- In a weekly cohort of 4,754 newly hospitalized patients,
addition of lenzilumab to standard of care (SOC) could result in
over £5.5 million in cost savings weekly1
- Lenzilumab plus SOC resulted in per‑patient cost savings
between £8,462 and £17,277 (net savings of £1,162 - £9,977)
depending on patient population1
- The number of COVID-19 cases continues to remain high with
approximately 20,000 patients currently hospitalized in the UK,2
demonstrating the urgent need for both clinically effective and
cost-effective variant-agnostic treatments for hospitalized
patients
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.
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
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.
About Humanigen
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.
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 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.
References
- 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
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version on businesswire.com: https://www.businesswire.com/news/home/20220419005500/en/
Humanigen Investor Relations Ken Trbovich Humanigen
trbo@humanigen.com 650-410-3206
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