Immunoglobulin G

SPEVIGO® approved for expanded indications in China and the US

Retrieved on: 
Tuesday, March 19, 2024
Arthralgia, Urinary tract infection, Uncertainty, Human, NMPA, Psoriasis, Disease, Multiple organ dysfunction syndrome, Incidence, Risk, GPP, Boehringer Ingelheim, Patient, Ageing, Executive officer, Immunoglobulin G, Anxiety, Doctor of Philosophy, MD, Quality of life, Flare, Injection site reaction, Clinical trial, Skin, Fever, Immune system, Pain, Itch, Food, FDA, Yale University, Fear

In the trial with 123 patients, no flares were observed after week 4 of SPEVIGO® subcutaneous treatment in the high-dose group (n=30).13,14,15,16 In the Effisayil® 2 trial, SPEVIGO® was associated with an increased incidence (≥9 cases per 100 patient-years) of injection site reaction, urinary tract infection, arthralgia, and pruritus compared to placebo.

Key Points: 
  • In the trial with 123 patients, no flares were observed after week 4 of SPEVIGO® subcutaneous treatment in the high-dose group (n=30).13,14,15,16 In the Effisayil® 2 trial, SPEVIGO® was associated with an increased incidence (≥9 cases per 100 patient-years) of injection site reaction, urinary tract infection, arthralgia, and pruritus compared to placebo.
  • “Until now, people living with GPP have not had any approved options to treat their disease,” said Bruce Strober, MD, PhD, Clinical Professor, Dermatology, Yale University and Central Connecticut Dermatology.
  • “Experiencing GPP can be mentally and physically devastating, leaving those affected with uncertainty and fear of the next episode.
  • Therefore, expanding the treatment of GPP is a critical step towards addressing patients’ needs.”

IMUNON Files IND Application to Begin Human Testing of IMNN-101

Retrieved on: 
Wednesday, March 13, 2024
Drug discovery, COVID-19, Vaccine, DNA, Messenger, SARS-CoV-2, Trial of the century, IND, Infection, Immunity, Safety, Immunoglobulin G, FDA, Food

LAWRENCEVILLE, N.J., March 13, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for IMNN-101 for a Phase 1 clinical study with a seasonal COVID-19 booster vaccine. Following acceptance by the FDA, enrollment in this human proof-of-concept study is expected to begin in the second quarter of 2024.

Key Points: 
  • Following acceptance by the FDA, enrollment in this human proof-of-concept study is expected to begin in the second quarter of 2024.
  • The primary objectives of the Phase 1 study are to evaluate the vaccine safety, tolerability and neutralizing antibody response and its durability in healthy adults.
  • “We are delighted to have completed the work necessary to file this IND application and look forward to demonstrating proof-of-concept for our PlaCCine platform in COVID-19.
  • We’re looking forward to generating the proof-of-concept data necessary to begin these dialogues,” Mr. Tardugno added.

Immunovant Awarded U.S. Patent for IMVT-1402

Retrieved on: 
Tuesday, March 12, 2024
Neonatal Fc receptor, LDL, Immunoglobulin G, Serum albumin, Patent, Autoimmune disease

NEW YORK, March 12, 2024 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced that the United States Patent and Trademark Office has issued U.S. Patent No.

Key Points: 
  • NEW YORK, March 12, 2024 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced that the United States Patent and Trademark Office has issued U.S. Patent No.
  • 11,926,669 (“the ‘669 patent”) for IMVT-1402, the Company’s second-generation antibody targeting the neonatal fragment crystallizable receptor (FcRn).
  • Not including any potential patent term extension, the ‘669 patent will expire on June 23, 2043.
  • IMVT-1402 is being developed by Immunovant based on antibody discovery efforts by HanAll Biopharma.

Longhorn Vaccines and Diagnostics Presents at World Vaccine Congress on Advantages of Single Peptide Vaccine for Broad Coverage of Human and Avian Influenza Viruses

Retrieved on: 
Tuesday, April 2, 2024
Health, Infectious Diseases, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, Congress, Isotype, Influenza, Group 1, Public, Vaccine, Epitope, ELISA, Mouse, Immunoglobulin G, IND, Immunity, InvivoGen, Poster, Peptide

Results from the poster show that LHNVD-110 generated broadly reactive antibodies to human and highly pathogenic avian influenza viruses while neutralizing seasonal and pandemic influenza strains.

Key Points: 
  • Results from the poster show that LHNVD-110 generated broadly reactive antibodies to human and highly pathogenic avian influenza viruses while neutralizing seasonal and pandemic influenza strains.
  • This data mirrors previous studies with LHNVD-105, a dual peptide vaccines containing the same epitopes.
  • Using a single peptide provides a more cost-effective and easily scalable approach to such a universal influenza vaccine.
  • That is why using peptide-based vaccines with broad strain coverage may offer useful strategies towards preventing influenza, no matter the strain.

Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer

Retrieved on: 
Tuesday, April 2, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, Breast cancer, Goserelin, Patient, Lung, Social media, Immunoglobulin G, National Cancer Institute, Neoplasm, Merck & Co., TNBC, Capecitabine, DXD, BRCA, Clinical Cancer Research, Metabolism, Immunology, Biopharmaceutical, World Health Organization, Cancer, Safety, ADC, BLA, Daiichi Sankyo, Vinorelbine, IHC, Mutation, NSCLC, Disease, Merck, AKT, Death, MD, AstraZeneca, PARP, Oncotarget, PFS, FDA, OS, HER2, Eribulin, Cleavage, Progression-free survival, Triple-negative breast cancer, Female, Emerging, Olaparib, Biology, Sapporo Medical University, Medicine, Pharmaceutical industry

The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.

Key Points: 
  • The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.
  • A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancers, including NSCLC, triple-negative breast cancer (TNBC) and HR-positive, HER2-negative breast cancer.
  • Comparative Overall Survival of CDK4/6 Inhibitors Plus Endocrine Therapy vs. Endocrine Therapy Alone for Hormone receptor-positive, HER2-negative metastatic breast cancer.

OmniAb Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights

Retrieved on: 
Wednesday, March 20, 2024
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Research, Multiple myeloma, Lung cancer, Partner, NMPA, Growth, NSCLC, CIDP, Partnership, Telephone, GSK, Patient, TED, NASDAQ Biotechnology Index, Epitope, Artificial intelligence, Sale, Myasthenia gravis, Neonatal Fc receptor, Fluorouracil, Graves' ophthalmopathy, Investment, Teclistamab, NBI, National Medical Products Administration, Johnson & Johnson, Drug development, Safety, Chicken, Machine learning, Gastrointestinal cancer, Immunoglobulin G, BLA, Chronic inflammatory demyelinating polyneuropathy, Pharmaceutical industry

OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and 12 months ended December 31, 2023, and provided operating and partner program updates.

Key Points: 
  • OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and 12 months ended December 31, 2023, and provided operating and partner program updates.
  • OmniAb launched two new technologies during 2023 including OmniDeep™ and, during the fourth quarter, OmnidAb™.
  • Fourth quarter 2023 and recent partner highlights include the following:
    Immunovant reported positive initial results for batoclimab in Graves’ disease (GD).
  • OmniAb was added to the Nasdaq Biotechnology Index (NBI) in the fourth quarter.

Merck Announces Positive Data on V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Demonstrated Immune Responses in Adults

Retrieved on: 
Tuesday, March 19, 2024
Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, Emory University, Antigen, Streptococcus, International Society, HIV, Risk, Global health, Patient, Cohort, Hospital, Merck & Co., Aes, OPA, Epidemiology, Training school (United States), PCV20, Immunoglobulin G, Attenuated vaccine, MRK, Pediatrics, CDC, Vaccination, PPSV23, Community-acquired pneumonia, Food, FDA, PDUFA, Medicine, Vaccine

V116 also elicited higher immune responses than the studied comparators for the serotypes unique to V116 in all STRIDE studies presented at the meeting.

Key Points: 
  • V116 also elicited higher immune responses than the studied comparators for the serotypes unique to V116 in all STRIDE studies presented at the meeting.
  • If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults.
  • Participants were enrolled based on previous pneumococcal vaccination with PPSV23, PCV15, PCV13 (pneumococcal 13-valent conjugate vaccine), PPSV23+PCV13, PCV13+PPSV23 or PCV15+PPSV23, and received either V116, PCV15 or PPSV23.
  • V116 elicited comparable immune responses to the comparator, PCV15+PPSV23, for all 13 shared serotypes and higher immune responses for the eight serotypes covered only by V116.

Alpine Immune Sciences Provides Corporate Update and Full Year 2023 Financial Results

Retrieved on: 
Monday, March 18, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Research program, Administration, Congress, Development, WT, Lupus, Patient, Immunoglobulin A, Glomerular filtration rate, SLE, Inflammation, MD, UPCR, Neonatal Fc receptor, American College, Investment, Clinical trial, Society, EGFR, Nephrology, BAFF, Proteinuria, Immunoglobulin G, Autoimmunity, ALPN, Pharmaceutical industry

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today reported full year 2023 financial results and company highlights for the fourth quarter ended December 31, 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 full year 2023 financial results and company highlights for the fourth quarter ended December 31, 2023.
  • “2023 was a transformational year for Alpine, with initial IgA nephropathy (IgAN) data presented at the American Society of Nephrology Kidney Week 2023 suggesting a best-in-class profile for povetacicept, our next-generation dual BAFF/APRIL inhibitor.
  • In addition, povetacicept was well tolerated during subcutaneous administration, with no instances of IgG
  • Net Loss: Net loss for the year ended December 31, 2023, was $32.2 million compared to $57.8 million for the same period in 2022.

Advanced Infliximab Model Now Available from DoseMe

Retrieved on: 
Friday, March 15, 2024
Technology, Research, Health Technology, Software, Biotechnology, Health, Pharmaceutical, Data Management, Science, Inflammatory bowel disease, Risk, Infliximab, IBD, Patient, Immunoglobulin G, BCPS, Doctor of Pharmacy, Inflammation, Vaccine

DoseMe , a leading provider of model-informed precision dosing, today announced the availability of its Infliximab model.

Key Points: 
  • DoseMe , a leading provider of model-informed precision dosing, today announced the availability of its Infliximab model.
  • Infliximab (IFX) is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and human components that inhibit tumor necrosis factor-alpha(TNFα).
  • "We continue to enhance our models, and this model may predict infliximab concentration in patients with anti-drug antibodies,” added Roy.
  • “Both the learning set and validation set of this model had a large diversity in an indication of the patients, thus making this model especially equipped to dose infliximab for many indications.”
    For more information and an overview of all models currently available, visit https://doseme-rx.com/why-dosemerx/drug-packages

Takeda Announces Positive Topline Results from Phase 2 Study Evaluating Mezagitamab (TAK-079), a Potential Best-in-Class Anti-CD38 Monoclonal Antibody, for Primary Immune Thrombocytopenia

Retrieved on: 
Wednesday, March 13, 2024
Neurology, Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Clinical Trials, Fast track (FDA), Psoriasis, Cell, Disease, Risk, Patient, Megakaryocyte, Immunoglobulin G, ITP, B cell, Quality of life, Platelet, Autoantibody, Gastrointestinal tract, CD38, Bleeding, Safety, Dravet syndrome, Blood, Lennox–Gastaut syndrome, Fatigue, Fiscal, Food, Autoimmune disease, Pharmaceutical industry

Takeda ( TSE:4502/NYSE:TAK ) today announced positive topline results from a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced positive topline results from a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP).
  • An interim analysis of the ongoing Phase 2 study demonstrated positive safety and efficacy results.
  • Based on these positive results, and following consultation with global health authorities, Takeda plans to initiate a global Phase 3 trial of mezagitamab in ITP in fiscal year 2024.
  • Results from the Phase 2 trial have no impact on the full year consolidated reported forecast for the fiscal year ending March 31, 2024 (Fiscal Year 2023).