Humanigen Announces Thermo Fisher Partnership to Expand Manufacturing for COVID-19 Therapeutic Candidate Lenzilumab
September 23 2020 - 7:00AM
Business Wire
- Collaboration further strengthens manufacturing capabilities
and capacity in advance of potential Emergency Use Authorization in
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 a strategic collaboration
with Thermo Fisher Scientific, a world leader in serving science,
to expand the manufacturing capacity for lenzilumab, currently in a
Phase 3 registration study in patients with COVID-19, to support a
potential Emergency Use Authorization (EUA).
This multi-year manufacturing partnership adds to Humanigen’s
large scale commercial production efforts, including recently
announced partnerships with Lonza and Catalent, in advance of a
potential 2020 EUA and subsequent commercialization of lenzilumab,
the company’s proprietary Humaneered® anti-human granulocyte
macrophage-colony stimulating factor (GM-CSF) monoclonal antibody.
Thermo Fisher will begin the technical transfer of the lenzilumab
bulk drug substance process and commercial scale production could
begin before the end of this year.
“Manufacturing preparation, precision and expertise are critical
as we execute on an aggressive strategy, pending a potential EUA
from the FDA, to deliver a COVID-19 therapeutic this winter that
has the potential to reduce the risk of ventilation or death and
send patients home from the hospital earlier,” said Cameron
Durrant, MD, MBA, Chief Executive Officer of Humanigen. “Thermo
Fisher provides biologics manufacturing expertise and scalable
capacity to further support our production and growth
trajectory."
“Effective therapeutics are an important part of the overall
approach to curb the arc of the current pandemic and we are
committed to enabling leading therapeutic innovations forward for
patients through comprehensive supply chain capabilities and
expertise,” said Leon Wyszkowski, president, commercial operations
for Thermo Fisher’s pharma services business.
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 ClinicalTrials.gov 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 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 to minimize or reduce
the severity of lung dysfunction associated with severe and
critical COVID-19 infections or to receive an Emergency Use
Authorization 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
conduct the Phase 3 study and grow our business; our dependence on
partners to further the development of our product candidates; 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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version on businesswire.com: https://www.businesswire.com/news/home/20200923005188/en/
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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