Biotechnology,
Infectious diseases,
Health,
Pharmaceutical,
Clinical trials,
Emergency Use Authorization,
Food and Drug Administration,
Health,
Medicine,
COVID-19 vaccines,
Clinical trials,
BioNTech This application follows Humanigens submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA).
Key Points:
- This application follows Humanigens submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA).
- Despite vaccine uptake, there continues to be a need for proven therapies that are variant-agnostic for patients that remain at risk of COVID-19.
- Now, with applications in the US and in the UK, we feel we can help tackle this global challenge.
- We are pleased to be able to submit this application through Humanigen Ltd., our wholly-owned UK subsidiary.
Ken also has experience working with multiple biopharmaceutical companies at the start-up to commercial stage in a variety of disease indications.
Key Points:
- Ken also has experience working with multiple biopharmaceutical companies at the start-up to commercial stage in a variety of disease indications.
- He has an MBA from Thunderbird School of International Management, earned a CFA designation, and has held multiple FINRA licenses.
- Humanigen is pleased to welcome Ken, said Cameron Durrant, CEO of Humanigen.
- I am excited to join Humanigen and utilize my market expertise to help the company continue to advance in the biopharmaceutical field, says Ken Trbovich.
Science,
Biotechnology,
Research,
Pharmaceutical,
Health,
FDA,
Infectious diseases,
Clinical trials,
Branches of biology,
Clinical medicine,
Medicine,
EMR1,
Lymphoma,
Cancer immunotherapy,
Chimeric antigen receptor T cell Humanigen, Inc. (Nasdaq: HGEN), 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 will present at the 2021 LD Micro Invitational XI, held virtually from June 8- 10, 2021.
Key Points:
- Humanigen, Inc. (Nasdaq: HGEN), 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 will present at the 2021 LD Micro Invitational XI, held virtually from June 8- 10, 2021.
- LD Micro is host to some of the most influential conferences in the small-cap world.
- Humanigen has been selected to participate in the first day of the conference, during the Hall of Fame session, which highlights some of the top performers since the LD Micro conference began in 2008.
- 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.
Science,
Biotechnology,
Research,
Pharmaceutical,
Health,
FDA,
Infectious diseases,
Clinical trials,
Clinical research,
Health,
Medical research,
Medical statistics,
Clinical trials,
Chloroarenes,
Placebo,
Sertraline,
Food and Drug Administration,
Clinical endpoint Lenzilumab, should the FDA grant authorization, can address a critical unmet need for an effective treatment.
Key Points:
- Lenzilumab, should the FDA grant authorization, can address a critical unmet need for an effective treatment.
- Lenzilumab achieved the primary endpoint with a 54% relative improvement in the likelihood of SWOV compared to placebo.
- "We are excited and encouraged by these clinical results and are preparing to distribute lenzilumab if granted Emergency Use Authorization," said Edward P. Jordan, MBA, Chief Commercial Officer, Humanigen.
- It is anticipated that thousands of patients will continue to be hospitalized daily, some of whom may benefit from lenzilumab.
Research,
Infectious diseases,
Clinical trials,
Biotechnology,
Other Health,
Health,
Other Science,
Science,
Oncology,
Branches of biology,
Clinical medicine,
Medicine,
Leukemia,
Lymphoma,
Cancer immunotherapy,
Immune system,
EMR1,
Chimeric antigen receptor T cell,
Lenzilumab,
Granulocyte-macrophage colony-stimulating factor The modulation of intrinsic pathways is not due to an off-target effect and provides additional mechanistic rationale for the improved anti-tumor activity observed with GM-CSFKO CAR-T.
Key Points:
- The modulation of intrinsic pathways is not due to an off-target effect and provides additional mechanistic rationale for the improved anti-tumor activity observed with GM-CSFKO CAR-T.
- Humanigens immediate focus is on the development of lenzilumab as a therapy for hospitalized, hypoxic COVID-19 patients.
- 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\xe2\x80\x99s immediate focus is on the development of lenzilumab as a therapy for hospitalized, hypoxic COVID-19 patients.
Key Points:
- Humanigen\xe2\x80\x99s immediate focus is on the development of lenzilumab as a therapy for hospitalized, hypoxic COVID-19 patients.
- 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 .\nAll statements other than statements of historical facts contained in this press release are forward-looking statements.
- Forward-looking statements reflect management\'s current knowledge, assumptions, judgment, and expectations regarding future performance or events.
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.
As is typical with COVID-19 study results, a pre-print of the LIVE-AIR study was published on-line.
Key Points:
- As is typical with COVID-19 study results, a pre-print of the LIVE-AIR study was published on-line.
- The company also completed a public offering in the second quarter of 2021 with net proceeds of $94.1 million.
- The proforma balance of cash and cash equivalents at March 31, 2021 with the proceeds from the public offering is $187.0 million.
- In the second quarter of 2021 the company anticipates the amount of spending on lenzilumab production will be at least the same level as the first quarter of 2021.
Humanigen\xe2\x80\x99s immediate focus is on the development of lenzilumab as a therapy for hospitalized hypoxic COVID-19 patients.
Key Points:
- Humanigen\xe2\x80\x99s immediate focus is on the development of lenzilumab as a therapy for hospitalized hypoxic COVID-19 patients.
- 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.\nAll statements other than statements of historical facts contained in this press release are forward-looking statements.
- Forward-looking statements reflect management\'s current knowledge, assumptions, judgment, and expectations regarding future performance or events.
Retrieved on:
Wednesday, April 21, 2021
Biotechnology,
Pharmaceutical,
Health,
Clinical trials,
Medical specialties,
Health sciences,
Health care,
Sanofi,
Transplantation medicine,
CAC 40,
Pharmaceutical industry,
Lenzilumab,
Graft-versus-host disease Kilcoyne brings to Humanigen strong leadership experience from multinational pharmaceutical and biotechnology companies and a strong clinical background in both Internal Medicine and Public Health Medicine.
Key Points:
- Kilcoyne brings to Humanigen strong leadership experience from multinational pharmaceutical and biotechnology companies and a strong clinical background in both Internal Medicine and Public Health Medicine.
- Prior to this, Dr Kilcoyne held Medical Affairs and Clinical Development leadership roles in Sanofi Pasteur MSD, Roche and Eli Lilly.\nDr.
- Kilcoyne\xe2\x80\x99s responsibilities as Humanigen Chief Medical Officer include the clinical development and regulatory strategy for lenzilumab across its varied potential therapeutic indications including CAR-T, acute GvHD, CMML and COVID-19.
- Additionally, Dr. Kilcoyne will be responsible for the clinical development and regulatory strategy for ifabotuzumab in solid tumors.
