HGEN Humanigen Inc.

18.81
+1.07  (+6%)
Previous Close 17.74
Open 17.99
52 Week Low 7.75
52 Week High 29.2
Market Cap $1,103,332,320
Shares 58,656,689
Float 37,365,517
Enterprise Value $972,832,662
Volume 1,298,157
Av. Daily Volume 3,437,449
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Upcoming Catalysts

Drug Stage Catalyst Date
Lenzilumab and Axicabtagene Ciloleucel (ZUMA-19)
Large B-cell Lymphoma
Phase 1/2
Phase 1/2
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Lenzilumab
COVID-19
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Lenzilumab
COVID-19
Phase 3
Phase 3
Phase 3 trial met primary endpoint - March 29, 2021. EUA filing with FDA planned for May 2021. BLA filing due in 2022.
Ifabotuzumab
Glioblastoma multiforme (GBM)
Phase 1
Phase 1
Phase 1 bioimaging trial data released April 9, 2021. Presentation April 10, 2021.
Lenzilumab
Chronic myelomonocytic leukemia (CMML)
Phase 2
Phase 2
Phase 2 trial planned.
Lenzilumab
Prevention/Treatment of Acute GvHD
Phase 2/3
Phase 2/3
Phase 2/3 trial planned.

Latest News

  1. 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™, and Chime Biologics ("Chime"), a world-class contract development and manufacturing organization (CDMO), today announced that they have entered into a manufacturing services agreement to produce lenzilumab bulk drug substance and drug product for Humanigen for commercial sale following receipt of the requisite regulatory authorizations or approvals in regions outside of the United States including Europe, the United Kingdom, India and Brazil.

    "With the recent announcement of the results from the LIVE-AIR Phase 3 clinical trial of…

    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™, and Chime Biologics ("Chime"), a world-class contract development and manufacturing organization (CDMO), today announced that they have entered into a manufacturing services agreement to produce lenzilumab bulk drug substance and drug product for Humanigen for commercial sale following receipt of the requisite regulatory authorizations or approvals in regions outside of the United States including Europe, the United Kingdom, India and Brazil.

    "With the recent announcement of the results from the LIVE-AIR Phase 3 clinical trial of lenzilumab, we are pleased to enter into a partnership with Chime to help with our anticipated commercial production of lenzilumab," said Cameron Durrant, MD, MBA, chief executive officer of Humanigen. "Following a competitive process focused on quality, technical abilities, supply chain and economic criteria we selected Chime as our first foreign CDMO to supply lenzilumab to ex-US markets."

    Under the terms of this agreement, Chime will use the state-of-the-art modular single use KuBio (Cytiva) biologics facility in China. 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.

    "We 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. We are proud of our record for quality, compliance, bioprocessing expertise, and cost effectiveness, and very much look forward to supporting Humanigen in this important program," said Dr. John Zeng, CEO of Chime Biologics.

    About Chime Biologics

    Chime Biologics is a world-class CDMO with operations in China that provides customer-centric and cost-effective outsourcing services for biopharmaceutical development and manufacturing. Its GE KuBio facility is located at Wuhan's BioLake biotech industry development zone. Chime Biologics is ISO 14001:2015 and ISO 45001:2018 certified, and is committed to uphold the highest degree of integrity. Since 2016 Chime Biologics has been providing customers with clinical materials for pre-clinical and clinical stages globally and supporting their production scales from 50L, 200L, 500L to 2,000L across IND-enabling studies to late-stage CMC. Since then, Chime Biologics has been providing clinical supply to over 20 countries worldwide. https://chimebiologics.com/

    About Humanigen, Inc.

    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. Humanigen's immediate focus is on the development of lenzilumab as a therapy for hospitalized, hypoxic COVID-19 patients. Humanigen recently announced plans to initiate a randomized, multicenter, potentially registrational, Phase 2 study to evaluate the efficacy and safety of lenzilumab combined with all commercially available CD19 CAR-T therapies in diffuse large B-cell lymphoma.

    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 is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter and Facebook.

    Forward-Looking Statements

    All 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. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding the volume and timeline for Chime's production of commercial lenzilumab product, as well as statements regarding Humanigen's beliefs relating to the technologies in Humanigen's current pipeline.

    Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in the company's lack of profitability and potential need for additional capital to grow its business; its dependence on partners to further the development of its product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in Humanigen's periodic and other filings with the Securities and Exchange Commission.

    All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. The company undertakes no obligation to revise or update any forward-looking statements made in this presentation to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.

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  2. 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 reported financial results for the first quarter ending March 31, 2021 and provided a regulatory update on lenzilumab.

    "We are encouraged by the achievements Humanigen has made since the beginning of 2021 and by our progress on the emergency use authorization application," stated Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen. "We successfully completed our Phase 3 study of lenzilumab, referred to as LIVE-AIR, for the treatment of newly hospitalized and hypoxic COVID-19 patients. Trial results showed that patients…

    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 reported financial results for the first quarter ending March 31, 2021 and provided a regulatory update on lenzilumab.

    "We are encouraged by the achievements Humanigen has made since the beginning of 2021 and by our progress on the emergency use authorization application," stated Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen. "We successfully completed our Phase 3 study of lenzilumab, referred to as LIVE-AIR, for the treatment of newly hospitalized and hypoxic COVID-19 patients. Trial results showed that patients who received lenzilumab and other treatments, including steroids and/or remdesivir, had a 54% greater relative likelihood of survival without the need for IMV compared with patients receiving placebo and other treatments. We believe this statistically significant result, along with data regarding additional endpoints and further analysis from the study, support the submission of applications for emergency use authorization to the U.S. Food and Drug Administration and conditional marketing authorization in the United Kingdom and the European Union. As is typical with COVID-19 study results, a pre-print of the LIVE-AIR study was published on-line. Positive results from the Phase 1b study of lenzilumab in combination with CAR-T gave further encouragement to our therapeutic approach to breaking the linkage between efficacy and toxicity in CAR-T, and we are designing a Phase 2 study of lenzilumab combined with all commercially available CD19 CAR-T therapies in diffuse large B-cell lymphoma patients."

    Highlights from the First Quarter of 2021 Include:

    Clinical – Lenzilumab in COVID-19

    • The Phase 3 results from the LIVE-AIR study were announced, demonstrating that lenzilumab improves survival without the need for mechanical ventilation in hospitalized, hypoxic patients with COVID-19.
    • Results from the LIVE-AIR Phase 3 study were published in MedRxiv, (https://www.medrxiv.org/content/10.1101/2021.05.01.21256470v1.full.pdf) showing additional analysis from the trial, including patients treated with remdesivir and/or steroids, and a second analysis which showed patients under 85 years of age with C-reactive protein ("CRP"), a widely-utilized inflammatory marker, less than 150 mg/L, derived the greatest benefit of treatment with lenzilumab.
    • With the report of positive top-line results from the LIVE-AIR study in March 2021, the company met the first of two specified milestones under the South Korea license agreement with KPM Tech Co., Ltd. and its affiliate, Telcon RF Pharmaceutical, Inc., and received $6.0 million (or $4.5 million net of withholding taxes and other fees and royalties) in the second quarter of 2021.
    • In preparation for potential launch under emergency use authorization ("EUA") and conditional marketing authorization ("CMA"), Humanigen entered into several supply agreements with contract manufacturing organizations ("CMOs") to supply bulk drug, fill/finish, and commercial packaging.

    Clinical – CAR-T and Oncology

    • The positive data from the Phase 1 study of ifabotuzumab in glioblastoma multiforme was presented at the AACR Annual Meeting 2021.
    • The CAR-T Phase 1b study results in diffuse large B-cell lymphoma("DLBCL") with lenzilumab were announced, showing 100% Objective Response Rate ("ORR") and no severe cytokine release syndrome or severe neurotoxicity at the recommended dose.
    • With the positive Phase 1b results, the company terminated its clinical collaboration agreement with Kite, a Gilead Company, and announced plans to initiate a Phase 2 study with all commercially available CD19 CAR-T therapies for DLBCL patients.

    Corporate

    • Dr. Adrian Kilcoyne was appointed to the newly created role of Chief Medical Officer.
    • Entered into a loan facility with Hercules Capital which will provide the company up to $80 million of secured debt financing.
    • The company launched a public offering of common stock which closed after quarter-end, resulting in net proceeds to Humanigen of $94.1 million.
    • Two patents were issued for the use of lenzilumab, expanding the company's anti-GM-CSF patent portfolio.

    Lenzilumab Regulatory Update

    The company recently held a meeting with FDA to discuss the filing of an EUA for lenzilumab for hospitalized, hypoxic COVID-19 patients, where topline data from the LIVE-AIR study were reviewed, along with the timeline for submission of additional clinical and manufacturing data for lenzilumab. The company plans to submit an EUA application at the end of May 2021. The company has also been in discussion with the Medicines and Healthcare Products Regulatory Agency ("MHRA") for the use of lenzilumab in COVID-19 patients in the United Kingdom and plans to initiate a rolling CMA submission before the end of the second quarter of 2021. The company also plans to submit for CMA to the European Medicines Agency ("EMA") for the use of lenzilumab in the European Union. Further, the company is reviewing the possibility of similar submissions for approval or compassionate use in other territories or countries worldwide.

    The company intends to submit a Biologics License Application ("BLA") to FDA in 2022, for the use of lenzilumab in hospitalized, hypoxic COVID-19 patients. Since BLAs typically require more than one study, the company is currently evaluating the extent to which ACTIV-5/BET-B may serve as a basis for a BLA-confirmatory study for lenzilumab.

    First Quarter Ended March 31, 2021 Financial Results

    Net loss for the three months ended March 31, 2021 was $65.6 million or $1.25 per share as compared to $2.5 million or $0.11 per share for the three months ended March 31, 2020. The increase in net loss for the first quarter 2021 as compared to the first quarter 2020 was largely due to an increase in total expenses, mainly Research and Development expense ("R&D") of $59.2 million from $0.7 million for the three months ended March 31, 2020 to $59.9 million for the three months ended March 31, 2021. The increase in R&D is primarily due to an increase of $51.4 million of expense in lenzilumab manufacturing costs and $7.5 million for clinical trial expenses related to the LIVE-AIR study, both of which began after the first quarter of 2020. The costs incurred for the production of lenzilumab will continue to be included in R&D until lenzilumab is authorized or approved for commercial use, at which point the amounts expended for production will be classified as inventory.

    Cash and Cash Equivalents

    Net cash used in operating activities, net of balance sheet changes, was $35.8 million for the three months ended March 31, 2021. During the three months ended March 31, 2021, the company raised net proceeds of $36.1 million from the sale of shares of common stock under its At-the-Market offering program. The company drew the first tranche of $25.0 million under its credit facility with Hercules Capital, providing net proceeds of $24.4 million. As of March 31, 2021, the company had cash and cash equivalents of $92.9 million. 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. The company expects to continue to use its funds on development and manufacturing of lenzilumab in anticipation of its potential commercialization under EUA or other conditional marketing authorizations. 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. If an EUA or CMA for lenzilumab is not received by mid-2021, the company will seek to decrease or eliminate spending on the production of lenzilumab for commercial use.

    A summary of key financial highlights as of and for the three months ended March 31, 2021 and 2020 is as follows ($ in thousands):

    Three Months Ended March 31,

    2021

     

    2020

     

     
    License revenue $

    486

     

    $

    -

     

     
    Research and development

    59,934

     

    659

     

    General and administrative

    4,948

     

    1,398

     

     
    Loss from operations

    (64,396

    )

    (2,057

    )

     
    Net loss $

    (65,567

    )

    $

    (2,467

    )

     
    Net loss per common share $

    (1.25

    )

    $

    (0.11

    )

     
    Weighted average common shares

    52,655,756

     

    22,854,106

     

    March 31, 2021 December 31, 2020
     
    Cash and cash equivalents $

    92,892

    $

    67,737

     
    Current assets $

    98,758

    $

    68,212

     
    Current liabilities

    53,255

    20,415

     
    Working Capital $

    45,503

    $

    47,797

     

    About Humanigen, Inc.

    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. Humanigen's immediate focus is on the development of lenzilumab as a therapy for hospitalized, hypoxic COVID-19 patients. Humanigen recently announced plans to initiate a randomized, multicenter, potentially registrational, Phase 2 study to evaluate the efficacy and safety of lenzilumab combined with all commercially available CD19 CAR-T therapies in diffuse large B-cell lymphoma.

    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 is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter and Facebook.

    Forward-Looking Statements

    All 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. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding the timing for submission of applications for EUA and BLA, and for conditional marketing authorization in the UK and EU, as well as statements regarding Humanigen's beliefs relating to the technologies in Humanigen's current pipeline.

    Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in the company's lack of profitability and potential need for additional capital to grow its business; its dependence on partners to further the development of its product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in Humanigen's periodic and other filings with the Securities and Exchange Commission.

    All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. The company undertakes no obligation to revise or update any forward-looking statements made in this presentation to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.

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  3. 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 that results from the lenzilumab Phase 3 study in hospitalized COVID-19 patients (referred to as ‘LIVE-AIR') were published online at link.

    About Humanigen, Inc.

    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. Humanigen's immediate focus is on the development of lenzilumab as a therapy for hospitalized hypoxic COVID-19 patients. Humanigen recently announced…

    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 that results from the lenzilumab Phase 3 study in hospitalized COVID-19 patients (referred to as ‘LIVE-AIR') were published online at link.

    About Humanigen, Inc.

    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. Humanigen's immediate focus is on the development of lenzilumab as a therapy for hospitalized hypoxic COVID-19 patients. Humanigen recently announced plans to initiate a randomized, multicenter, potentially registrational, Phase 2 study to evaluate the efficacy and safety of lenzilumab combined with all commercially available CD19 CAR-T therapies in diffuse large B-cell lymphoma.

    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 is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter and Facebook.

    Forward-Looking Statements

    All 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. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding Humanigen's beliefs relating to the technologies in Humanigen's current pipeline.

    Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and potential need for additional capital to grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in Humanigen's periodic and other filings with the Securities and Exchange Commission.

    All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statements made in this presentation to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.

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  4. 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 the appointment of Adrian Kilcoyne, MD, MBA, MPH, to the newly-created role of Chief Medical Officer, effective immediately, reporting to Dr. Cameron Durrant, CEO of Humanigen.

    Dr. 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. His most recent leadership role was in AstraZeneca, where he served as Vice President of Oncology Global Medical Affairs, Head of…

    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 the appointment of Adrian Kilcoyne, MD, MBA, MPH, to the newly-created role of Chief Medical Officer, effective immediately, reporting to Dr. Cameron Durrant, CEO of Humanigen.

    Dr. 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. His most recent leadership role was in AstraZeneca, where he served as Vice President of Oncology Global Medical Affairs, Head of Evidence Generation and External Alliances, and previously as Vice President and Head of US Medical Affairs and Health Economics and Outcomes Research. Dr. Kilcoyne oversaw the development and delivery of the fully integrated global evidence strategy across the company's complete oncology portfolio, including managing development of real-world evidence, epidemiology, biostatistics and data sciences, health economics and outcomes research, payer evidence, medical affairs sponsored research, and investigator research. He also led Global Oncology External Alliances, building strong scientific partnerships to advance patient care.

    "Humanigen is delighted to welcome Dr. Kilcoyne," said Dr. Durrant. "His experience and knowledge in multiple areas, including COVID-19, CAR-T and other oncology clinical development areas, medical affairs, regulatory affairs, evidence generation, health economics, and partnering gives him a unique insight that can be leveraged towards Humanigen's COVID-19, acute GvHD, CAR-T and other oncology programs with lenzilumab and ifabotuzumab. In addition, Adrian's leadership in the external alliances arena will be instrumental in helping guide the progress of Humanigen's pipeline and potential commercialization."

    During his tenure at AstraZeneca, Dr. Kilcoyne oversaw multiple launches of innovative therapies in oncology, including acalabrutinib, a Bruton's tyrosine kinase inhibitor, in the US (marketed as CALQUENCE®) which has also been investigated in two Phase 2 studies in COVID-19 patients. Previously, Dr. Kilcoyne held several leadership positions at Celgene Corporation, a subsidiary of Bristol Myers Squibb, including Executive Medical Director, Global Lymphoma Program Lead, Clinical Research and Development overseeing the development of lenalidomide in Diffuse Large B-Cell Lymphoma (DLBCL). He was also the US lymphoma CAR-T lead supporting the clinical development and launch preparation of lisocabtagene maraleucel (or liso-cel, marketed as Breyanzi®) for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy. Prior to this, Dr Kilcoyne held Medical Affairs and Clinical Development leadership roles in Sanofi Pasteur MSD, Roche and Eli Lilly.

    Dr. Kilcoyne's 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. Dr. Kilcoyne will also be responsible for medical affairs, real-world evidence generation, health economics and outcomes and participate in external alliance evaluation.

    "I am excited to join the Humanigen team at this time and look forward to the opportunity to contribute to the company's strategic long-term growth. I am honored to have the opportunity to deliver on the promise that Humanigen's innovative portfolio offers to patients with significant unmet medical need," said Dr. Kilcoyne.

    Dr. Kilcoyne graduated from Trinity College, Dublin and holds a MSc in Public Health from the London School of Hygiene and Tropical Medicine, along with a MSc in Business Administration from the Warwick Business School. He is the co-author of Pharmaceutical Medicine, a textbook published by Oxford Specialist Handbooks in 2013, edition 2 now being finalized.

    About Humanigen, Inc.

    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. Humanigen's immediate focus is on the development of lenzilumab as a therapy for hospitalized hypoxic COVID-19 patients. Humanigen recently announced plans to initiate a randomized, multicenter, potentially registrational, Phase 2 study to evaluate the efficacy and safety of lenzilumab combined with all commercially available CD19 CAR-T therapies in diffuse large B-cell lymphoma. 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 is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter and Facebook.

    Humanigen Forward-Looking Statements

    This press release contains forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although Humanigen management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding Humanigen's beliefs relating to the technologies in Humanigen's current pipeline.

    These forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in Humanigen's lack of profitability and potential need for additional capital to grow Humanigen's business; Humanigen's dependence on partners to further the development of Humanigen's product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory approvals or authorization for emergency or broader patient use for the product candidate and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in Humanigen's periodic and other filings with the Securities and Exchange Commission.

    All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.

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    • At the recommended Phase 2 dose, lenzilumab in combination with CAR-T, demonstrated a 100% objective response rate (ORR) and no severe cytokine release syndrome or severe neurotoxicity
    • Lenzilumab reduced IL-6, CRP, ferritin, MCP-1, IL-8, and IP-10 (CXCL-10) among others
    • Humanigen now plans to conduct a randomized, potentially registrational, Phase 2 study with lenzilumab combined with all commercially available CD19 CAR-T therapies in DLBCL
    • Humanigen has terminated the ZUMA-19 clinical collaboration agreement with Kite, a Gilead Company

    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…

    • At the recommended Phase 2 dose, lenzilumab in combination with CAR-T, demonstrated a 100% objective response rate (ORR) and no severe cytokine release syndrome or severe neurotoxicity
    • Lenzilumab reduced IL-6, CRP, ferritin, MCP-1, IL-8, and IP-10 (CXCL-10) among others
    • Humanigen now plans to conduct a randomized, potentially registrational, Phase 2 study with lenzilumab combined with all commercially available CD19 CAR-T therapies in DLBCL
    • Humanigen has terminated the ZUMA-19 clinical collaboration agreement with Kite, a Gilead Company

    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 positive data from the Phase 1b portion of ZUMA-19 evaluating the efficacy and safety of lenzilumab in patients treated with CAR-T in diffuse large B-cell lymphoma (DLBCL). At the recommended Phase 2 dose of lenzilumab, the ORR was 100% and no patient experienced severe cytokine release syndrome (CRS) or severe neurotoxicity (NT).

    ZUMA-19 was a clinical study designed to evaluate the efficacy and safety of lenzilumab and CAR-T (axicabtagene ciloleucel, Axi-Cel) in patients with relapsed or refractory DLBCL.

    This study was a standard 3+3 design with three patients administered 600 mg lenzilumab (cohort 1) and three patients administered 1,800 mg lenzilumab (cohort 2) just prior to CAR-T. The recommended Phase 2 dose was determined to be 1,800 mg.

    In the six study patients, the ORR was 83% (n=5) which included four complete responses (CR). In cohort 1, there was no severe CRS (≥ grade 3). One patient experienced grade 3 NT with a two-day duration. At the recommended Phase 2 dose (cohort 2), ORR was 100% (n=3) and the toxicity-free CR (CRS and NT < grade 2) was 66% (n = 2). There was no severe CRS or severe NT at the recommended Phase 2 dose. There were no adverse events attributed to lenzilumab across the study.

    Inflammatory markers were correlated with reduced rates of CRS and NT. Lenzilumab dose-dependently reduced myeloid cytokines IL-6, IL-8, MCP-1, and IP-10 (CXCL-10) and systemic inflammatory markers CRP, ferritin, and SAA.

    "These encouraging results from ZUMA-19 provide further proof of concept that lenzilumab may break the linkage between efficacy and toxicity (CRS and NT) widely-associated with CAR-T, and may improve durability of response," said Dale Chappell, MD, MBA, Chief Scientific Officer, Humanigen. "We believe these data warrant a larger study involving multiple CAR-T therapies."

    Humanigen will initiate a randomized, multicenter, potentially registrational, Phase 2 study to evaluate the efficacy and safety of lenzilumab combined with all commercially available CD19 CAR-T therapies in DLBCL. The study plans to enroll approximately 150 patients and the protocol is being submitted to FDA.

    Humanigen has terminated the clinical collaboration agreement with Kite related to ZUMA-19 and both parties will collaborate to wind down current study activities.

    "Humanigen is pleased to be in a position to proactively develop lenzilumab across the CAR-T landscape and further expand its pipeline," said Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen. "We thank Kite for their sponsorship and contribution that has allowed Humanigen to progress to this exciting point."

    About Humanigen, Inc.

    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. 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's immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and Acute Respiratory Distress Syndrome (ARDS) in cases of SARS-CoV-2 infection and has completed a 520 patient Phase 3 study. 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. Lenzilumab is the first and only anti-human GM-CSF treatment to be tested in the NIH ACTIV-5/BET-B clinical trial. Lenzilumab is being investigated in combination with remdesivir and will be compared with remdesivir alone. Two hundred hospitalized patients 18 years old and greater who need medical care for COVID-19 infection will be enrolled and randomized, half of whom will receive lenzilumab. The evaluation of lenzilumab in this Phase 2 trial began in October 2020 and is expected to be completed in the second half of 2021. Humanigen is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T-cell-engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat Graft versus Host Disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter, and Facebook.

    Humanigen Forward-Looking Statements

    All 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. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding Humanigen's beliefs relating to the technologies in Humanigen's current pipeline.

    Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and potential need for additional capital to grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections of our latest annual and quarterly reports and other filings with the SEC.

    All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.

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