NJ-HUMANIGEN
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a late-stage clinical biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ today announced it entered into an agreement with PCI Pharma Services (PCI), a leading integrated global contract development manufacturing organization (CDMO), to provide importation, release and commercialization services in the United Kingdom (UK) for lenzilumab. Under the agreement, PCI will purchase lenzilumab for resale and distribution in the event a Conditional Marketing Authorization is received in the UK for use in patients hospitalized with COVID-19.
“We continue our commercial preparation in the UK and in parallel are working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to address regulatory requirements for a potential Conditional Marketing Authorization. With its global reach, PCI will provide a critical function in the supply chain, by directly purchasing lenzilumab for further distribution in the UK and facilitating this key process for Humanigen,” said Edward Jordan, Chief Commercial Officer. “It is anticipated that we will complete our response to MHRA soon after the top-line results from the ACTIV-5/BET-B clinical trial with lenzilumab are received.”
If authorized, lenzilumab will offer an important treatment option to patients hospitalized with COVID-19. Hospitalizations from COVID-19 continue in the United Kingdom with more than 235,000 admitted year-to-date and with ~5,000 currently hospitalized.1 In addition, Humanigen believes that treatment with lenzilumab may deliver economic value to the healthcare system. Previously published research has demonstrated that treatment with lenzilumab may save the National Health Service over £10,000 per patient.2
Lenzilumab is an investigational product and is not approved or authorized in any country.
About Lenzilumab
Lenzilumab is a proprietary Humaneered® first-in-class monoclonal antibody that has been proven to neutralize GM-CSF, a cytokine of critical importance in the hyperinflammatory cascade, sometimes referred to as cytokine release syndrome, or cytokine storm, associated with COVID-19 and other indications. Lenzilumab binds to and neutralizes GM-CSF, potentially improving outcomes for patients hospitalized with COVID-19. Humanigen believes that GM-CSF neutralization with lenzilumab also has the potential to reduce the hyperinflammatory cascade known as cytokine release syndrome common to chimeric antigen receptor T-cell (CAR-T) therapy and acute Graft versus Host Disease (aGvHD).
In CAR-T, lenzilumab successfully achieved the pre-specified primary endpoint at the recommended dose in a Phase 1b study with Yescarta® in which the overall response rate was 100% and no patient experienced severe cytokine release syndrome or severe neurotoxicity. Based on these results, Humanigen plans to test lenzilumab in a randomized, multicenter, potentially registrational, Phase 3 study (“SHIELD”) to evaluate its efficacy and safety when combined with Yescarta and Tecartus® CAR-T therapies in non-Hodgkin lymphoma. Lenzilumab will also be tested to assess its ability to prevent and/or treat aGvHD in patients undergoing allogeneic hematopoietic stem cell transplantation.
A study of lenzilumab is also underway for patients with chronic myelomonocytic leukemia (CMML) exhibiting RAS pathway mutations. This study builds on evidence from a Phase 1 study, conducted by Humanigen, that showed RAS mutations are associated with hyper-proliferative features, which may be sensitive to GM-CSF neutralization.
About Humanigen
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), is a late-stage clinical biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’. Lenzilumab is a first-in class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Results from preclinical models indicate GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in the cytokine storm. Early in the COVID-19 pandemic, investigation showed high levels of GM-CSF secreting T cells were associated with disease severity and intensive care unit admission. Humanigen’s Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent consequences of a full-blown cytokine storm in hospitalized patients with COVID-19. Humanigen is developing lenzilumab as a treatment for cytokine storm associated with COVID-19 and CD19-targeted CAR-T cell therapies and is also exploring the effectiveness of lenzilumab in other inflammatory conditions such as acute Graft versus Host Disease in patients undergoing allogeneic hematopoietic stem cell transplantation, eosinophilic asthma, and rheumatoid arthritis. For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter, and Facebook.
About PCI Pharma Services
PCI is a leading global CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 50 successful product launches each year and over five decades in the healthcare services business. We currently have 30 sites across seven countries (Australia, Canada, U.S., Ireland, Wales, Germany, and Spain) and over 4,300 employees that work to bring life-changing therapies to patients. Leading technology and continued investment enable us to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and into commercialization. Our clients view us as an extension of their business and a collaborative partner with the shared goal of improving patients’ lives.
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 potential clinical and UK healthcare economic benefits of lenzilumab, statements pertaining to the sufficiency of results from ACTIV-5/BET-B to support further progress in respect of Humanigen’s pursuit of Conditional Marketing Authorization in the UK; statements regarding the SHIELD, aGvHD, and CMML studies, and other statements regarding the potential for lenzilumab to improve the safety and efficacy of CAR-T and our plans relating to lenzilumab.
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 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 or arbitration involving the company; 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, or 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.
References
- UK Health Security Agency. (2022, June 15). Healthcare in United Kingdom . GOV.UK Coronavirus (COVID-19) in the UK. Retrieved June 15, 2022, from https://coronavirus.data.gov.uk/details/healthcare
- Kilcoyne, A. et al. (2022). Clinical and economic benefits of lenzilumab plus standard of care compared with standard of care alone for the treatment of hospitalized patients with coronavirus disease 19 (COVID-19) from the perspective of National Health Service England. ClinicoEconomics and Outcomes Research . https://doi.org/10.2147/CEOR.S360741
Humaneered® is a trademark of Humanigen, Inc.
Yescarta® and Tecartus® are trademarks of Gilead Sciences, Inc., or its related companies.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220616005133/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Azafaros to Present at BIO International Convention 2025 Following Successful €132M Series B Financing9.6.2025 07:00:00 CEST | Press release
Azafaros, a clinical-stage biotechnology company developing novel therapies for rare lysosomal storage disorders (LSDs), today announced that it will present at the 2025 BIO International Convention taking place in Boston, USA, from 16-19 June. The company’s presentation is scheduled for Monday, June 16 at 16:45 ET in Room 153B. The presentation will highlight Azafaros’ progress in developing nizubaglustat, its lead investigational compound for the treatment of rare lysosomal storage disorders with neurological involvement, including GM1 and GM2 gangliosidoses and Niemann-Pick disease type C (NPC). This announcement follows Azafaros’ recently completed and oversubscribed €132 million Series B financing round, which will support advancing nizubaglustat into pivotal clinical development. The company is on track to initiate two Phase 3 trials in GM1/GM2 gangliosidoses and NPC in 2025. Earlier this year, Azafaros reported positive topline results from its ongoing Phase 2 study evaluating n
A-CAP Announces Successful Divestiture of Standard de Liège SA and Immobilière du Standard de Liège SRL6.6.2025 22:32:00 CEST | Press release
Successful Transaction Marks Another Milestone in A-CAP’s Soccer Club Portfolio Strategy Advantage Capital Holdings, LLC (“A-CAP” or “The Company”), a New York-based insurance and financial services company with over $12 billion in assets, today announced the successful divestiture of Standard de Liège SA (“Standard Liège” or the “Club”), one of Belgium's most historic soccer clubs, and Immobilière du Standard de Liège SRL, the corporate entity that owns the Club's stadium, Maurice Dufrasne Stadium, to a consortium of buyers led by Standard Liège Chief Executive Officer Giacomo Angelini. This transaction marks the end of 777 Partners’ legacy involvement with the Club and sets the stage for the Club’s future growth and success, both on and off the field. Benefits of the transaction include: Increased stability across the Club’s shareholder base, which clears the path for future investments, Operational clarity, establishing a unified direction that will allow both players and management
Populous Acquires Fentress Architects, Expanding Global Aviation Portfolio6.6.2025 20:00:00 CEST | Press release
Populous, the world-renowned design firm specializing in sport and entertainment venues, today announced the acquisition of Denver-based Fentress Architects, a global leader in iconic aviation projects and prominent public buildings, including convention centers, museums and government facilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250606849000/en/ Los Angeles International Airport. Designed by Fentress Architects. This strategic acquisition unites two of the most respected names in architecture, combining Populous’ unparalleled expertise in designing memorable experiences with Fentress’ award-winning portfolio of aviation, civic and cultural landmarks. The acquisition significantly broadens the scope and scale of services that Populous can offer clients across the globe. Bruce Miller, Populous Global Chair and CEO, commented: “We are committed to expanding the breadth of our practice. Fentress Architects has lon
Vertex Presents New Data on Benefits of ALYFTREK® and Importance of Achieving Lower Sweat Chloride Levels at the European Cystic Fibrosis Conference6.6.2025 18:00:00 CEST | Press release
- Oral presentation on outcomes following treatment with CFTR modulators show that improvements in CFTR function, as measured by lower sweat chloride, correlate with better outcomes for people with cystic fibrosis - - Oral presentation on new post hoc data from randomized, controlled and open-label trials suggest improved quality of life results with ALYFTREK compared to TRIKAFTA® – Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data across multiple studies demonstrating positive clinical and quality of life benefits of treatment with CFTR modulators and, in particular, ALYFTREK® (vanzacaftor/tezacaftor/deutivacaftor), which is approved in the United States and United Kingdom and is currently under review with health authorities in the EU, Canada, Australia, New Zealand and Switzerland. These data were presented at this year’s European Cystic Fibrosis Society’s (ECFS) 48th European Cystic Fibrosis Conference held June 4-7, 2025, in Milan, Italy. During the conferenc
Andersen Consulting tilføjer dimension med David and Golyat6.6.2025 16:33:00 CEST | Pressemeddelelse
Andersen Consulting udbygger sin globale konsulentkapacitet gennem en samarbejdsaftale med David and Golyat, en filippinsk konsulentvirksomhed inden for digital strategi. Med et stærkt fokus på business intelligence, kundeindsigt og digital first-eksekvering arbejder David and Golyat med kunder på tværs af flere sektorer – herunder regeringer, udviklingsorganisationer og private virksomheder – for at skabe langsigtet værdi gennem datainformerede beslutninger. Miko David, administrerende partner i David and Golyat, siger: "Vi ser frem til samarbejdet med Andersen Consulting, da det er en milepæl i vores vækstforløb. Ved at kombinere vores ekspertise inden for digital strategi og Andersen Consultings globale platform er vi i stand til at levere endnu større værdi til kunder, der navigerer på komplekse markeder." "Dette samarbejde betyder, at vi kan tilføre en ekstra dimension til vores globale konsulentplatform," siger Mark L. Vorsatz, global bestyrelsesformand og administrerende direktø
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom