- Interim data suggest clinically meaningful impact on patient
recovery from COVID-19 with an estimated 37 percent more recoveries
observed in lenzilumab arm of Phase 3 trial versus current standard
of care
- Data safety monitoring board recommendation demonstrates the
Phase 3 trial is in the “promising zone” of the adaptive trial
design
- CRADA between Humanigen and U.S. government provides for
regulatory and other support to submit an EUA and BLA
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
investigational treatment lenzilumab, today announced positive
interim Phase 3 data of lenzilumab in patients hospitalized with
COVID-19. This interim analysis for sizing and powering suggests
that lenzilumab had a clinically meaningful impact on patient
recovery, with an estimated 37 percent more recoveries observed in
the lenzilumab arm of the randomized, placebo-controlled,
double-blinded study versus current standard of care (SOC).
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Lenzilumab
“These interim data demonstrate the potential of lenzilumab as a
frontline treatment option for patients hospitalized with
COVID-19,” said Cameron Durrant, MD, MBA, chief executive officer
of Humanigen. “We are encouraged by these data and the clinically
meaningful impact that lenzilumab may have for patients with
COVID-19 over and above remdesivir and/or steroids.”
The data safety monitoring board (DSMB) composed of independent
subject matter experts conducted an interim analysis of the
unblinded data for trial sizing and powering and recommended
increasing the target number of events (recoveries) from 257 to 402
to maintain the power of the study at 90 percent. The adaptive
trial design only allows for the addition of patients if interim
data are in the “promising zone” (i.e., achieving or surpassing an
average improvement in recoveries of 29 percent (hazard ratio (HR)
> 1.29) through day 28).
The company remains blinded to the data and based on the
recommended number of events, the HR was calculated to be 1.37, an
average of 37 percent more recoveries observed in the lenzilumab
arm compared to the control arm. Any observed benefit in the
lenzilumab arm would be over and above the use of remdesivir and/or
steroids which are among the treatments that have been used as SOC
in both the lenzilumab treatment arm and the placebo arm of the
study.
At the recommendation of the DSMB, the company plans to increase
enrollment to achieve 402 events (approximately 515 patients). This
increase in enrollment ensures an even higher probability of
success in meeting the primary endpoint and maintains the power of
the study at 90 percent. The next interim analysis for efficacy is
planned when the study reaches 75 percent events (302 events) which
will require approximately 390 patients to be enrolled in the
trial.
“Based on this feedback from the DSMB, we believe the Phase 3
trial is significantly de-risked. Targeting 402 events improves the
probability of success, maintains the power of the study at 90
percent, and further supports our plans for Emergency Use
Authorization (EUA) and Biologics License Application (BLA)
submission,” said Dale Chappell, MD, MBA, chief scientific officer
of Humanigen. “We are working to quickly activate additional trial
sites across the U.S. to support rapid enrollment and increase
access to lenzilumab with a continued commitment to inclusion and
diversity.”
A Cooperative Research and Development Agreement (CRADA) that
Humanigen entered into with the Joint Program Executive Office for
Chemical, Biological Radiological and Nuclear Defense (JPEO-CBRND),
provides for, among other support, regulatory, statistical and
manufacturing subject matter advice to anticipation of an
application for an EUA and eventually a BLA submission. The
activities under the CRADA are being funded by the Biomedical
Advanced Research and Development Authority (BARDA), part of the
Office of the Assistant Secretary for Preparedness and Response
(ASPR) at the U.S. Department of Health and Human Services (HHS),
working in collaboration with JPEO-CBRND. These activities include
providing regulatory representatives who may participate in
informal or formal meetings with the U.S. Food and Drug
Administration (FDA) and providing comments on submission prior to
submitting to FDA.
Humanigen intends to file for EUA in the first quarter of 2021
either following interim data at 75 percent or at study completion.
The Phase 3 trial evaluating patients hospitalized with COVID-19 is
enrolling at sites across the U.S. and Latin America. Current
enrollment stands at 300 patients.
Interim Phase 3 lenzilumab in COVID-19 data analysis
highlights:
- 78 percent of trial participants on either remdesivir or
dexamethasone (or other steroids) or both (across both arms of the
study)
- 65 percent of trial participants with oxygen saturation 94
percent or on low-flow oxygen support
- 35 percent of trial participants on high-flow oxygen or
non-invasive positive pressure ventilation at time of
enrollment
- 45 percent of trial participants were 65 years of age or
older
- 50 percent of trial participants from diverse populations
- No serious adverse events have been attributed to
lenzilumab
- These findings apply across both arms of the study
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.
Details on the U.S. Phase 3 lenzilumab clinical trial can be found
at clinicaltrials.gov using Identifier NCT04351152 or by visiting
www.StopStorm.com.
.
Humanigen to Host Investor Conference Call
The Company will host an investor call and webcast today,
Friday, November 6, 2020 at 9:00 a.m. EST to discuss these results
and the recently announced CRADA issued through a collaboration
between the Department of Defense and the U.S. Department of Health
and Human Services to meet the U.S. government’s Operation Warp
Speed goals.
To participate in the conference call, please dial toll free
1-800-410-4983 or toll/International number 1-303-223-4366. The
conference ID number is 21972012. A simultaneous webcast of the
call and presentation can be accessed by visiting:
http://public.viavid.com/index.php?id=142380.
In addition, a replay of the webcast will be available on the
company website for 30 days following the event.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201106005112/en/
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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