Humanigen Announces Cooperative Research & Development Agreement with the Department of Defense to Develop Lenzilumab for COV...
November 06 2020 - 7:00AM
Business Wire
- The Cooperative Research and
Development Agreement (CRADA) with the Department of Defense (DoD)
in support of Operation Warp Speed (OWS) aims to improve the
availability of lenzilumab for patients with COVID-19
- Humanigen’s development
efforts complemented by full-scale, integrated team of OWS leading
experts and U.S. Government decision makers dedicated to advancing
lenzilumab ahead of a potential Emergency Use Authorization (EUA)
submission
Humanigen, Inc., (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 company and the
Department of Defense (DoD) Joint Program Executive Office for
Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND
or JPEO) have entered into a Cooperative Research and Development
Agreement (CRADA) in collaboration with 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), in support of
Operation Warp Speed (OWS) to assist in the development of
lenzilumab in advance of a potential Emergency Use Authorization
(EUA) for COVID-19.
The CRADA complements Humanigen’s development efforts, providing
access to a full-scale, integrated team of OWS manufacturing and
regulatory subject matter experts, leading decision makers and
statistical support in anticipation of applying for EUA and
subsequently a Biologics License Application for lenzilumab as a
potential treatment for COVID-19. The CRADA also provides that OWS
regulatory experts will work hand in hand with the Company on U.S.
Food and Drug Administration (FDA) communications, meetings and
regulatory filings. The CRADA aims to support the ongoing
lenzilumab Phase 3 clinical trials, focusing on efficiently
generating EUA and BLA submissions. In addition to providing access
under EUA, a goal of the CRADA is to ensure lenzilumab receives the
benefits provided by Public Law 115-92.
Humanigen's investigational treatment lenzilumab, a proprietary
Humaneered® anti-human granulocyte macrophage-colony stimulating
factor (GM-CSF) monoclonal antibody, is designed to prevent and
treat an immune hyper-response called ‘cytokine storm’, a
complication considered to be a leading cause of COVID-19 death.
Data show that up to 89 percent of patients hospitalized with
COVID-19 are at risk of this immune hyper-response, which is
believed to trigger the acute respiratory distress syndrome in
severe cases of COVID-19.
Cameron Durrant, MD, MBA, chief executive officer of Humanigen
said, “We are honored to be part of Operation Warp Speed, receive
this CRADA, and collaborate with JPEO to advance lenzilumab as a
potential response treatment and seek a potential EUA. We have been
working tirelessly to advance lenzilumab for COVID-19 and are
excited to have the integrated expert team at OWS prioritize
lenzilumab research and development during this critical time.”
Lenzilumab was also selected by the National Institutes of
Health (NIH) to be evaluated among the promising COVID-19 agents
for its ACTIV-5 “Big Effect Trial” (ACTIV-5/BET) which will enroll
patients at up to 40 sites in the U.S.
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. Details on
ACTIV-5/BET can be found at clinicaltrials.gov using Identifier
NCT04583969.
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 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 the potential future development of lenzilumab
to minimize or reduce the immune hyper-response called cytokine
storm, which is believed to trigger the acute respiratory distress
syndrome in severe cases of COVID-19, the potential benefits of the
CRADA with JPEO and other assistance from the federal government to
the Company’s efforts to seek an Emergency Use Authorization and
ultimately a BLA from, be approved by, FDA for such use or to help
CAR-T reach its full potential or to deliver benefit in preventing
GvHD. 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 and need for additional capital to
grow our business; our dependence on partners to further the
development of our product candidates; the uncertainties inherent
in the development, attainment of requisite regulatory approvals
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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version on businesswire.com: https://www.businesswire.com/news/home/20201106005073/en/
Media Cammy Duong Westwicke, an ICR company
cammy.duong@westwicke.com 203-682-8380
Investors Alan Lada Solebury Trout alada@troutgroup.com
856-313-8206
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