Humanigen, Inc.

Humanigen Announces Abstracts Accepted for the British Thoracic Society Winter Meeting 2021

Retrieved on: 
Monday, November 22, 2021
Health, Infectious Diseases, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Patient, 2021 Essex County Council election, Government, British Thoracic Society, CEO, C-reactive protein, Death, MD, CRP, Pulmonary alveolar proteinosis, COVID-19, Nasdaq, Chief executive officer, Incidence, Nursing, United Kingdom, Randomness, Pharmaceutical industry, ISARIC Coronavirus Clinical Characterisation Consortium (4C) Mortality Score, Humanigen, Inc., ISARIC CORONAVIRUS CLINICAL CHARACTERISATION CONSORTIUM (4C) MORTALITY SCORE, HUMANIGEN, INC.

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 announced three abstracts pertaining to the potential use of lenzilumab in hospitalized COVID-19 patients will be presented at the British Thoracic Society Winter 2021 Meeting taking place Nov. 24-26, 2021.

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 announced three abstracts pertaining to the potential use of lenzilumab in hospitalized COVID-19 patients will be presented at the British Thoracic Society Winter 2021 Meeting taking place Nov. 24-26, 2021.
  • The society counts more than 4,000 members comprised of doctors, nurses, respiratory physiotherapists, scientists, and other professionals with a respiratory interest.
  • The study also demonstrated significant improvement in SWOV for the predefined subgroup of subjects who received both corticosteroids and remdesivir (HR: 1.92; nominal p=0.0067).
  • Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), is a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm.

First Patient Dosed in Phase 2 Precision Medicine Study of Lenzilumab in Patients with Chronic Myelomonocytic Leukemia (CMML)

Retrieved on: 
Tuesday, October 26, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, CBL, Twitter, Lymphatic system, Chemokine, Clinical trial, COVID-19, Inflammation, Health, Rheumatoid arthritis, Padrón, Blood, Incidence, Granulocyte-macrophage colony-stimulating factor, Warner Sallman, Judgement, National Health, RAS, Leukemia, Chronic myelomonocytic leukemia, Survival, Risk, GM-CSF, SAHMRI, Goal, III, Hypersensitivity, SEC, Medical Research Council, Government, Precision medicine, Medical Research Future Fund, Medicare, CEO, Nasdaq, Acute leukemia, Patient, Mutation, South Australian Health and Medical Research Institute, University, LinkedIn, Geography, Cancer, Hematology, Knowledge, NRAS, TET2, National Health and Medical Research Council, Azacitidine, Forward-looking statement, GM, Associate, KRAS, Progression-free survival, Pharmaceutical industry, Vaccine, Risk management, PREACH-M, Humanigen, Inc., SAHMRI, PREACH-M, HUMANIGEN, INC., SAHMRI

The PREACH-M trial is designed to focus on Chronic Myelomonocytic Leukemia (CMML) patients who carry mutations believed to drive the leukemia.

Key Points: 
  • The PREACH-M trial is designed to focus on Chronic Myelomonocytic Leukemia (CMML) patients who carry mutations believed to drive the leukemia.
  • Patients with RAS pathway mutations such as KRAS, NRAS, or CBL, will be enrolled in the lenzilumab and azacitidine arm.
  • 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.
  • A phase 1 study of lenzilumab, a humaneered recombinant anti-human granulocyte-macrophage colony- stimulating factor (anti-hGM-CSF) antibody, for chronic myelomonocytic leukemia (CMML).

Lenzilumab Treatment May Provide Enhanced Likelihood of Survival Without Ventilation in Hospitalized Black and African-American COVID-19 Patients

Retrieved on: 
Wednesday, August 4, 2021
Health, Infectious Diseases, Hospitals, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Clinical medicine, Medical specialties, Medicine, Biomarkers, C-reactive protein, Chemical pathology, CAMP receptor protein, CRP Group, the LIVE-AIR, Phase 3 Study of Lenzilumab, Humanigen, Inc., THE LIVE-AIR, PHASE 3 STUDY OF LENZILUMAB, HUMANIGEN, INC.

In the overall population with CRP

Key Points: 
  • In the overall population with CRP
  • LIVE-AIR Phase 3 study met its primary endpoint of survival without ventilation demonstrating a 1.54-fold improvement overall and trended to a 2.68-fold improvement in Black and African-American patients.
  • This study was a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial for the treatment and prevention of serious and potentially fatal outcomes in patients hospitalized with COVID-19 pneumonia.
  • The primary endpoint was the difference between lenzilumab treatment and placebo treatment in SWOV through day 28 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: 
Thursday, July 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.

Humanigen and Chime Biologics Enter Into Manufacturing Agreement for COVID-19 Therapeutic Candidate Lenzilumab

Retrieved on: 
Monday, May 17, 2021
Science, Biotechnology, Research, Pharmaceutical, Other Manufacturing, Health, Infectious diseases, Manufacturing, Life sciences, Biotechnology, Health sciences, ISO 45001, Occupational safety and health, Biopharmaceutical, Chime Biologics, Humanigen, Inc., CHIME BIOLOGICS, HUMANIGEN, INC.

The cell culture capacity at the facility is 24,000L with planned expansion to 140,000L and Chime would be willing to commit at least 56,000L for Humanigen manufacture annually.

Key Points: 
  • The cell culture capacity at the facility is 24,000L with planned expansion to 140,000L and Chime would be willing to commit at least 56,000L for Humanigen manufacture annually.
  • Technical transfer work has already begun, and commercial product is planned to be available in 2022.\n\xe2\x80\x9cWe are pleased to have been selected by Humanigen as a manufacturing partner for ex-US supply of lenzilumab.
  • Since 2013, Chime Biologics has developed and produced more than 30 products and supplied to over 20 countries from its latest generation single use facility.
  • Chime Biologics is ISO 14001:2015 and ISO 45001:2018 certified, and is committed to uphold the highest degree of integrity.

Humanigen Reports Positive Phase 3 Topline Results Demonstrating That Lenzilumab™ Improves Survival Without Need for Mechanical Ventilation in Hospitalized Patients With COVID-19

Retrieved on: 
Monday, March 29, 2021
Infectious diseases, Hospitals, Genetics, Clinical trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Clinical trials, Clinical research, Medical statistics, Clinical endpoint, Medical research, Health, the Lenzilumab Phase 3 Study, Humanigen, Inc.

The study achieved its primary endpoint of ventilator-free survival measured through day 28 following treatment (HR: 1.54; 95%CI: 1.03-2.33, p=0.0365).

Key Points: 
  • The study achieved its primary endpoint of ventilator-free survival measured through day 28 following treatment (HR: 1.54; 95%CI: 1.03-2.33, p=0.0365).
  • In this study, lenzilumab appeared to be safe and well-tolerated; no new SAEs were identified, and none were attributed to lenzilumab.
  • The dosing regimen used in this study was specifically designed for hospitalized patients with COVID-19 pneumonia as a potential foundational therapy.
  • The primary endpoint was the difference between lenzilumab treatment and placebo treatment in ventilator-free survival through 28 days following treatment.

Humanigen to Host Conference Call to Report Phase 3 Topline Results of LenzilumabTM in Patients Hospitalized With COVID-19

Retrieved on: 
Monday, March 29, 2021
Research, Infectious diseases, Clinical trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Medical specialties, Health, Clinical medicine, Immune system disorders, Monoclonal antibodies, Pneumonia, EMR1, Placebo-controlled study, COVID-19, Cytokine release syndrome, Lenzilumab, the Lenzilumab Phase 3 Study, Humanigen, Inc.

Details for the upcoming conference are below:

Key Points: 
  • Details for the upcoming conference are below:
    This study was a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial for the treatment and prevention of serious and potentially fatal outcomes in patients who were hospitalized with COVID-19 pneumonia.
  • The primary endpoint was the difference between lenzilumab treatment and placebo treatment in ventilator-free survival through 28 days following treatment.
  • Humanigens immediate focus is to prevent or minimize cytokine release syndrome that precedes severe lung dysfunction in hospitalized and hypoxic patients with COVID-19 pneumonia.
  • In addition, Humanigen is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders.

Ajinomoto Bio-Pharma Services and Humanigen Expand Manufacturing Agreement to Support Fill Finish for Investigational COVID-19 Therapeutic, Lenzilumab, Nearing Completion of Phase 3 Study

Retrieved on: 
Wednesday, January 27, 2021
Infectious diseases, Biotechnology, Pharmaceutical, Health, Branches of biology, Cytokines, Cell biology, Granulocyte-macrophage colony-stimulating factor, Lenzilumab, Ajinomoto, Coronavirus disease, Emergency Use Authorization, Macrophage colony-stimulating factor, Ajinomoto Bio-Pharma Services, Humanigen, Inc.

Humanigen is actively enrolling patients in a Phase 3 study in the U.S. and Brazil and preparing for a potential COVID-19 Emergency Use Authorization (EUA) for lenzilumab.

Key Points: 
  • Humanigen is actively enrolling patients in a Phase 3 study in the U.S. and Brazil and preparing for a potential COVID-19 Emergency Use Authorization (EUA) for lenzilumab.
  • We are very pleased to be working with Aji Bio-Pharma for the fill finish production of lenzilumab, said Cameron Durrant, MD, MBA, Chief Executive Officer of Humanigen.
  • Ajinomoto Bio-Pharma Services is dedicated to providing a high level of quality and service to meet our clients needs.
  • Humanigen believes that its GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection.

Humanigen and Emergent BioSolutions Announce Contract Development and Manufacturing Agreement for Phase 3 COVID-19 Therapeutic Candidate Lenzilumab™

Retrieved on: 
Monday, January 25, 2021
Infectious diseases, Biotechnology, Pharmaceutical, Health, Life sciences, Pharmaceutical industry, Health sciences, Emergent BioSolutions, Biotechnology, Biologics license application, Contract manufacturing organization, Emergent, Biopharmaceutical, Emergent BioSolutions, Humanigen, Inc.

The parties intend to negotiate a commercial manufacturing services agreement that could include future fill batches for a biologics license application (BLA).

Key Points: 
  • The parties intend to negotiate a commercial manufacturing services agreement that could include future fill batches for a biologics license application (BLA).
  • Partnering with leading CDMOs like Emergent BioSolutions to help us build out our manufacturing capacity is a cornerstone to that strategy, said Cameron Durrant, MD, MBA, chief executive officer of Humanigen.
  • This agreement marks Emergents seventh CDMO collaboration with government and industry partners working to deliver COVID-19 vaccine and therapeutic solutions.
  • Through Emergents specialty products and contract development and manufacturing services, Emergent is dedicated to providing solutions that address public health threats.

Humanigen and EVERSANA Announce Partnership to Support the Launch and Commercialization of Lenzilumab for the Treatment of COVID-19

Retrieved on: 
Sunday, January 10, 2021
Infectious diseases, Pharmaceutical, Health, Clinical trials, Articles, Management education, Master of Business Administration, Forward-looking statement, Eua, Coronavirus disease, Human activities, Academic disciplines, Humanigen, Inc., EVERSANA™

The agreement with EVERSANA builds on the commercial preparation and lenzilumab launch planning Humanigen has been conducting over the last several months.

Key Points: 
  • The agreement with EVERSANA builds on the commercial preparation and lenzilumab launch planning Humanigen has been conducting over the last several months.
  • EVERSANA shares our tireless commitment to patients, said Cameron Durrant, MD, MBA, chief executive officer of Humanigen.
  • Weve matched our dedication to research and development in COVID-19 with a proven commercialization partner to ensure lenzilumab will reach patients quickly and efficiently following a potential EUA.
  • You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release.