HUMANIGEN, INC.


Associated tags: Health, Biotechnology, COVID-19, Pharmaceutical, Clinical Trials, Pharmaceutical industry, Research, Patient

Humanigen Announces Completion of Enrollment in Phase 1 Study of Ifabotuzumab in Glioblastoma Multiforme

Retrieved on: 
Thursday, December 17, 2020

(NASDAQ: HGEN) (Humanigen), a clinical stage biopharmaceutical company developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases, today announced completing enrollment in its Phase 1 bioimaging study of ifabotuzumab in patients with recurrent glioblastoma multiforme (GBM).

Key Points: 
  • (NASDAQ: HGEN) (Humanigen), a clinical stage biopharmaceutical company developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases, today announced completing enrollment in its Phase 1 bioimaging study of ifabotuzumab in patients with recurrent glioblastoma multiforme (GBM).
  • Results from the study, being conducted at the Olivia Newton-John Cancer Research Institute in Heidelberg, Victoria, Australia, are expected in the first half of 2021.
  • Ifabotuzumab represents an important part of our immuno-oncology arsenal as we advance our pipeline to target a wide-range of cancers.
  • Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial.

Humanigen to Present at Upcoming Investor Conferences

Retrieved on: 
Monday, December 14, 2020

(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 that the Companys management will present at the PNC Bank & Solebury Trout COVID Webinar and LD Micro Investor Conference on December 15, 2020.

Key Points: 
  • (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 that the Companys management will present at the PNC Bank & Solebury Trout COVID Webinar and LD Micro Investor Conference on December 15, 2020.
  • Details for the upcoming virtual investor conferences are below:
    PNC Bank & Solebury Trout COVID Webinar (December 15, 2020)
    LD Micro Investor Conference (December 14-15, 2020)
    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.
  • We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection.
  • You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release.

Humanigen Australia Proprietary Limited Established to Facilitate Asia-Pacific Growth Plans

Retrieved on: 
Monday, November 23, 2020

(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 the establishment of Humanigen Australia Proprietary Limited (Humanigen Australia Pty Ltd), through which Humanigen intends to assess potential partnering opportunities, facilitate clinical development programs, and conduct other corporate and business development activities in the Asia-Pacific region.

Key Points: 
  • (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 the establishment of Humanigen Australia Proprietary Limited (Humanigen Australia Pty Ltd), through which Humanigen intends to assess potential partnering opportunities, facilitate clinical development programs, and conduct other corporate and business development activities in the Asia-Pacific region.
  • The study is supported by a grant from the Australian Government's Medical Research Future Fund.
  • In addition, the company 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.
  • Suboptimal response rates to hypomethylating agent therapy in chronic myelomonocytic leukemia; a single institutional study of 121 patients.

Humanigen Reports Third Quarter and Nine Months Ended September 30, 2020 Financial Results

Retrieved on: 
Wednesday, November 11, 2020

Completed an underwritten public offering and uplisted to the Nasdaq Capital Market in September 2020.

Key Points: 
  • Completed an underwritten public offering and uplisted to the Nasdaq Capital Market in September 2020.
  • Nine months ended September 30, 2020 Financial Results
    Net loss for the nine months ended September 30, 2020 was $57.2 million or $1.79 per share as compared to $8.3 million or $0.37 per share for the first nine months of 2019.
  • Net cash used in operating activities, net of balance sheet changes, was $23.0 million for the third quarter of 2020.
  • A summary of key financial highlights as of and for the periods ended September 30, 2020 and 2019 is as follows ($ in thousands):
    Three Months Ended September 30,
    Nine Months Ended September 30,

Humanigen Announces Positive Interim Phase 3 Data of Lenzilumab™ in Patients Hospitalized with COVID-19

Retrieved on: 
Friday, November 6, 2020

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 investigational treatment lenzilumab, today announced positive interim Phase 3 data of lenzilumab in patients hospitalized with COVID-19.

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 investigational treatment lenzilumab, today announced positive interim Phase 3 data of lenzilumab in patients hospitalized with COVID-19.
  • View the full release here: https://www.businesswire.com/news/home/20201106005112/en/
    These interim data demonstrate the potential of lenzilumab as a frontline treatment option for patients hospitalized with COVID-19, said Cameron Durrant, MD, MBA, chief executive officer of Humanigen.
  • We are encouraged by these data and the clinically meaningful impact that lenzilumab may have for patients with COVID-19 over and above remdesivir and/or steroids.
  • The Phase 3 trial evaluating patients hospitalized with COVID-19 is enrolling at sites across the U.S. and Latin America.

Humanigen Announces Cooperative Research and Development Agreement with the Department of Defense to Develop Lenzilumab for COVID-19

Retrieved on: 
Friday, November 6, 2020

The CRADA aims to support the ongoing lenzilumab Phase 3 clinical trials, focusing on efficiently generating EUA and BLA submissions.

Key Points: 
  • The CRADA aims to support the ongoing lenzilumab Phase 3 clinical trials, focusing on efficiently generating EUA and BLA submissions.
  • In addition to providing access under EUA, a goal of the CRADA is to ensure lenzilumab receives the benefits provided by Public Law 115-92 .
  • We have been working tirelessly to advance lenzilumab for COVID-19 and are excited to have the integrated expert team at OWS prioritize lenzilumab research and development during this critical time.
  • You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release.

Humanigen Announces ZUMA-19 Abstract Accepted for Presentation at American Society of Hematology 2020 Annual Meeting

Retrieved on: 
Wednesday, November 4, 2020

ZUMA-19 is a joint Humanigen/Kite, a Gilead Company, clinical study that is being conducted as part of a clinical collaboration in the US.

Key Points: 
  • ZUMA-19 is a joint Humanigen/Kite, a Gilead Company, clinical study that is being conducted as part of a clinical collaboration in the US.
  • The ongoing ZUMA-19 Phase 1b/2 multicenter study is evaluating lenzilumab in adults with relapsed/refractory large B-cell lymphoma (R/R LBCL) who are receiving CAR-T cell therapy with axicabtagene ciloleucel.
  • 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.
  • You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release.

Humanigen Executes Licensing Agreement for Lenzilumab™ in COVID-19 with KPM Tech/Telcon RF Pharmaceutical for South Korea and the Philippines

Retrieved on: 
Tuesday, November 3, 2020

Telcon is an affiliate of KPM Tech and both companies recently invested in the Humanigen June 2020 PIPE offering.

Key Points: 
  • Telcon is an affiliate of KPM Tech and both companies recently invested in the Humanigen June 2020 PIPE offering.
  • Lenzilumab has a significant part to play in the treatment of patients in the pandemic and beyond.
  • We are honored to be selected to develop and potentially launch lenzilumab in South Korea and the Philippines.
  • Telcon and KPM Tech will be responsible for gaining regulatory approval and subsequent commercialization of lenzilumab in its territories.

Humanigen Announces First Patient Dosed at MedStar Washington Hospital Center in Phase 3 Clinical Study of Lenzilumab in COVID-19

Retrieved on: 
Friday, October 30, 2020

Humanigen, Inc. (HGEN) (Humanigen), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm with lenzilumab, today announced that MedStar Washington Hospital Center in Washington, D.C. treated its first COVID-19 patient with lenzilumab.

Key Points: 
  • Humanigen, Inc. (HGEN) (Humanigen), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm with lenzilumab, today announced that MedStar Washington Hospital Center in Washington, D.C. treated its first COVID-19 patient with lenzilumab.
  • The primary goal of this Phase 3 randomized, double-blind, multicenter, placebo-controlled clinical trial is to determine if lenzilumab can help hospitalized patients with COVID-19 recover faster.
  • MedStar Washington Hospital Center is one of 18 sites in the U.S. approved to enroll eligible patients to study lenzilumab, designed specifically to stop this storm .
  • Eligible patients can participate in this trial while also receiving other standard-of-care therapies as recommended by their treating physician.

Humanigen Announces First Patient Dosed in NIH ACTIV-5/Big Effect Trial Evaluating Lenzilumab™ for COVID-19

Retrieved on: 
Thursday, October 29, 2020

Lenzilumab is the Companys lead product candidate and proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody designed to optimize antibody properties.

Key Points: 
  • Lenzilumab is the Companys lead product candidate and proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody designed to optimize antibody properties.
  • The adaptive, randomized, double-blind placebo-controlled trial evaluating lenzilumab with remdesivir will include up to 200 patients across as many as 40 treatment centers in the U.S.
  • Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration.
  • You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release.