Immunoglobulin A

Travere Therapeutics Announces Confirmatory Data from the Phase 3 PROTECT Study of FILSPARI® Demonstrating Long-Term Kidney Function Preservation in IgA Nephropathy; Narrowly Missing eGFR Total Slope Endpoint versus Active Control, Irbesartan

Retrieved on: 
Thursday, September 21, 2023
Medicine, Kidney failure, International, Heart Protection Study, CMA, Jay Traver, European Medicines Agency, Clinical trial, EGFR, European Directive on Traditional Herbal Medicinal Products, CSL Vifor, Immunoglobulin A, Dialysis, Committee, EMA, Proteinuria, Conditional, Nephrology, ANCOVA, Shanda, Publication, Patient, Division, Risk, Irbesartan, Kidney transplantation, Webcast, Committee for Medicinal Products for Human Use, FDA, Therapy, PROTECT, Kidney disease, Safety, CHMP, Hydraulic machinery, Medical device, Pharmaceutical industry, EU, IgA nephropathy

This outcome is incredibly important for IgAN patients, who face the risk of progression to kidney failure in their lifetime.

Key Points: 
  • This outcome is incredibly important for IgAN patients, who face the risk of progression to kidney failure in their lifetime.
  • “Since our accelerated approval, we’ve continued to hear inspiring stories of the impact this medicine is having on people living with IgAN.
  • While eGFR total slope narrowly missed statistical significance, the overall evidence from PROTECT suggests potential long-term benefit of FILSPARI as a foundational treatment for patients with IgAN.
  • Following the live webcast, an archived version of the call will be available for 30 days on the Company’s website.

EQS-News: Biotest AG: Biotest treats first patient with severe community-acquired pneumonia in phase III trial with trimodulin

Retrieved on: 
Saturday, September 16, 2023
Multiple organ dysfunction syndrome, IMV, Failure, CAP, Oxygen, COVID-19, Immunoglobulin M, Immunoglobulin A, Inflammation, Septic shock, Sepsis, Plasma, Patient, Immunoglobulin G, Mortality, Bronchopneumonia, ICU, III, Pharmaceutical industry, SCAP

Biotest announced today that the first patient with sCAP has been treated in the phase III ESsCAPE trial in an intensive care unit.

Key Points: 
  • Biotest announced today that the first patient with sCAP has been treated in the phase III ESsCAPE trial in an intensive care unit.
  • This multinational phase III clinical trial is expected to enrol approximately 590 adult patients with severe Community Acquired Pneumonia (sCAP).
  • In the CIGMA trial a subgroup of patients with evidence of severe inflammation showed an encouraging reduction in the mortality rate when treated with trimodulin.
  • In addition to clinical development for sCAP, trimodulin is also currently in development for the treatment of COVID-19.

Vaxart Announces Topline Data from the Phase 2 Challenge Study of its Monovalent Norovirus Vaccine Candidate

Retrieved on: 
Wednesday, September 6, 2023
Infection, ASC, Vaxart, Norovirus, Immunoglobulin G, Conference call, AGE, Immunoglobulin A, Antibody, Nursing, SAN, Conference, Pharmaceutical industry, Vaccine, Vaccination

SOUTH SAN FRANCISCO, Calif., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced top-line data from the Phase 2 challenge study of its oral tablet monovalent norovirus vaccine candidate (NCT05212168).

Key Points: 
  • ET
    SOUTH SAN FRANCISCO, Calif., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced top-line data from the Phase 2 challenge study of its oral tablet monovalent norovirus vaccine candidate ( NCT05212168 ).
  • The Phase 2 challenge study enrolled 165 healthy adults, who were randomized 1:1 to receive Vaxart’s monovalent oral tablet vaccine targeting the norovirus GI.1 genotype or placebo.
  • Vaccination also led to a reduction in norovirus AGE in the vaccine arm compared to placebo, but this was not statistically significant.
  • In a prespecified analysis, the study also showed an 85% decrease in viral shedding in the vaccine arm compared with placebo.

Alpine Immune Sciences Announces Initiation of Dosing in 240 mg IgA Nephropathy Cohort of Povetacicept Clinical Study (RUBY-3)

Retrieved on: 
Wednesday, August 30, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Clinical Trials, Hypersensitivity, Alpine, Immunoglobulin A, IgA nephropathy, ALPN, Immunoglobulin G, Hypogammaglobulinemia, SMC, Autoimmunity, Safety, Inflammation, Vaccine

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced the successful initiation of the second IgA nephropathy (IgAN) dose cohort in RUBY-3, a phase 1b/2a study in autoimmune glomerulonephritis.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced the successful initiation of the second IgA nephropathy (IgAN) dose cohort in RUBY-3, a phase 1b/2a study in autoimmune glomerulonephritis.
  • Safety Monitoring Committee (SMC) review has determined that repeat dosing of povetacicept in the first IgAN dose cohort (80 mg subcutaneously once every 4 weeks) has been safe and well-tolerated to date, with no serious or severe adverse events, no events of hypogammaglobulinemia (IgG
  • Dose escalation has been endorsed, and enrollment of the second IgAN dose cohort (240 mg subcutaneously every 4 weeks) has been initiated.
  • “We look forward to providing more detailed clinical updates later this year in appropriate scientific forums.”

Thermo Fisher Scientific Announces the Launch of the EXENT® Solution with IVDR Certification

Retrieved on: 
Thursday, August 24, 2023
Research, Technology, Professional Services, Software, Biotechnology, Data Analytics, Health, Data Management, Science, Oncology, Mayo Clinic, IVDR, Serum, Multiple myeloma, Immunoglobulin M, Bone marrow, Immunoassay, GAM, Thermo Fisher Scientific, Immunoglobulin A, Binding site, The Advanced Visualizer, HIV disease progression rates, Acquisition, Patient, Laboratory, Immunoglobulin G, Diagnosis, Matrix-assisted laser desorption/ionization, World Health Organization, Medical device, Medical imaging, Fine chemical

Thermo Fisher Scientific, the world leader in serving science, today announced the commercial launch of the EXENT® Solution, after receiving IVDR certification*.

Key Points: 
  • Thermo Fisher Scientific, the world leader in serving science, today announced the commercial launch of the EXENT® Solution, after receiving IVDR certification*.
  • The EXENT Solution is now commercially available in the following countries: Belgium, France, Germany, Italy, the Netherlands, Spain and United Kingdom.
  • “The EXENT Solution represents a significant breakthrough in innovation for the detection and monitoring of monoclonal immunoglobulins,” said Dr. Stephen Harding, Chief Scientific Officer, Protein Diagnostics, Thermo Fisher.
  • Earlier this year, Thermo Fisher Scientific completed the acquisition of The Binding Site, adding protein diagnostics solutions, including diagnosis and monitoring for monoclonal gammopathies, to its specialty diagnostics portfolio.

Selecta Biosciences Reports Second Quarter 2023 Financial Results and Updates on Strategic Initiative Designed to Maximize Stockholder Value Associated with SEL-212 Economics

Retrieved on: 
Thursday, August 17, 2023
Partnership, Swedish Orphan Biovitrum, Astellas Pharma, Serum, Telephone, Investigational New Drug, Immunoglobulin A, Antibody, AAV, Congress, Development, Methylmalonic acidemia, Selecta, IgA nephropathy, Investment, European, Administration, Immunoglobulin G, European Alliance of Associations for Rheumatology, EULAR, Research, BLA, Gout, European Alliance, Combination, Pharmaceutical industry, Vaccine, Rheumatology, Patient

WATERTOWN, Mass., Aug. 17, 2023 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR™ platform to develop tolerogenic therapies for autoimmune diseases and gene therapies, today reported financial results for the second quarter ended June 30, 2023 and provided a business update.

Key Points: 
  • As part of this initiative, the Company plans to:
    Continue to Advance SEL-212 in Patients with Chronic Refractory Gout in Partnership with Sobi.
  • The decrease was primarily the result of the capital prioritization initiative that was enacted in the second quarter of 2023.
  • Net (Loss) Income: For the second quarter of 2023, Selecta reported net loss of $11.4 million, or basic net loss per share of $(0.07).
  • Selecta’s management will host a conference call at 8:30 AM ET today to provide a corporate update and review the Company’s second quarter 2023 financial results and strategic updates.

Alpine Immune Sciences Reports Second Quarter 2023 Financial Results

Retrieved on: 
Monday, August 14, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Cold agglutinin disease, American Society of Nephrology, Immunoglobulin A, ASN, Development, IgA nephropathy, MD, Patient, ALPN, Investment, Administration, Lupus nephritis, BAFF, Society, Autoimmunity, Inflammation, Pharmaceutical industry, Vaccine, Nursing, Cryptocurrency, Alpine, AbbVie

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today reported financial results and company highlights for the second quarter ended June 30, 2023.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today reported financial results and company highlights for the second quarter ended June 30, 2023.
  • “During the first half of 2023 we achieved several important milestones in the development of povetacicept, our potentially best-in-class dual BAFF/APRIL inhibitor being advanced in multiple autoimmune diseases.
  • Continue to enroll patients in RUBY-3, a phase 1b/2a, open-label study of povetacicept in autoimmune glomerulonephritis, including IgA nephropathy, lupus nephritis, and primary membranous nephropathy.
  • The respective increases of $0.8 million and $1.4 million were primarily attributable to increases in personnel costs.

Molecular Templates, Inc. Reports Second Quarter 2023 Financial Results and Business Update

Retrieved on: 
Thursday, August 10, 2023
Intellectual property, PR, Therapy, PD, Symantec Endpoint Protection, Bank statement, Neoplasm, Immunomodulatory imide drug, Food, Aes, Food and Drug Administration, RECIST, MHC, Cancer, Bristol Myers Squibb, NSCLC, Immunoglobulin A, Bone disease, Sale, Monocyte, CD8, HIV disease progression rates, MDSC, PD-L1, Patient, CMV, TME, Biology, BMS, Private placement, FDA, ETB, Pembrolizumab, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Partial-response maximum-likelihood, WalletHub, BCMA, Safety, Conference, Pharmaceutical industry, Nursing, Medical imaging, Security (finance), Vaccine, Medical device, Palladium

Revenues for the second quarter of 2023 were $6.9 million, compared to $4.4 million for the same period in 2022.

Key Points: 
  • Revenues for the second quarter of 2023 were $6.9 million, compared to $4.4 million for the same period in 2022.
  • Revenues for the second quarter of 2023 were comprised of revenues from collaborative research and development agreements with Bristol Myers Squibb and grant revenue from CPRIT.
  • Total research and development expenses for the second quarter of 2023 were $13.4 million, compared with $21.4 million for the same period in 2022.
  • Total general and administrative expenses for the second quarter of 2023 were $5.2 million, compared with $6.6 million for the same period in 2022.

Omeros Corporation Reports Second Quarter 2023 Financial Results

Retrieved on: 
Wednesday, August 9, 2023
Neurology, Biotechnology, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Other Health, DSM-IV codes, Survival, Tardive dyskinesia, Bangladesh Technical Education Board, Data analysis, Patent, Investment, Patient, Congress, BLA, Inflammation, Emory University, Therapy, Paroxysmal nocturnal hemoglobinuria, European Hematology Association, Research, Emory, Government, Proteinuria, Kidney International, CUD, Glomerulus, Manuscript, L-DOPA, Hematuria, Safety, Omeros, COVID-19, Inflammation Research, Immunoglobulin A, Fibrosis, PIN, Cancer, PNH, National Institute on Drug Abuse, LID, PDE7, Hemolysis, Complement, Clinical trial, Mannan-binding lectin, Sale, Trial of the century, IgA nephropathy, Corporation, NIDA, Society, C5, Pharmaceutical industry, Reinsurance, Music, Security (finance), Vaccine, Video game, Frontiers, Hematology, Immunology, Agency

“Our team continued building significant shareholder value throughout the second quarter of 2023,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer.

Key Points: 
  • “Our team continued building significant shareholder value throughout the second quarter of 2023,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer.
  • Total costs and expenses for the second quarter of 2023 were $40.9 million compared to $37.4 million for the second quarter of 2022.
  • Interest expense during the second quarter of 2023 was $7.9 million compared to $4.9 million during the prior year quarter.
  • During the second quarter of 2023, we earned $4.5 million in interest and other income compared to $0.7 million in the prior year quarter.

Chinook Therapeutics Announces First Patient Enrolled in Pivotal Phase 3 BEYOND Study of Zigakibart (BION-1301) for Patients with IgA Nephropathy

Retrieved on: 
Friday, July 28, 2023
University, MBBS, Galactose, University of New South Wales, Medicine, Immunoglobulin A, Doctor of Philosophy, Dialysis, Kidney disease, Proteinuria, Patient, Kidney, FASN, Health, Therapy, Safety, Disease, Pharmaceutical industry, FRACP, IgA nephropathy, Chinook

SEATTLE, July 28, 2023 (GLOBE NEWSWIRE) -- Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, today announced that the first patient with IgA nephropathy (IgAN) has been enrolled in the BEYOND study, a pivotal phase 3 clinical trial evaluating the safety and efficacy of zigakibart (BION-1301), a potentially disease-modifying anti-APRIL monoclonal antibody.

Key Points: 
  • SEATTLE, July 28, 2023 (GLOBE NEWSWIRE) -- Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, today announced that the first patient with IgA nephropathy (IgAN) has been enrolled in the BEYOND study, a pivotal phase 3 clinical trial evaluating the safety and efficacy of zigakibart (BION-1301), a potentially disease-modifying anti-APRIL monoclonal antibody.
  • “Initiation of the phase 3 BEYOND study is an important step towards our goal of providing an innovative treatment option for patients with IgAN, a disease with high unmet need and limited treatment options,” said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics.
  • “IgAN is the most common primary glomerular disease worldwide with limited treatment options currently available, causing many patients to progress to end-stage kidney disease, requiring dialysis or kidney transplant.
  • With the potential to be disease-modifying based on the encouraging results observed in the phase 1/2 study, I believe zigakibart could be an important new therapeutic treatment option for patients with IgAN.”