EULAR

Cabaletta Bio Reports First Quarter 2024 Financial Results and Provides Business Update

Retrieved on: 
onsdag, maj 15, 2024
Patient, Cell, Systemic scleroderma, Movement, Lupus, Pemphigus vulgaris, Food, Myopathy, Investment, Letter, CD19, FDA, Disease, MuSK protein, MPV, Conference, Cytokine release syndrome, Dermatology, Congress, Growth, Gene, Immunoglobulin therapy, Potential, Juvenile dermatomyositis, Cyclophosphamide, Dermatomyositis, Symposia, EULAR, IIM, Society, Health Canada, A1, Observation, Research, Clinical trial, DLT, Myositis, Annual general meeting, CRS, Pharmaceutical industry

PHILADELPHIA, May 15, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today reported financial results for the first quarter ended March 31, 2024, and provided a business update.

Key Points: 
  • PHILADELPHIA, May 15, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today reported financial results for the first quarter ended March 31, 2024, and provided a business update.
  • In March 2024, Cabaletta announced the first patient had been dosed in the Phase 1/2 RESET-Myositis trial.
  • Cabaletta expects to report initial clinical data from the Phase 1/2 RESET-SSc™ trial in the second half of 2024.
  • Cabaletta expects to report initial clinical data from the Phase 1/2 RESET-MG™ trial in the second half of 2024.

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.

Monte Rosa Therapeutics Announces First Quarter 2024 Financial Results and Provides Corporate Update

Retrieved on: 
torsdag, maj 9, 2024
Transfer, FDA, Research, Inflammation, Cell cycle, IND, CNS, Prostate cancer, AACR, Cancer, Autoimmunity, Lung cancer, Traffic barrier, MGD, Food, European Alliance, Conference, Roche, DDW, Pericarditis, Therapy, NSCLC, Rat, Ulcerative colitis, Poster, NLRP3, CCNE1, SCLC, Finance, Triple-negative breast cancer, Consultant, Public expenditure, Obesity, Gout, GLP, DSM-IV codes, Clinical trial, Toxicology, CDK2, G&A, Investigational New Drug, MYC, Research and development, EULAR, Carcinoma, Administration, Rheumatoid arthritis, Neoplasm, POC, Dermatology, Growth, Pharmaceutical industry

“We’re excited by the significant advances made across our entire portfolio, including both our oncology and immunology/inflammation programs,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics.

Key Points: 
  • “We’re excited by the significant advances made across our entire portfolio, including both our oncology and immunology/inflammation programs,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics.
  • The Company is on track to determine the recommended Phase 2 dose (RP2D) in Q2 2024 and report Phase 1 study results in H2 2024.
  • Announce the recommended Phase 2 dose for the MRT-2359 Phase 1/2 study in Q2 2024 and report Phase 1 clinical results in H2 2024.
  • Net Loss: Net loss for the first quarter of 2024 was $32.0 million, compared to $33.3 million for the fourth quarter of 2023.

Aurinia Presents Data Reinforcing LUPKYNIS® Safety and Efficacy for People with Lupus Nephritis at Congress of Clinical Rheumatology East 2024

Retrieved on: 
torsdag, maj 9, 2024
Research, FDA, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Congress, Glucocorticoid, Safety, Patient, Kidney, Lupus nephritis, Proteinuria, CNI, EULAR, Rheumatology, Steroid, Cyclophosphamide, Comparison, CCR, Standard of care, MMF, Pharmaceutical industry

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), today announced the presentation of two studies at the annual Congress of Clinical Rheumatology (CCR) East 2024 taking place in Destin, FL, May 9-12.

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), today announced the presentation of two studies at the annual Congress of Clinical Rheumatology (CCR) East 2024 taking place in Destin, FL, May 9-12.
  • The data reinforce previous findings on the safety and effectiveness of LUPKYNIS (voclosporin), a second generation calcineurin inhibitor (CNI), in combination with MMF and steroids, for the treatment of adult patients with active lupus nephritis (LN), as shown in the AURORA Clinical Program.
  • Safety and efficacy outcomes for propensity-matched patients with active LN from the AURA-LV plus AURORA 1 studies were assessed at three and six months.
  • “Early reduction in proteinuria after initial treatment has been associated with improved long-term kidney outcomes in lupus nephritis,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia.

argenx Advances Clinical Development of Efgartigimod in Primary Sjogren’s Disease

Retrieved on: 
onsdag, mars 27, 2024
Disease, Patient, Biomarker, STAR, Euronext, Woman, EULAR, Safety, Composite, Immunoglobulin G, RHO, Serology

“We are excited to be advancing efgartigimod’s development in Sjogren’s disease based on the totality of the data generated from the RHO study,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx.

Key Points: 
  • “We are excited to be advancing efgartigimod’s development in Sjogren’s disease based on the totality of the data generated from the RHO study,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx.
  • “Consistent with our indication selection strategy, we confirmed our IgG biology hypothesis with these data, and now have a demonstrated clinical effect across multiple efficacy scales to support proof-of-concept.
  • Sjogren’s disease can be debilitating, predominantly affects women, and given its heterogeneous nature, is often misdiagnosed with its symptoms poorly understood.
  • Efficacy assessments showed a treatment effect across multiple clinical endpoints, which were also consistent with biomarker data.

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

Retrieved on: 
måndag, 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.

OncoOne Announces Formation of Clinical Advisory Board to Support Development of ON104 for Chronic Inflammatory Diseases

Retrieved on: 
tisdag, mars 12, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Other Health, European Alliance, United, United Nations, Asthma, AAP, Yale school, CD74, Hôpital Cochin, Trinity College Dublin, Arthritis & Rheumatology, Molecular medicine, Cancer, University, Publication, Medical school, ASCI, Prognosis, Trinity, Pathology, Diagnosis, Public health, Trinity College, Arthritis, Physiology, Biomarker, Global Health, Nephritis, Society, EULAR, Inflammatory bowel disease, Physician, Pharmaceutical industry

OncoOne , a biotechnology company focused on discovering precision medicines for cancer and autoimmune diseases, announced today the formation of a clinical advisory board to provide strategic and clinical insights for the company’s lead program in immunology, ON104.

Key Points: 
  • OncoOne , a biotechnology company focused on discovering precision medicines for cancer and autoimmune diseases, announced today the formation of a clinical advisory board to provide strategic and clinical insights for the company’s lead program in immunology, ON104.
  • ON104 is a monoclonal antibody targeting the oxidized isoform of the macrophage migration inhibitory factor (oxMIF) for the treatment of chronic inflammatory diseases.
  • His research focuses on arthritis and other inflammatory rheumatic diseases, precision medicine, and the management of complex diseases.
  • Dr. Freissmuth is an inaugural member of OncoOne’s scientific advisory board, where he continues to support the development of the company’s pipeline of biotherapeutics.

Analyze the Clinical Trial Landscape Through the Pharma Competitive Intelligence Monitoring Services by DelveInsight

Retrieved on: 
torsdag, januari 18, 2024
Noise, Forecasting, AACR, ASCO, Intelligence, Consultant, ELCC, ESMO, Environment, Conference, ATS, EULAR, IPF, ASH, News, Diagnosis, ERS, Growth

LAS VEGAS, Jan. 18, 2024 /PRNewswire/ -- DelveInsight, a leading pharma competitive intelligence and consulting solutions company, offers dynamic Pharma Competitive Intelligence Monitoring Services. Through this service, clients can easily monitor developmental assets, clinical trials, regulatory milestones, commercial news, and receive high-priority alerts in real time as well as assess updates via an online dashboard. 

Key Points: 
  • LAS VEGAS, Jan. 18, 2024 /PRNewswire/ -- DelveInsight, a leading pharma competitive intelligence and consulting solutions company, offers dynamic Pharma Competitive Intelligence Monitoring Services .
  • Competitive intelligence monitoring enables companies to swiftly adjust to market fluctuations, comprehend patient needs, address developmental challenges, enhance their overall decision-making processes, and leverage competitive advantage.
  • Demonstrating proficiency in Competitive Intelligence Monitoring, DelveInsight assists clients in fortifying their brand's market standing and company's overall positioning, staying abeam of prevailing industry trends.
  • Leverage our Competitive Intelligence Monitoring Services for precise and effective results:
    Monitor competitors extensively; who are in product development, or those already in the market
    Ask for a proposal to find out how DelveInsight's pharma Competitive intelligence monitoring solutions can assist you.

Analyze the Clinical Trial Landscape Through the Pharma Competitive Intelligence Monitoring Services by DelveInsight

Retrieved on: 
torsdag, januari 18, 2024
Noise, Forecasting, AACR, ASCO, Intelligence, Consultant, ELCC, ESMO, Environment, Conference, ATS, EULAR, IPF, ASH, News, Diagnosis, ERS, Growth

LAS VEGAS, Jan. 18, 2024 /PRNewswire/ -- DelveInsight, a leading pharma competitive intelligence and consulting solutions company, offers dynamic Pharma Competitive Intelligence Monitoring Services. Through this service, clients can easily monitor developmental assets, clinical trials, regulatory milestones, commercial news, and receive high-priority alerts in real time as well as assess updates via an online dashboard. 

Key Points: 
  • LAS VEGAS, Jan. 18, 2024 /PRNewswire/ -- DelveInsight, a leading pharma competitive intelligence and consulting solutions company, offers dynamic Pharma Competitive Intelligence Monitoring Services .
  • Competitive intelligence monitoring enables companies to swiftly adjust to market fluctuations, comprehend patient needs, address developmental challenges, enhance their overall decision-making processes, and leverage competitive advantage.
  • Demonstrating proficiency in Competitive Intelligence Monitoring, DelveInsight assists clients in fortifying their brand's market standing and company's overall positioning, staying abeam of prevailing industry trends.
  • Leverage our Competitive Intelligence Monitoring Services for precise and effective results:
    Monitor competitors extensively; who are in product development, or those already in the market
    Ask for a proposal to find out how DelveInsight's pharma Competitive intelligence monitoring solutions can assist you.

Equillium Presents Positive Data from Phase 1b EQUALISE Study at the 2023 Annual Meeting of the American College of Rheumatology

Retrieved on: 
måndag, november 13, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, EOS, Serum albumin, ALC, European Renal Association, MMF, Itolizumab, Safety, Ono Pharmaceutical, Dialysis, Type, Children's Organ Transplant Association, Patient, Bruce Steel, American College of Rheumatology, Novel, American College, Therapy, Lupus nephritis, Standard of care, ORR, Infection, Partnership, EGFR, CD6, S1P, EULAR, AMP, ACR, Trial of the century, Proteinuria, Pharmaceutical industry, Silviculture, Nursing, UPCR, Medicine, Lupus

“It’s important that we saw both early and large reductions in proteinuria,” said Dr.

Key Points: 
  • “It’s important that we saw both early and large reductions in proteinuria,” said Dr.
  • Results are comparable to those observed in the Phase 3 AURORA1 study of voclosporin (ORR 70% at 6 and 12 months in active treatment).
  • Consistent with the decline in UPCR overtime, subjects were able to taper their systemic corticosteroids over the course of the study.
  • The poster presentation is available on the Presentations page of Equillium’s website under the Lupus tab.