Humanigen Enters into Agreement with PCI Pharma Services as Part of Preparations for Commercialization in the United Kingdom
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,”saidEdward 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.
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.
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.
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.
- 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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Humanigen Investor Relations
PCI Pharma Services Contact
Ty Guzman-Touchberry, WE Communications
email@example.com / +1-212-551-4877
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
Teva Announces Promising Interim Results From Its Study PEARL, About the Impact of AJOVY ® (fremanezumab)24.6.2022 18:54:00 CEST | Press release
Teva Pharmaceuticals Europe B.V. today announces promising interim results from its Pan-European Real World study (PEARL), presented for the first time at the European Academy of Neurology (EAN) Congress in Vienna, Austria. The two-year Pan-European Real World (PEARL) prospective, observational study of AJOVY® (fremanezumab), looks at its effectiveness in patients with chronic migraine or episodic migraine, and is an ongoing study sponsored by Teva Pharmaceuticals Europe BV.1 These findings further offer insight into the treatment of migraine in real-world clinical practice. The interim findings were presented by Faisal Mohammad Amin, Associate Professor of Neurology at the University of Copenhagen, Denmark. Out of the total planned 1100 patients in PEARL, 389 patients are included in the interim analysis presented. These findings show that 54.7% of patients in the study had their monthly-migraine-days reduced by 50% or more, over the six-month period from the start of treatment. Addit
Brigade-M3 European Acquisition Corp. 2021 Annual Report24.6.2022 16:59:00 CEST | Press release
Brigade-M3 European Acquisition Corp. (the “Company”), a special purpose acquisition company that was incorporated on 21 April 2021 under the laws of the Cayman Islands as an exempted company with limited liability and is listed on Euronext Amsterdam, today published its annual report for the period 21 April 2021 to 31 December 2021. The full report can be downloaded from the Company’s website via the following link: https://www.brigadem3eac.com/documents IMPORTANT INFORMATION This press release contains information that qualifies as inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation. DISCLAIMER This announcement is not for distribution or release, directly or indirectly, and should not be distributed in or sent into, the United States, Australia, Canada, Japan, the Cayman Islands or South Africa or any other jurisdiction in which such distribution or release would be unlawful or would require registration or other measures. This announcement does n
PUMA Kicks Off Its Largest Web3 Collaboration To Date, with 10KTF Shop24.6.2022 16:41:00 CEST | Press release
PUMA has entered New Tokyo, the virtual city 10KTF calls home. The shop is known for its streetwear offerings and is owned by Wagmi-san, a digital artisan whose collections and NFT community recently welcomed the global sports brand. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220624005314/en/ PUMA Kicks Off Its Largest Web3 Collaboration To Date, with 10KTF Shop PUMA has entered New Tokyo, the virtual city 10KTF calls home. The shop is known for its streetwear offerings and is owned by Wagmi-san, a digital artisan whose collections and NFT community recently welcomed the global sports brand. (Photo: Business Wire) News of the partnership was shared at an event hosted by 10KTF last night in New York. Their event was one of many hosted during the week of NFT.NYC, a conference attended by crypto industry professionals, traders, and other web3 enthusiasts. The official announcement confirms weeks of speculation after PUMA tw
Suzano outlines ESG milestone achievements and commitments at second annual ESG call24.6.2022 16:14:00 CEST | Press release
Suzano, the world’s largest hardwood pulp producer, today held its second annual ESG Call centered around its ambition to be a ‘regenerative company for a regenerative society’. Today’s ESG Call spotlighted measurable progress and ambitions across three core areas of action: climate change, biodiversity and social development. On Climate Change, the ACT initiative of the French Government and CDP scored Suzano ahead of its pulp and paper industry peers in virtually every metric. In 2021, Suzano brought forward its target for removing 40 million tons of carbon dioxide from the atmosphere from 2030 to 2025 which is being achieved through improvements to its industrial processes, such as systematically replacing the use of fossil fuels at its industrial plants with biomass, and through conversion of degraded land. As part of the company’s social commitments, Suzano launched a target in 2020 to lift 200,000 people out of poverty. This is more than pertinent, given that in Brazil, 10% of th
Kyowa Kirin Receives Positive CHMP Opinion for Use of CRYSVITA ® ▼ (burosumab) for the Treatment of Tumour-Induced Osteomalacia (TIO)24.6.2022 15:38:00 CEST | Press release
Kyowa Kirin Co., Ltd. (TSE: 4151, Kyowa Kirin) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that CRYSVITA® (burosumab) be approved for the treatment of FGF23-related hypophosphataemia in Tumour-Induced Osteomalacia (TIO) associated with phosphaturic mesenchymal tumours (PMTs) that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.1 CRYSVITA is also already licensed for use in the rare disease X-Linked Hypophosphataemia (XLH), for children and adolescents between 1 and 17 years of age with radiographic evidence of bone disease, and in adults.2 Also known as oncogenic osteomalacia, TIO is an acquired disorder caused by typically small, slow-growing, benign PMTs.3,4 It is a rare condition with less than 1000 cases reported in the medical literature,4 which mainly affects adults and with a mean onset age of 40 – 45 years.3,5 TIO is associated with p
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