Humanigen Announces Lenzilumab in COVID-19 Program Updates
October 02 2020 - 7:00AM
Business Wire
- Type B meeting with FDA provided feedback on Emergency Use
Authorization submission plans
- Phase 3 trial expanded to Brazil with seven sites actively
enrolling; patients already dosed
- 17 active trial sites in the US, including California, Texas
and Florida
- Approval from Mexican regulatory agency to expand study in
country with fourth highest reported deaths worldwide
- Top-line data planned for the fourth quarter of 2020
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 updates on its lenzilumab in
COVID-19 development program, including written guidance received
from the US Food and Drug Administration (FDA) following a Type B
meeting to obtain feedback on plans for an Emergency Use
Authorization (EUA). FDA agreed that the Company’s intended
submission may be sufficient to support an EUA request, subject to
Phase 3 trial data, and provided guidance and support for the
Company’s Biologics License Application and approval pathway. The
Company also announced several updates on its Phase 3 registration
study with lenzilumab which is continuing to enroll in the U.S. and
Brazil, and now has been approved to expand to Mexico. The
randomized, placebo-controlled, double-blinded Phase 3 trial
currently has a total of 29 approved sites with 24 actively
enrolling hospitalized adult COVID-19 patients who require
supplemental oxygen and are at high risk of disease
progression.
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“FDA was very helpful and provided clear guidance on our EUA
submission plan,” said Cameron Durrant, MD, MBA, chief executive
officer of Humanigen. “We are encouraged by our Type B meeting and
remain confident in our program and preparedness plans in advance
of a potential EUA.”
“Lenzilumab is one of the few Phase 3 treatment options in
development for COVID-19 and has the potential to be a first line
treatment to improve time to recovery and prevent serious and
potentially fatal outcomes in patients who are hospitalized with
COVID-19. The addition of new trial sites in Brazil and Mexico
expands access to this study, which is especially critical for
regions experiencing a surge in cases, including centers which are
already enrolling in the US in areas referred to as ‘hot-spots’,”
said Dale Chappell, MD, MBA, chief scientific officer of Humanigen.
“Trial enrollment continues as we work towards top-line data
announcement in the fourth quarter. In parallel, we are furthering
our large-scale commercial manufacturing production efforts, having
recently announced agreements with Thermo Fisher and Lonza, in
addition to Catalent, which are planned to ensure access to
lenzilumab if granted EUA.”
Key lenzilumab COVID-19 development program updates
include:
Updates from FDA Type B meeting:
- The Company’s intended submission may be sufficient to support
an EUA request, subject to Phase 3 trial data
- The FDA provided feedback on the Company’s Chemistry,
Manufacturing and Controls (CMC) plan, EUA labelling and the
Statistical Analysis Plan (SAP) and agreed that no material changes
are needed across these elements.
US Phase 3 clinical trial program updates:
- 17 trial sites are active in the US
- The study is continuing to enroll at sites including Los
Angeles, Dallas, Orlando, Jacksonville, Charlotte, Atlanta and
Minneapolis, cities associated with high rates of confirmed
COVID-19 cases.1
Brazil Phase 3 clinical trial program updates:
- Seven of the 12 approved trial sites in Brazil are currently
validated to begin enrolling patients.
- Several patients have been dosed across multiple sites in
Brazil in four of the seven centers now enrolling patients.
- Program clinical trial investigators in Brazil stressed the
importance of this program and urgency for enrollment during a
recent investigator meeting.
- Brazil has more than 4.8 million reported cases of COVID-19 and
has reported over 143,000 deaths, second in the world only to the
US.2
Mexico Phase 3 clinical trial program updates:
- The Mexican regulatory agency, COFEPRIS, has granted permission
to commence a Phase 3 study of lenzilumab in patients with COVID-19
in Mexico, expanding the strategic global reach of this
program.
- Clinical trial sites are being activated to initiate patient
enrollment in the study, which will follow the same protocol that
was approved by the FDA and is running in the sites in US and
Brazil; the data from all sites to be aggregated for Phase 3
purposes.
- Mexico has the fourth highest number of reported COVID-19
related deaths in the world and has reported more than 743,000
cases of COVID-19 in total.3
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 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, 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
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.
1 Johns Hopkins University & Medicine Coronavirus Resource
Center. COVID-19 United States Cases by County. Updated October 1,
2020. Accessed October 1, 2020. https://coronavirus.jhu.edu/us-map
2 The New York Times. Brazil Covid Map and Case Count. Updated
October 1, 2020. Accessed October 1, 2020.
https://www.nytimes.com/interactive/2020/world/americas/brazil-coronavirus-cases.html
3 The New York Times. Covid World Map: Tracking the Global
Outbreak. Updated October 1, 2020. Accessed October 1, 2020.
https://www.nytimes.com/interactive/2020/world/americas/mexico-coronavirus-cases.html
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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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