HUMANIGEN, INC.

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

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월요일, 11월 22, 2021

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)

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화요일, 10월 26, 2021

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

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수요일, 8월 4, 2021

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

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목요일, 7월 22, 2021

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

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월요일, 5월 17, 2021

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.