SHORT HILLS, New Jersey, June 17, 2022-(BUSINESS WIRE)-Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a final -stage clinical biopharmaceutical company dedicated to the prevention and treatment of an overactive immune response called “cytokine shock,” announced today that it has entered into an agreement with PCI Pharma Services (PCI), a global integrated Contract Development Manufacturing Organization (CDMO), to provide import, production and marketing services in the United Kingdom for lenzilumab. Under the agreement, PCI will purchase lenzilumab for resale and distribution in the event that conditional marketing authorization is received in the UK for use in hospitalized patients with COVID-19.
“We are continuing our commercial readiness in the UK and working closely with the Medicines and Healthcare Products Regulatory Agency (MHRA) to meet regulatory requirements for possible approval. conditional marketing. With its global reach, PCI will play a critical role in the supply chain, directly purchasing lenzilumab for continued distribution in the UK and facilitating this important process for Humanigen, ”said Edward Jordan, Chief Commercial Officer. “It is expected that we will complete our response to the MHRA shortly after receiving the first results from the clinical trial of ACTIV-5/BET-B with lenzilumab.”
If approved, lenzilumab will provide an important treatment option for patients hospitalized with COVID-19. Hospitals due to COVID-19 continue in the UK with more than 235,000 people admitted since the beginning of the year and around 5,000 currently in hospital.1 In addition, Humanigen believes that treatment with lenzilumab could provide economic value to the health care system. Previously published research has shown that treatment with lenzilumab can save the National Health Service more than £ 10,000 per patient.2
Lenzilumab is a product of investigation and is not approved or licensed in any country.
Lenzilumab is a patented, class-leading Humaneered® monoclonal antibody that neutralizes GM-CSF, a very important cytokine in the hyper-inflammatory cascade, sometimes referred to as cytokine release syndrome or cytokine shock, associated with COVID-19 and other indications. Lenzilumab binds to and neutralizes GM-CSF, possibly improving outcomes for patients hospitalized due to COVID-19. Humanigen believes that neutralizing GM-CSF with lenzilumab also offers the potential to reduce the hyper-inflammatory cascade known as cytokine release syndrome, which is common in chimeric antigen receptor T-cell therapy (Chimeric antigen receptor T -cell, CAR-T), and acute graft versus host disease (aGvHD).
In CAR-T therapy, lenzilumab successfully reached the predetermined primary endpoint at the recommended dose in a Phase 1b study with Yescarta®, where the overall response rate was 100%, and in which no patient experienced severe cytokine release syndrome or severe neurotoxicity. Based on these results, Humanigen plans to test lenzilumab in a phase 3, randomized, multicenter (“SHIELD”) study, for possible regulatory purposes, to assess its effectiveness and safety when combined with Yescarta and Tecartus® CAR -T therapies to treat non – Hodgkin’s lymphoma. Lenzilumab will also be evaluated to assess the ability to prevent and/or treat aGvHD in patients undergoing allogeneic hematopoietic stem cell transplantation.
A study of lenzilumab was also conducted in patients with acute myelomonocytic leukemia (CMML) with RAS pathway mutations. This study builds on evidence from a Phase 1 study, conducted by Humanigen, that RAS mutations are associated with hyper-proliferative traits, which may be sensitive to GM-CSF neutralization.
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), is a late-stage clinical biopharmaceutical company specializing in the prevention and treatment of an overactive immune response called “cytokine shock”. Lenzilumab is a class-leading antibody that binds and neutralizes Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF). Results from preclinical models indicate that GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in cytokine shock. At the onset of the COVID-19 pandemic, the investigation showed that there was a correlation between high levels of T cells secreting GM-CSF and disease severity, and therefore ICU admissions. The Phase 3 LIVE-AIR study by Humanigen suggests that early intervention with lenzilumab may prevent the consequences of major cytokine shock in patients hospitalized with COVID-19. In addition to developing lenzilumab as a treatment for cytokine shock associated with COVID-19 and CAR-T cell therapies targeting COVID-19, Humanigen is investigating the efficacy of lenzilumab in other inflammatory conditions, e.g. of chronic pain. graft versus host in patients undergoing allogeneic hematopoietic stem cell transplantation, eosinophilic asthma and rheumatoid arthritis. To learn more, please visit www.humanigen.com and follow us on LinkedIn, Twitter and Facebook.
About PCI Pharma Services
PCI is a leading global CDMO, providing its customers with end-to-end integrated drug development, manufacturing and packaging capabilities that increase the market speed of their products and opportunities for commercial success. PCI brings proven experience that includes over 50 successful product launches each year and over five decades in the healthcare services industry. We currently have 30 sites in seven countries (Australia, Canada, USA, Ireland, Wales, Germany and Spain) and over 4,300 employees working to bring life -changing therapies to patients. Innovative technology and ongoing investment enable us to meet worldwide drug development needs throughout the product life cycle, from manufacturing capabilities to commercialization, including the clinical trial supply chain. Our customers regard us as an extension of their business and a collaborative partner with a single goal of improving the lives of patients.
All statements other than statements of historical fact included in this press release are forward-looking statements. They reflect current management knowledge, assumptions, assessments and expectations about future performance or events. Although management believes that the expectations reflected in these statements are based on reasonable assumptions, it does not provide assurance that these expectations will prove correct; therefore readers are advised that actual events or results may differ materially from the contents in the statements expected. Words, such as “will”, “expect”, “aim”, “plan”, “potential”, “possible”, “goals”, “quick”, “continue” and similar expressions refer to statements that rely on, including, but not limited to, statements about the clinical and health economic benefits of lenzilumab in the UK, statements about the adequacy of ACTIV-5/BET-B to support further development in relation to Humanigen’s pursuit of conditional marketing authorization in the UK; statements about the SHIELD, aGvHD and CMML studies, and other statements about the potential of lenzilumab to improve the safety and efficacy of CAR-T and our plans for lenzilumab.
The forward-looking statements are subject to certain risks and uncertainties, including, without limitation, risks inherent in our lack of profitability and our need for additional capital to grow our business; our reliance on partners to further develop our product candidates; the uncertainties inherent in the development, obtaining the necessary regulatory clearances and approvals, and the launch of any new pharmaceutical product; the outcome of pending or future proceedings and arbitrations; and the various risks and uncertainties described under the heading “Risk Factors” in our most recent annual and quarterly reports, and other submissions to the Securities and Exchange Commission.
All future statements are expressly qualified in their entirety by this cautionary statement. Readers are warned not to place undue reliance on such future statements in terms of future forecasts or events. The Company has no obligation to change or update the forward-looking statements contained in this statement, to reflect events or circumstances after the date of this statement, to report new information, to reflect occurrence of unforeseen circumstances, or to update the reasons why actual results may differ from those expected in the expected statements, in each case, unless required by law.
UK Health Security Agency. (June 15, 2022). Healthcare in the UK. GOV.UK Coronavirus (COVID-19) in the UK. Data retrieved June 15, 2022, from https://coronavirus.data.gov.uk/details/healthcare
Kilcoyne, A. et al. (2022). Clinical and economic benefits of lenzilumab and standard of care versus standard of care alone for the treatment of hospitalized patients with coronavirus 19 (COVID-19) disease from the perspective of the National Health Service England. ClinicoEconomics Research and Results. 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 affiliates.
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