Humanigen Announces First Patient Dosed in NIH ACTIV-5/Big Effect Trial Evaluating Lenzilumab™ for COVID-19
29 October 2020 - 10:00PM
Business Wire
- First patient dosed at the
Emory University School of Medicine in Atlanta, Georgia
- Trial will evaluate
lenzilumab with remdesivir, compared to placebo and remdesivir, in
up to 200 patients hospitalized with COVID-19
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 the first patient has been dosed at the Emory University
School of Medicine in Atlanta, Georgia as part of the in the
ACTIV-5 “Big Effect Trial” (ACTIV-5/BET) evaluating lenzilumab with
remdesivir, compared to placebo and remdesivir, in patients
hospitalized with COVID-19. Lenzilumab is the Company’s lead
product candidate and proprietary Humaneered® anti-human
granulocyte macrophage-colony stimulating factor (GM-CSF)
monoclonal antibody designed to optimize antibody properties.
ACTIV-5/BET, which is being conducted by the National Institute
of Allergy and Infectious Diseases (NIAID), part of the U.S.
National Institutes of Health (NIH), is designed to determine
whether certain approved therapies or investigational drugs in
late-stage clinical development show promise against COVID-19 and,
therefore, merit advancement into larger clinical trials.
The adaptive, randomized, double-blind placebo-controlled trial
evaluating lenzilumab with remdesivir will include up to 200
patients across as many as 40 treatment centers in the U.S. There
will be approximately 100 patients assigned to each study arm.
“Nearly 90% of hospitalized COVID-19 patients progress to severe
disease including the cytokine storm for some patients,” said
Vincent C. Marconi, MD, professor of medicine and global health in
Emory University School of Medicine and Emory’s Rollins School of
Public Health. “There is a critical need for a novel COVID-19
therapeutic with potential to reduce patients’ time to recovery,
and this study aims to streamline the pathway to finding these
urgently needed treatments.”
“We are encouraged by lenzilumab’s efficacy and safety data
demonstrated in hospitalized COVID-19 patients to date and believe
we have a game-changing treatment with frontline potential,” said
Cameron Durrant, MD, MBA, chief executive officer of Humanigen. “We
are eager to put lenzilumab through further rigorous testing in
this NIH ACTIV-5 study as we continue to advance our lead candidate
in the next phases of development.”
ACTIV-5/BET is being conducted in collaboration with the NIH’s
public-private partnership Accelerating COVID-19 Therapeutic
Innovations and Vaccines (ACTIV) program. The ACTIV partnership has
evaluated approximately 400 therapeutic agents with a potential
application for COVID-19 and developed a collaborative framework
for prioritizing the most promising candidates, streamlining
clinical trials, coordinating regulatory processes, and leveraging
assets among all partners to rapidly respond to the COVID-19 and
future pandemics. To date, ACTIV has designed five adaptive master
protocols for ACTIV clinical trials, and selected numerous
NIH-supported networks to launch these clinical trials to test
prioritized therapeutic candidates.
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 on ACTIV-5/BET can be found at www.clinicaltrials.gov
using Identifier NCT04583969.
About ACTIV-5/BET
The primary purpose of ACTIV-5/BET, a randomized, double-blind,
placebo-controlled trial, is to evaluate the clinical efficacy of
the different investigational therapeutics relative to the control
arm in hospitalized adults based on the patients’ clinical status
at day 8. The study’s secondary point of evaluation is to evaluate
the clinical efficacy of the different investigational therapeutics
as assessed by the amount of time it takes for each patient to
recover from COVID-19.
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 Cammy Duong Westwicke, an ICR company
Cammy.Duong@Westwicke.com 203-682-8380 Investors Alan Lada
Solebury Trout ALada@SoleburyTrout.com 617-221-8006
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