Lenzilumab

Humanigen Enters into Agreement with PCI Pharma Services as Part of Preparations for Commercialization in the United Kingdom

Retrieved on: 
목요일, 6월 16, 2022
Health, Infectious Diseases, Research, Pharmaceutical, Science, Biotechnology, SHIELD, CMML, COVID-19, Risk, Safety, National Health Service, Health care, MHRA, GM, Conditional, ClinicoEconomics and Outcomes Research, Lenzilumab, Knowledge, Graft-versus-host disease, CDMO, Forward-looking statement, Non-Hodgkin lymphoma, Medication, LinkedIn, RAS, PCI, Rheumatoid arthritis, Clinical trial, GM-CSF, Chemokine, UK Health Security Agency, SEC, National Health Service (England), Nasdaq, Neurotoxicity, Granulocyte-macrophage colony-stimulating factor, Twitter, Standard of care, Chronic myelomonocytic leukemia, Patient, Cytokine release syndrome, Gilead Sciences, Degenerative disease, Outcomes research, Goal, Judgement, Pharmaceutical industry, Hospital, Vaccine, Animal, Facebook

Hospitalizations from COVID-19 continue in the United Kingdom with more than 235,000 admitted year-to-date and with ~5,000 currently hospitalized.1 In addition, Humanigen believes that treatment with lenzilumab may deliver economic value to the healthcare system.

Key Points: 
  • Hospitalizations from COVID-19 continue in the United Kingdom with more than 235,000 admitted year-to-date and with ~5,000 currently hospitalized.1 In addition, Humanigen believes that treatment with lenzilumab may deliver economic value to the healthcare system.
  • Lenzilumab binds to and neutralizes GM-CSF, potentially improving outcomes for patients hospitalized with COVID-19.
  • Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), is a late-stage clinical biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm.
  • https://doi.org/10.2147/CEOR.S360741
    Humaneered is a trademark of Humanigen, Inc.
    Yescarta and Tecartus are trademarks of Gilead Sciences, Inc., or its related companies.

Humanigen Reports First Quarter 2022 Financial Results

Retrieved on: 
목요일, 5월 5, 2022
Stem Cells, Biotechnology, Pharmaceutical, Oncology, General Health, Health, Infectious Diseases, Clinical Trials, SHIELD, United Kingdom, COVID-19, CMA, U.S. Securities and Exchange Commission, Forward-looking statement, Twitter, Nasdaq, Neurotoxicity, EUA, Company, NIH, Safety, Chronic myelomonocytic leukemia, Asthma, Centers for Disease Control and Prevention, Judgement, CDC, Chemokine, Patient, Cytokine release syndrome, Security (finance), Projection, RAS, GM-CSF, FDA, Inflammation, Risk, Therapy, Knowledge, Center, Degenerative disease, Gilead Sciences, LinkedIn, GM, Goal, Non-Hodgkin lymphoma, Rheumatoid arthritis, Graft-versus-host disease, Granulocyte-macrophage colony-stimulating factor, Vaccine, Pharmaceutical industry, Lenzilumab, Facebook

Based on these results, Humanigen plans to test lenzilumab in a randomized, multicenter, potentially registrational, Phase 3 SHIELD study to evaluate its efficacy and safety when combined with Yescarta and Tecartus CAR-T therapies in non-Hodgkin lymphoma.

Key Points: 
  • Based on these results, Humanigen plans to test lenzilumab in a randomized, multicenter, potentially registrational, Phase 3 SHIELD study to evaluate its efficacy and safety when combined with Yescarta and Tecartus CAR-T therapies in non-Hodgkin lymphoma.
  • Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), is a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm.
  • Results from preclinical models indicate GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in the cytokine storm.
  • Retrieved May 4, 2022, from https://www.roche.com/investors/events/annual-results-2021
    LENZ and Humaneered are trademarks of Humanigen, Inc.
    Yescarta and Tecartus are trademarks of Gilead Sciences, Inc., or its related companies.

GM-CSF Knock-out CAR-T Study Published in Peer-Reviewed Journal Leukemia

Retrieved on: 
수요일, 4월 20, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, SHIELD, Granulocyte-macrophage colony-stimulating factor, Cytokine release syndrome, GM-CSF, Adoption, Judgement, Lenzilumab, COVID-19, MBA, Twitter, Graft-versus-host disease, Gilead Sciences, Research, NHL, CMML, Toxicity, Chronic myelomonocytic leukemia, Risk, Patient, Goal, GM, Degenerative disease, Toxic shock syndrome, LinkedIn, Blood, Neurotoxicity, Mayo Clinic Cancer Center, Rheumatoid arthritis, Nasdaq, Apoptosis, RAS, SEC, Forward-looking statement, Chemokine, Safety, DLBCL, Disease, Physician, Non-Hodgkin lymphoma, CRS, Knowledge, Neuroinflammation, Synthetic biology, Vaccine, Pharmaceutical industry, Leukemia, Morris, Facebook

Treatments that can prevent ICANS and CRS while potentially improving CAR-T efficacy could address a critical unmet need.

Key Points: 
  • Treatments that can prevent ICANS and CRS while potentially improving CAR-T efficacy could address a critical unmet need.
  • The upcoming Phase 3 CAR-T study, known as SHIELD, will determine the efficacy and safety of prophylactic lenzilumab on the rates of ICANS, CRS, and CAR-T efficacy.
  • The SHIELD trial has been designed to build on the positive results from the ZUMA-19 study.
  • A study of lenzilumab is also underway for patients with chronic myelomonocytic leukemia (CMML) exhibiting RAS pathway mutations.

Humanigen Reports Year-End 2021 Financial Results

Retrieved on: 
월요일, 2월 28, 2022
Science, Stem Cells, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, SHIELD, Chronic myelomonocytic leukemia, Cytokine release syndrome, Infection, CMML, The Lancet, DLBCL, National Institute of Allergy and Infectious Diseases, Research, COVID-19, Oxygen toxicity, National, Clinical trial, Rating, Sale, Safety, Degenerative disease, Neurotoxicity, Steroid, Emergency Use Authorization, ORR, EUA, FDA, R, Nasdaq, Patient, Union, CRS, Survival, C-reactive protein, Standard of care, B-cell lymphoma, National Institute, Research and development, Pharmaceutical industry, Lenzilumab, Lancet

Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm with its lead drug candidate, lenzilumab, today reported financial results for the year ended December 31, 2021, and announced corporate objectives for 2022.

Key Points: 
  • Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm with its lead drug candidate, lenzilumab, today reported financial results for the year ended December 31, 2021, and announced corporate objectives for 2022.
  • Net cash used in operating activities, net of balance sheet changes, was $184.0 million for the year ended December 31, 2021.
  • Subsequent to December 31, 2021, the company raised net proceeds of approximately $3.7 million under its At-the-Market offering program.
  • A summary of key financial highlights as of and for the years ended December 31, 2021 and 2020 is as follows ($ in thousands):
    Three Months Ended December 31,

Humanigen and Cenexi Announce Collaboration to Manufacture Lenzilumab in France

Retrieved on: 
수요일, 2월 9, 2022
Other Manufacturing, Genetics, Clinical Trials, Manufacturing, Stem Cells, Biotechnology, Other Health, Health, Pharmaceutical, Granulocyte-macrophage colony-stimulating factor, Pandemic, Forward-looking statement, Lenzilumab, Chemokine, Conditional, Twitter, Rheumatoid arthritis, GM-CSF, Union, AAP, Hérouville-Saint-Clair, NIH, United States security assistance to the Palestinian National Authority, Technology, Knowledge, Patient, Risk, Graft-versus-host disease, CDMO, SEC, Saint Clair, Government of France, Goal, Accelerated approval (FDA), Emergency Use Authorization, Nasdaq, Partnership, LinkedIn, Judgement, AD, Fontenay-sous-Bois, COVID-19, Pharmaceutical industry, Video game, Facebook, Humanigen, Cenexi, HUMANIGEN, CENEXI

Humanigen and Cenexi will enter into discussions to potentially expand the agreement to other services Cenexi offers.

Key Points: 
  • Humanigen and Cenexi will enter into discussions to potentially expand the agreement to other services Cenexi offers.
  • Humanigen plans to include the Cenexi Normandy site in certain of its future regulatory filings for lenzilumab for COVID-19 and other indications.
  • In addition, Cenexi will assist Humanigen as it seeks an advanced purchase agreement for lenzilumab in France.
  • The goal of the collaboration with Cenexi is to further our efforts to establish a supply of lenzilumab made in Europe, commented Cameron Durrant, chief executive officer of Humanigen.

Lenzilumab Treatment Response in Hospitalized COVID-19 Patients Correlates with C-Reactive Protein Levels

Retrieved on: 
월요일, 1월 3, 2022
Health, Infectious Diseases, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, CRP, MedRxiv, COVID-19, Granulocyte-macrophage colony-stimulating factor, Manuscript, Disease, GM, HIV disease progression rates, Patient, GM-CSF, Nasdaq, Pharmaceutical industry, the LIVE-AIR, Phase 3 Study of Lenzilumab, Lenzilumab, THE LIVE-AIR, PHASE 3 STUDY OF LENZILUMAB, LENZILUMAB

The results indicate the greatest clinical benefit of lenzilumab treatment may be achieved in hospitalized COVID-19 patients with lower baseline CRP levels, which typically occur earlier in the progression of the disease.

Key Points: 
  • The results indicate the greatest clinical benefit of lenzilumab treatment may be achieved in hospitalized COVID-19 patients with lower baseline CRP levels, which typically occur earlier in the progression of the disease.
  • This analysis and publication provide evidence that a biomarker-driven approach utilizing baseline CRP levels to guide therapeutic intervention and patient selection may improve outcomes in patients hospitalized with COVID-19.
  • Lenzilumab binds to and neutralizes GM-CSF, consequently improving outcomes for patients hospitalized with COVID-19.
  • Humanigens Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent consequences of a full-blown cytokine storm in hospitalized patients with COVID-19.

The Lancet Respiratory Medicine Publishes Peer-Reviewed Paper and Independent Expert Commentary on Positive Phase 3 Lenzilumab Results

Retrieved on: 
수요일, 12월 1, 2021
Research, Medical Devices, Infectious Diseases, Hospitals, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, the LIVE-AIR, Phase 3 Study of Lenzilumab, Lenzilumab, Humanigen, THE LIVE-AIR, PHASE 3 STUDY OF LENZILUMAB, LENZILUMAB, HUMANIGEN

The results describe the positive impact lenzilumab has on improving survival without the need for invasive mechanical ventilation in COVID-19 patients upon hospitalization, said Cameron Durrant, Chairman and CEO, Humanigen.

Key Points: 
  • The results describe the positive impact lenzilumab has on improving survival without the need for invasive mechanical ventilation in COVID-19 patients upon hospitalization, said Cameron Durrant, Chairman and CEO, Humanigen.
  • The need is great for more therapies for newly hospitalized patients prior to respiratory failure to reduce mortality or mechanical ventilation.
  • Agents that interfere with its actions have high plausibility for benefit, not just in COVID-19, but in other acute inflammatory conditions,1 noted the commentary.
  • Lenzilumab in hospitalised patients with COVID-19 pneumonia (LIVE-AIR): a phase 3, randomised, placebo-controlled trial.

NIH Advances ACTIV-5/BET-B Trial Evaluating Lenzilumab from a Phase 2 Exploratory Study to a Phase 2/3 Study for the Treatment of COVID-19

Retrieved on: 
금요일, 7월 30, 2021
Biotechnology, Infectious diseases, Health, Pharmaceutical, Clinical trials, Clinical research, Monoclonal antibodies, Health, Medicine, Lenzilumab, Placebo, National Institutes of Health, Activ, Chevrolet Spin, ACTIV-5/BET-B, Lenzilumab, Humanigen, ACTIV-5/BET-B, LENZILUMAB, HUMANIGEN

We appreciate the close collaboration with NIH on this important study, said Adrian Kilcoyne, MD, Chief Medical Officer, Humanigen.

Key Points: 
  • We appreciate the close collaboration with NIH on this important study, said Adrian Kilcoyne, MD, Chief Medical Officer, Humanigen.
  • The ACTIV-5/BET-B study design has been adapted to align with the design of LIVE-AIR and may help support a future BLA for lenzilumab.
  • ACTIV-5/BET-B may provide prospective validation for lenzilumab in the treatment of COVID-19, said Cameron Durrant, MD, Chief Executive Officer, Humanigen.
  • The primary endpoint was the difference between lenzilumab treatment and placebo treatment in SWOV through 28 days following treatment.

Humanigen’s Partner in South Korea Receives Ministry of Food and Drug Safety (MFDS) Approval to Conduct Phase 1 Study of Lenzilumab

Retrieved on: 
목요일, 7월 22, 2021
Biotechnology, Infectious diseases, Health, Pharmaceutical, Clinical trials, Medical specialties, Health, Occupational safety and health, Cytokine storm, Endocrine system, Immunology, COVID-19, Lenzilumab, Humanigen, Inc., KPM Tech Co., Ltd/Telcon RF Pharmaceutical, Inc., HUMANIGEN, INC., KPM TECH CO., LTD/TELCON RF PHARMACEUTICAL, INC.

Support for conditional approval would be based on data from this phase 1 study and the existing data from Humanigens Phase 3 LIVE-AIR study.

Key Points: 
  • Support for conditional approval would be based on data from this phase 1 study and the existing data from Humanigens Phase 3 LIVE-AIR study.
  • We are hopeful that these data, alongside data generated in Korea by our partners, will allow for the use of lenzilumab in South Korea.
  • Like many countries, South Korea is experiencing rising number of COVID-19 cases, particularly due to the spread of the Delta variant.
  • Humanigens Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent consequences of a full-blown cytokine storm in hospitalized patients with COVID-19.

UK’s MHRA accepts Humanigen’s submission of Lenzilumab for Marketing Authorization in COVID-19 for expedited rolling review

Retrieved on: 
금요일, 7월 9, 2021
Health, Infectious diseases, Hospitals, General Health, Pharmaceutical, Biotechnology, Medical specialties, Health, Canary Wharf, Department of Health and Social Care, Medicines and Healthcare products Regulatory Agency, Monoclonal antibodies, COVID-19, MHRA, Cytokine storm, Lenzilumab

Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), today announced its submission for Marketing Authorization for lenzilumab in COVID-19, begun in June 2021, has been accepted by the United Kingdoms (UKs) Medicines and Healthcare Products Regulatory Agency (MHRA) for expedited COVID-related rolling review, with assessment expected to occur more rapidly than a standard rolling review.

Key Points: 
  • Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), today announced its submission for Marketing Authorization for lenzilumab in COVID-19, begun in June 2021, has been accepted by the United Kingdoms (UKs) Medicines and Healthcare Products Regulatory Agency (MHRA) for expedited COVID-related rolling review, with assessment expected to occur more rapidly than a standard rolling review.
  • We are grateful this submission will receive expedited consideration by MHRA, said Cameron Durrant, CEO of Humanigen.
  • Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm.
  • Humanigens Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent consequences of a full-blown cytokine storm in hospitalized patients with COVID-19.