Humanigen Announces Peer-Reviewed Publication Demonstrating the Potential Clinical and Economic Benefits of Lenzilumab from the Perspective of the NHS
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ today announced a peer-reviewed publication in ClinicoEconomics and Outcomes Research outlining the potential clinical and health economic benefits of lenzilumab, if authorized or approved for use in the United Kingdom.
“As COVID-19 continues to place significant burden on the National Health Service (“NHS”), this paper demonstrates there is an opportunity to realize significant cost savings for healthcare systems of the UK while improving outcomes for patients. As a variant-agnostic treatment, lenzilumab may offer both a clinically effective and cost-effective option against current and emerging variants,” said Adrian Kilcoyne, M.D., Chief Medical Officer, Humanigen, the lead author of the publication.
The publication demonstrated, in all cases, lenzilumab plus SOC improved all specified clinical outcomes compared with SOC alone. Additionally, patient selection, utilizing CRP<150 mg/L as a biomarker, optimized both clinical and economic outcomes. The observed cost savings are mainly driven by fewer bed days, days on invasive mechanical ventilation and ICU days.
The greatest per-patient cost savings were for patients aged <85 years, CRP <150 mg/L, and receiving remdesivir of £10,427 (net savings of £3,127 after expected lenzilumab acquisition costs); and for Black patients with CRP <150 mg/L of £17,277 (net savings of £9,977).
“During these unprecedented and challenging times, we are preparing to commercialize lenzilumab, if authorized or approved, as a single day treatment and a potential driver of clinical and economic value to patients and the healthcare system,” said Edward Jordan, Chief Commercial Officer, Humanigen.
This peer-reviewed publication highlights the significant costs of treating hospitalized COVID-19 patients and the economic benefits of potentially improving survival without ventilation, reducing ventilator use, hospital days and ICU days which may be associated with adding lenzilumab to standard of care.
Lenzilumab is an investigational product and is not approved or authorized in any country.
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 hyper-inflammatory 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.
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), is a clinical-stage 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.
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 health economic benefits of lenzilumab, if authorized or approved for use in the United Kingdom as a therapy for COVID-19, statements regarding the SHIELD and LIVE-AIR studies, and other statements regarding improving the safety and efficacy of CAR-T and our plans relating to lenzilumab and ifabotuzumab.
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; 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.
- 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
- UK Health Security Agency. (2022). GOV.UK Coronavirus (COVID-19) in the UK. Retrieved April 12, 2022, from https://coronavirus.data.gov.uk/details/healthcare
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Humanigen Investor Relations
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Maxion Wheels and Challenge4 Set New Guinness World Record for High-Altitude Drive in an All-electric Vehicle23.5.2022 19:37:00 EEST | Press release
Maxion Wheels, the world’s largest wheel manufacturer, and long-distance driver Rainer Zietlow and the Challenge4 team, successfully set a new Guinness World Record for driving to the highest altitude in the all-electric VW ID.4 GTX. Equipped with Maxion’s robust, lightweight and sustainable steel wheels, the team drove to the top of Bolivia’s Uturuncu volcano, 5,816 meters above sea level, breaking the previous record set in 2020 by approx. 45 meters of altitude. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220523005816/en/ New highest altitude by an electric vehicle Guinness World Record is set by Maxion Wheels and Challenge4 with the ascent of a VW ID.4 GTX riding on Maxion steel wheels to the top of Bolivia's Uturuncu volcano. (Photo: Business Wire) Guinness World Records today presented Challenge4 with the official certificate during a press conference at the German Embassy in La Paz, Bolivia. “This world record under
Innovative IoT Modem Card From Thales Makes It Easier to Build a 5G World of Trust23.5.2022 18:15:00 EEST | Press release
Thales announces the new Cinterion® MV32 modem card that makes it quicker and easier for manufacturers to build and maintain resilient, high-performance 5G devices that will transform everyday life in the years ahead. Harnessing the full potential of 5G Mobile Broadband connectivity, the new modem card is designed to be at the heart of a wide array of demanding IoT (Internet of Things) use cases, such as securely connecting enterprises, remote patient care and intelligent monitoring of renewable energy generation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220522005024/en/ Thales 5G IoT (Graphic: Thales) Effortlessly connecting 5G networks and next-gen IoT devices The 5G roll-out will not only bring unprecedented mobile broadband speed to billions of people worldwide. It also offers an extraordinary leap in the sheer number of devices that cellular networks can support. Connectivity will be enabled for billions more mach
Fabasoft Approve is now an autonomous limited liability company23.5.2022 17:05:00 EEST | Press release
Fabasoft Approve, the product for managing technical data and documents launched by software manufacturer Fabasoft and employed successfully in industry since 2019, became an independent company on April 27, 2022. Entrepreneur Andreas Dangl will assume the management of the new digitalization services company. As a defining leader in the Fabasoft Group, Dangl was responsible for the development of Fabasoft Cloud technology and was both the idea generator as well as the principal architect of software products including Fabasoft Approve. He is now pooling his expertise in the corporation based in Linz (Austria) with the express intention of re-imagining the digital world in mechanical and plant engineering and rendering it simpler to navigate. “Fabasoft Approve GmbH provides the perfect framework for meeting the needs of our industrial customers in an even more focused way. We have exciting times ahead of us, in which my team and I, together with our clients, will tap the innovative pot
“PUMA and the Land of Games”: New Virtual Place on Roblox for PUMA Fans to Connect and Compete23.5.2022 17:00:00 EEST | Press release
PUMA in partnership with Wonder Works studio launches a vibrant and immersive sports-based experience on Roblox, a global online platform connecting millions of people through shared experiences. PUMA and the Land of Games experience features Roblox newest Layered Clothing technology, where players can customize their characters with hyperrealistic clothing that fits any avatar body type to wear PUMA from head to toe. As they explore the experience, fans will unlock new zones and additional PUMA sportswear pieces. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220523005611/en/ PUMA in partnership with Wonder Works studio launches a vibrant and immersive sports-based experience on Roblox, a global online platform connecting millions of people through shared experiences. (Photo: Business Wire) “PUMA and the Land of Games” offers the global Roblox community to bring out their inner athlete through sports mini games and training
Fabrice Tocco, Dawex co-CEO, Speaking at the World Economic Forum Annual Meeting in Davos about Data Ecosystems to Respond to Competitiveness and Economic Sovereignty Challenges23.5.2022 16:40:00 EEST | Press release
Dawex, the leading technology company for data exchange, data marketplace and data hub, announced today that co-CEO Fabrice Tocco will be speaking at the World Economic Forum Annual Meeting in Davos, and will share his vision on creating new data exchange ecosystems to respond to environmental and economic challenges. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220523005654/en/ Live Session at Davos (Photo: Dawex) “Strengthening Trust in Public-Private Data Exchanges” Tuesday, May 24 at 13:30 CET Data ecosystems have become a fundamental component of business competitiveness and economic sovereignty. In today’s economy where data has become a product of unlimited potential, with its own value, and a source of new revenue streams, Dawex technology allows organizations to create new ecosystems around data exchange platforms that meet regulatory requirements and address traceability and security challenges. About Dawex In to
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