Humanigen Announces COVID-19 Case Report Demonstrating Rapid Resolution & Discharge after Single IND Emergency Use Authorizat...
October 02 2020 - 8:00AM
Business Wire
- Case report demonstrated
rapid resolution of hypoxemia and mobility and potential benefit of
lenzilumab beyond the initial acute hyper-inflammatory
window
- After 13 weeks of
hospitalization, administration of lenzilumab resulted in rapid
improvement in oxygenation and subsequent discharge
Humanigen, Inc., (Nasdaq: HGEN) (“Humanigen”), a clinical
stage biopharmaceutical company focused on preventing and treating
an immune hyper-response called ‘cytokine storm,’ today announced
that a patient case report on the use of lenzilumab™ in critical
COVID-19 was published online at OSF Preprints. The case report,
titled “COVID-19 associated chronic ARDS successfully treated with
lenzilumab” is available at: https://osf.io/xusr9/.
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The published case describes a 77-year-old Caucasian male
patient with a past medical history of type II diabetes, coronary
artery disease with coronary artery bypass graft, systolic heart
failure, severe chronic obstructive pulmonary disease (COPD) with
emphysema and obstructive sleep apnea. The patient tested positive
for SARS-CoV-2 and was admitted to the ICU in March 2020 for
COVID-19 and put on respiratory isolation. The patient was treated
with steroids, broad spectrum antibiotics for community acquired
pneumonia and bronchodilators for possible COPD exacerbation and
hydroxychloroquine with zinc. The patient continued to deteriorate
for the next 12 weeks with an increase in oxygen demand from
continuous low-flow oxygen to high-flow and eventually intermittent
bilevel positive airway pressure (BIPAP) and developed acute
respiratory distress syndrome (ARDS) during that time.
At week 13 of hospitalization and multiple unsuccessful attempts
at oxygen weaning, an emergency single use IND for lenzilumab,
Humanigen’s Humaneered® anti-human granulocyte macrophage-colony
stimulating factor (GM-CSF) monoclonal antibody drug candidate, was
approved by the FDA and administered to the patient. Seven days
following the administration of lenzilumab, the patient’s oxygen
decreased from high-flow to low-flow nasal cannula and the patient
was able to walk outside of his hospital room with physical
therapy. Sixteen days post-treatment with lenzilumab, the patient
was discharged from the hospital on home oxygen.
A separate case-control study of lenzilumab in severe and
critical COVID-19 published in Mayo Clinic Proceedings demonstrated
an 80% reduction in relative risk of invasive mechanical
ventilation (IMV) and/or death for patients treated with lenzilumab
compared to the matched control group. Lenzilumab is being
evaluated in an ongoing Phase 3 trial and trial site locations can
be found here: https://www.humanigen.com/covid-19-sites.
“The recent case-control study published by the Mayo Clinic
suggests lenzilumab may improve clinical outcomes, oxygenation
requirements, and improve lymphocyte counts in patients with severe
and critical COVID-19 during the acute hyperinflammatory immune
response,” said Juan Pulido, MD, Pulmonologist, Baptist Health
Research Institute. “This patient case report suggests that
lenzilumab may be beneficial to patients who are unable to wean off
of supplemental oxygen and even those who have failed multiple
rounds of prior therapy and are outside the initial acute
hyper-inflammatory window.”
“This patient case underscores our urgency to continue our
development program for lenzilumab in an effort to deliver a
therapeutic that may potentially improve outcomes for hospitalized
COVID-19 patients,” said Cameron Durrant, MD, MBA, chief executive
officer of Humanigen. More details on Humanigen’s programs in
COVID-19 can be found on the company’s website at www.humanigen.com
under the COVID-19 tab, and details of the US Phase 3 potential
registration study can be found at clinicaltrials.gov using
Identifier NCT04351152.
About Humanigen, Inc.
Humanigen, Inc. is developing its portfolio of clinical and
pre-clinical therapies for the treatment of cancers and infectious
diseases via its novel, cutting-edge GM-CSF neutralization and
gene-knockout platforms. We believe that our GM-CSF neutralization
and gene-editing platform technologies have the potential to reduce
the inflammatory cascade associated with coronavirus infection. The
company’s immediate focus is to prevent or minimize the cytokine
release syndrome that precedes severe lung dysfunction and ARDS in
serious cases of SARS-CoV-2 infection. The company is also focused
on creating next-generation combinatory gene-edited CAR-T therapies
using strategies to improve efficacy while employing GM-CSF gene
knockout technologies to control toxicity. In addition, the company
is developing its own portfolio of proprietary first-in-class
EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various
eosinophilic disorders. The company is also exploring the
effectiveness of its GM-CSF neutralization technologies (either
through the use of lenzilumab™ as a neutralizing antibody or
through GM-CSF gene knockout) in combination with other CAR-T,
bispecific or natural killer (NK) T cell engaging immunotherapy
treatments to break the efficacy/toxicity linkage, including to
prevent and/or treat graft-versus-host disease (GvHD) in patients
undergoing allogeneic hematopoietic stem cell transplantation
(HSCT). Additionally, Humanigen and Kite, a Gilead Company, are
evaluating lenzilumab in combination with Yescarta® (axicabtagene
ciloleucel) in patients with relapsed or refractory large B-cell
lymphoma in a clinical collaboration. For more information, visit
www.humanigen.com.
Forward-Looking
Statements
This release contains 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 our expectations for the Phase 3 study and the
potential future development of lenzilumab, our pathway to our
intended submission for, and potential receipt of, an Emergency Use
Authorization and potential subsequent BLA from FDA, and statements
regarding the potential for lenzilumab to be used to prevent or
treat GvHD and, as sequenced therapy with Kite’s Yescarta, in CAR-T
therapies. 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; our dependence on partners
to further the development of our product candidates; the costs and
the uncertainties inherent in the development 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 and elsewhere in the Company's periodic
and other filings with the Securities and Exchange Commission.
All forward-looking statements are expressly qualified in their
entirety by this cautionary notice. You should not place undue
reliance on any forward-looking statements, which speak only as of
the date of this release. 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 or to reflect
new information or the occurrence of unanticipated events, except
as required by law.
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Media Sean Leous Westwicke, an ICR company
sean.leous@westwicke.com 646-866-4012
Investors Victoria Meissner, MD Westwicke, an ICR company
victoria.meissner@westwicke.com 646-677-1837
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