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Lenzilumab,
Granulocyte-macrophage colony-stimulating factor,
COVID-19,
Medical specialties,
Drugs The recommended Phase 2 dose was determined to be 1,800 mg.\nIn the six study patients, the ORR was 83% (n=5) which included four complete responses (CR).
Key Points:
- The recommended Phase 2 dose was determined to be 1,800 mg.\nIn the six study patients, the ORR was 83% (n=5) which included four complete responses (CR).
- At the recommended Phase 2 dose (cohort 2), ORR was 100% (n=3) and the toxicity-free CR (CRS and NT
- There were no adverse events attributed to lenzilumab across the study.\nInflammatory markers were correlated with reduced rates of CRS and NT.
- Humanigen believes that its GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection.
Oncology,
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Health,
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Biotechnology,
Tumor,
Tumor microenvironment,
Oncology,
Clinical medicine,
Medicine,
Health In the study, ifabotuzumab demonstrated highly sensitive, specific, and reproducible targeting of the tumor and tumor microenvironment in all patients.
Key Points:
- In the study, ifabotuzumab demonstrated highly sensitive, specific, and reproducible targeting of the tumor and tumor microenvironment in all patients.
- The Phase 1 study primarily sought to determine the safety and recommended Phase 2 dose of ifabotuzumab in patients with GBM, the most frequent and lethal primary brain neoplasm, with 5-year survival rates of 10%.
- The positive results of the Phase 1 study, which show ifabotuzumab to be well-tolerated and effective at targeting the EphA3 receptor, support further investigation into ifabotuzumabs effect on other solid tumors in a Phase 2 study.
- We are pleased to announce the positive Phase 1 results of ifabotuzumab in patients with gliobastoma multiforme, said Cameron Durrant, MD, MBA, Chief Executive Officer of Humanigen.
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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.
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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.
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Annual general meeting 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, announced today that its board of directors has scheduled the corporation's 2021 Annual Meeting of Shareholders (the Meeting) for June 17, 2021 in a virtual-only format via the internet.
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, announced today that its board of directors has scheduled the corporation's 2021 Annual Meeting of Shareholders (the Meeting) for June 17, 2021 in a virtual-only format via the internet.
- The record date for shareholders to vote at the meeting is April 21, 2021.
- Additional information confirming how shareholders may vote before or during the Meeting, as well as the time of the virtual Meeting and how to access it as a shareholder, will be included in the companys proxy statement to be separately provided to shareholders.
- In order to streamline the virtual meeting process, the company strongly encourages shareholders to vote in advance of the Meeting.
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Research,
Science,
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DC Comics characters,
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Fantasy comics,
Hercules Under the terms of the facility, Hercules will provide Humanigen up to $80 million of secured debt financing.
Key Points:
- Under the terms of the facility, Hercules will provide Humanigen up to $80 million of secured debt financing.
- The facility consists of a $25 million initial term loan, with up to an additional $55.0 million available for future draws subject to achievement of future milestones and satisfaction of other conditions.
- The facility provides for an interest-only period and the four-year term is extendable under certain conditions.
- "Hercules is excited to be partnering with Humanigen as it advances lenzilumab for COVID-19 and other indications.
The study fully enrolled 520 patients, with topline data anticipated to be released before the end of March 2021.
Key Points:
- The study fully enrolled 520 patients, with topline data anticipated to be released before the end of March 2021.
- The increase in SG&A expense is primarily due to the items noted above for the year ended December 31, 2020.
- During 2020, the company raised $139.8 million in net proceeds from its private placement in June and its underwritten public offering in September 2020.
- A summary of key financial highlights as of and for the years ended December 31, 2020 and 2019 is as follows ($ in thousands):
Twelve Months Ended December 31,
Professional services,
Health,
Infectious diseases,
Finance,
Clinical trials,
Pharmaceutical,
Biotechnology,
Branches of biology,
Cell biology,
Cytokines,
Granulocyte-macrophage colony-stimulating factor,
EMR1,
Macrophage colony-stimulating factor,
Coronavirus disease Humanigen believes that its GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection.
Key Points:
- 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 is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity.
- 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.
- For more information, visit www.humanigen.com and follow Humanigen on LinkedIn , Twitter and Facebook .
Oncology,
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Infectious diseases,
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Cytokines,
Granulocyte-macrophage colony-stimulating factor,
EMR1,
Colony-stimulating factor,
Macrophage colony-stimulating factor,
Macrophage These two patents expand Humanigens patent portfolio and demonstrate the value of the companys pioneering approach to neutralizing granulocyte-macrophage colony-stimulating factor (GM-CSF).
Key Points:
- These two patents expand Humanigens patent portfolio and demonstrate the value of the companys pioneering approach to neutralizing granulocyte-macrophage colony-stimulating factor (GM-CSF).
- Together, these patents continue to solidify Humanigens robust intellectual property portfolio which includes over 100 issued patents and over 50 patent applications.
- Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms.
- 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.
Biotechnology,
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Health,
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Clinical medicine,
Immunology,
Cytokines,
Granulocyte-macrophage colony-stimulating factor,
Cytokine release syndrome,
Coronavirus disease,
Macrophage colony-stimulating factor,
EMR1,
Cytokine,
Acute respiratory distress syndrome Humanigen believes that its GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection.
Key Points:
- Humanigen believes that its GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection.
- Humanigens immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection.
- Humanigen is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity.
- 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.
