon, President and Chief Executive Officer of Atara.

Key Points: 
  • We are eager to address the significant unmet need in lupus nephritis as we initiate our Phase 1 trial,” said Pascal Touchon, President and Chief Executive Officer of Atara.
  • Subjects will receive lymphodepletion treatment followed by ATA3219 at a dose of 40, 80, or 160 x 106 CAR+ T cells.
  • “CAR T cells can naturally infiltrate deep into target tissues to mediate B-cell depletion and produce durable responses.
  • The ATA3219 IND submission included in vitro data reflecting the CD19 antigen-specific functional activity of ATA3219 and CAR-mediated activity against B cells from SLE patients.