HUMANIGEN, INC.


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

Humanigen to Present and Participate at Multiple Upcoming Investor and Industry Conferences

Retrieved on: 
목요일, 2월 11, 2021

Management will also participate in a Fireside Chat with Cantor Fitzgerald Analyst Louise Chen on February 26, 2021.

Key Points: 
  • Management will also participate in a Fireside Chat with Cantor Fitzgerald Analyst Louise Chen on February 26, 2021.
  • 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.

Humanigen and Avid Bioservices Enter Into cGMP Manufacturing Agreement for COVID-19 Therapeutic Candidate Lenzilumab in Support of Potential EUA Filing

Retrieved on: 
수요일, 2월 3, 2021

Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP) (Avid) and Humanigen, Inc. (NASDAQ:HGEN) (Humanigen) today announced that they have entered into a manufacturing services agreement to expand production capacity for lenzilumab, Humanigens therapeutic candidate in development for COVID-19.

Key Points: 
  • Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP) (Avid) and Humanigen, Inc. (NASDAQ:HGEN) (Humanigen) today announced that they have entered into a manufacturing services agreement to expand production capacity for lenzilumab, Humanigens therapeutic candidate in development for COVID-19.
  • This collaboration enhances commercial production efforts for lenzilumab in advance of potential filings for emergency use authorization (EUA) and subsequent Biologics License Application (BLA) later this year.
  • Lenzilumab is an exciting COVID-19 therapeutic candidate and the type of complex biologic for which Avid possesses decades of manufacturing success.
  • Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical drug substances derived from mammalian cell culture.

Humanigen Completes Enrollment in Phase 3 Study of Lenzilumab in Hospitalized Patients with COVID-19

Retrieved on: 
금요일, 1월 29, 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 it has completed enrollment for its pivotal phase 3 study of lenzilumab for 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 drug candidate lenzilumab, today announced it has completed enrollment for its pivotal phase 3 study of lenzilumab for COVID-19.
  • Completing enrollment in this Phase 3 study is a significant milestone in the clinical development of lenzilumab, said Cameron Durrant, MD, MBA, chief executive officer of Humanigen.
  • We are grateful to the trial participants, their families, investigators and healthcare professionals for their contributions and partnership in continuing to advance the development of lenzilumab.
  • Data showed that almost 90 percent of hospitalized patients with COVID-19 are at risk of this immune hyper-response.

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: 
수요일, 1월 27, 2021

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: 
월요일, 1월 25, 2021

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 Announces the Addition of BARDA and Expansion of CRADA with the U.S. Government to Develop Lenzilumab for COVID-19

Retrieved on: 
금요일, 1월 22, 2021

The agreement supports development of lenzilumab in advance of a potential Emergency Use Authorization (EUA) for COVID-19.

Key Points: 
  • The agreement supports development of lenzilumab in advance of a potential Emergency Use Authorization (EUA) for COVID-19.
  • The amended CRADA, now co-signed by BARDA, provides Humanigen with access to manufacturing capacity reserved by BARDA for fill-finish product to accelerate the drug product manufacturing of lenzilumab.
  • Lenzilumab is currently in a Phase 3 clinical trial evaluating patients hospitalized with COVID-19.
  • It has been an honor to have the integrated expert team at BARDA prioritize lenzilumab research and development during this critical time, said Cameron Durrant, MD, MBA, chief executive officer of Humanigen.

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

Retrieved on: 
일요일, 1월 10, 2021

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.

Humanigen to Present at Multiple Upcoming Investor Conferences

Retrieved on: 
화요일, 1월 5, 2021

We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection.

Key Points: 
  • We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection.
  • The companys 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.
  • The company 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.
  • You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release.

Humanigen Secures U.S. Patent for Lenzilumab in Preventing Cytokine Storm and Neurotoxicity Related to CAR-T Cell Therapy

Retrieved on: 
월요일, 12월 28, 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 United States Patent and Trademark Office has issued a patent to the Company for the use of lenzilumab in prevention or treatment of cytokine storm and neurotoxicity in patients undergoing chimeric antigen receptor T (CAR-T) cell therapy.

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 United States Patent and Trademark Office has issued a patent to the Company for the use of lenzilumab in prevention or treatment of cytokine storm and neurotoxicity in patients undergoing chimeric antigen receptor T (CAR-T) cell therapy.
  • The patent covers the use of lenzilumab to prevent or treat cytokine release syndrome (CRS), neurotoxicity and otherwise inhibit or reduce incidence or severity of CAR-T-related toxicities in patients undergoing CAR-T cell therapy.
  • This patent underscores Humanigens pioneering approach to neutralizing GM-CSF with lenzilumab and the value of our robust pipeline across the many disease areas where cytokine storm plays a critical role, including COVID-19 and acute graft-versus-host disease.
  • The patent, titled Methods of Treating Immunotherapy-Related Toxicity Using a GM-CSF Antagonist, was issued on December 22, 2020 as U.S. Patent No.

Humanigen to Present at J.P. Morgan Healthcare Conference

Retrieved on: 
목요일, 12월 17, 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 and host meetings with investors and potential partners at the J.P. Morgan Healthcare Conference, held virtually from January 11 to 14, 2021.

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 and host meetings with investors and potential partners at the J.P. Morgan Healthcare Conference, held virtually from January 11 to 14, 2021.
  • We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection.
  • Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements.
  • You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release.