National Institutes of Health Launches its ACTIV-5 “Big Effect Trial” Evaluating Humanigen’s Lenzilumab™ as Potential...
October 13 2020 - 11:00AM
Business Wire
- Lenzilumab among the
promising agents selected for ACTIV program from pool of
approximately 400 candidate agents
Humanigen, Inc., (Nasdaq: HGEN) (“Humanigen”), a clinical
stage biopharmaceutical company focused on preventing and treating
an immune hyper-response called ‘cytokine storm’ with its lead drug
candidate lenzilumab™, today announced that the National Institute
of Allergy and Infectious Diseases (NIAID), part of the U.S.
National Institutes of Health (NIH), launched its ACTIV-5 “Big
Effect Trial” (ACTIV-5/BET), 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. ACTIV-5/BET, which will
enroll at as many as 40 US sites, will evaluate lenzilumab with
remdesivir, compared to placebo and remdesivir, in hospitalized
COVID-19 patients with approximately 100 patients assigned to each
study arm. Humanigen is providing lenzilumab for the study, which
is fully funded by NIH.
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.
“Lenzilumab is one of the few Phase 3 treatment options in
development for COVID-19, and we believe that its mechanism of
action as an immunomodulator could work very nicely with remdesivir
and potentially enhance first line standard of care therapy to
prevent serious and potentially fatal outcomes,” said Cameron
Durrant, MD, MBA, chief executive officer of Humanigen. “We are
excited at NIH’s recognition of the potential of our drug candidate
for this new ACTIV trial, reinforcing the importance of testing and
funding for therapeutics to treat COVID-19, and we are eager to put
lenzilumab through further rigorous testing to contribute to the
battle against this pandemic.”
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
ACTIV is public-private partnership that has evaluated hundreds
of available therapeutic agents with potential application for
COVID-19, prioritized the most promising candidates, designed and
harmonized five adaptive master protocols for ACTIV clinical
trials, and selected numerous NIH-supported networks to launch
these clinical trials to test prioritized therapeutic candidates.
Master protocols allow coordinated and efficient evaluation of
multiple investigational agents as they become available, but
within the same clinical trial structure, across multiple study
sites. Adaptive protocols swiftly weed out experimental drugs that
do not demonstrate effectiveness and identify those that do.
Adaptive master protocols reduce administrative burden and cost,
provide a flexible framework to rapidly identify drugs that work,
and rapidly move additional experimental agents into the trial. In
addition to lenzilumab from Humanigen, compounds currently included
in the ACTIV protocols include remdesivir from Gilead, LY-CoV555
from Eli Lilly and Company, Apixaban from Bristol Myers Squibb Co.
and Eli Lilly and Company, and Risankizumab from Boehringer
Ingelheim/AbbVie Inc.
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 as sequenced therapy 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 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
associated with CMC work 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 Alan Lada Solebury Trout
ALada@SoleburyTrout.com 617-221-8006
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