Emergent BioSolutions Inc. (NYSE:EBS) (Emergent) and Humanigen,
Inc. (NASDAQ:HGEN) (Humanigen) today announced that they have
entered into a contract development and manufacturing (CDMO)
services agreement to accelerate the drug product manufacturing of
lenzilumab™, an anti-human granulocyte macrophage-colony
stimulating factor (GM-CSF) monoclonal antibody designed to prevent
and treat an immune hyper-response called “cytokine storm.”
Emergent will provide access to manufacturing capacity reserved for
and provided by the U.S. government under Humanigen’s Cooperative
Research and Development Agreement (CRADA) with the Department of
Defense’s (DoD) Joint Program Executive Office for Chemical,
Biological, Radiological and Nuclear Defense (JPEO-CBRND) 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. Lenzilumab is currently in a Phase 3
clinical trial evaluating patients hospitalized with COVID-19.
Humanigen intends to file for emergency use authorization (EUA) in
the first quarter of 2021.
Under the terms of the agreement, Emergent will provide its
integrated CDMO services for the manufacturing of drug product
batches to support Humanigen’s efforts to increase supply of
lenzilumab in anticipation of a potential EUA beginning in the
first quarter of 2021, including utilization of a new
state-of-the-art flex fill line at Emergent’s Baltimore, MD
(Camden) drug product manufacturing facility. This newly expanded
facility was built to provide increased capacity and flexibility to
support companies in need of clinical and commercial manufacturing
capabilities. The parties intend to negotiate a commercial
manufacturing services agreement that could include future fill
batches for a biologics license application (BLA).
“As we continue to advance lenzilumab for patients hospitalized
with COVID-19, we are executing on plans to ensure that we have the
necessary support for the next phase of our growth. Partnering with
leading CDMOs like Emergent BioSolutions to help us build out our
manufacturing capacity is a cornerstone to that strategy,” said
Cameron Durrant, MD, MBA, chief executive officer of Humanigen.
“The impact of BARDA’s support through our CRADA and its
public-private CDMO partnership with Emergent is vital to our
progress and bringing innovative solutions for patients with
COVID-19.”
For Emergent, this agreement follows and is in addition to the
landmark public-private CDMO partnership between Emergent and
BARDA, announced in June 2020, to pave the way for high-priority
innovators leveraging reserved capacity at their Drug Substance and
Drug Product facilities.
“Drug product manufacturing is a hallmark capability of our CDMO
services, and we stand ready to harness our expertise to advance
lenzilumab, Humanigen’s COVID-19 therapeutic candidate,” said Syed
T. Husain, senior vice president and CDMO business unit head at
Emergent BioSolutions. “Every second counts in the fight against
COVID-19, and we are proud that Humanigen trusts us to rapidly
deploy our clinical-to-commercial manufacturing operations to
fulfill the urgent need for COVID-19 therapeutic options.”
This agreement marks Emergent’s seventh CDMO collaboration with
government and industry partners working to deliver COVID-19
vaccine and therapeutic solutions.
About Emergent BioSolutions
Emergent BioSolutions is a global life sciences company whose
mission is to protect and enhance life. Through Emergent’s
specialty products and contract development and manufacturing
services, Emergent is dedicated to providing solutions that address
public health threats. Through social responsibility, Emergent aims
to build healthier and safer communities. Emergent aspires to
deliver peace of mind to its patients and customers so they can
focus on what’s most important in their lives. In working together,
Emergent envisions protecting or enhancing 1 billion lives by 2030.
For additional information, visit Emergent’s website and follow
Emergent on LinkedIn, Twitter and Instagram.
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. Humanigen believes that its GM-CSF
neutralization and gene-editing platform technologies have the
potential to reduce the inflammatory cascade associated with
coronavirus infection. Humanigen’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.
Humanigen 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, Humanigen 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. Humanigen 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 and
follow Humanigen on LinkedIn, Twitter and Facebook.
Emergent BioSolutions Safe Harbor Statement
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Any statements, other than statements of historical fact,
including statements regarding Emergent’s ability to advance
potential solutions to combat coronavirus disease as well as the
anticipated production of the lenzilumab™ Phase 3 COVID-19
experimental therapeutic candidate at expected levels in the
expected timeframe, as well as the potential negotiation of a
future commercial manufacturing services agreement that could
include fill batches for a BLA, are forward-looking statements.
These forward-looking statements are based on current intentions,
beliefs and expectations regarding future events. Emergent cannot
guarantee that any forward-looking statement will be accurate.
Investors should realize that if underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual
results could differ materially from expectations. Investors are,
therefore, cautioned not to place undue reliance on any
forward-looking statement. Any forward-looking statement speaks
only as of the date of this press release, and, except as required
by law, Emergent does not undertake to update any forward-looking
statement to reflect new information, events or circumstances.
There are a number of important factors that could cause
Emergent’s actual results to differ materially from those indicated
by such forward-looking statements, including the success of the
planned development program; the timing of and ability to obtain
and maintain regulatory approvals or authorization for emergency or
broader patient use for the product candidate; and Emergent’s
commercialization, marketing and manufacturing capabilities. The
foregoing sets forth many, but not all, of the factors that could
cause actual results to differ from expectations in any
forward-looking statement. Investors should consider this
cautionary statement, as well as the risk factors identified in
Emergent’s periodic reports filed with the SEC, when evaluating
Emergent’s forward-looking statements.
Humanigen Forward-Looking Statements
This press release contains forward-looking statements.
Forward-looking statements reflect management's current knowledge,
assumptions, judgment and expectations regarding future performance
or events. Although Humanigen 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 use of lenzilumab to treat
patients hospitalized with COVID-19, Humanigen’s expectations
regarding the timeline to file for and obtain EUA, as well as a
potential BLA filing, statements regarding Humanigen’s ability to
attain necessary manufacturing support from CDMOs, the potential
for an expanded manufacturing services relationship with Emergent,
and statements regarding Humanigen’s beliefs relating to any of the
other technologies in Humanigen’s current pipeline. These
forward-looking statements are subject to a number of risks and
uncertainties including, but not limited to, the risks inherent in
Humanigen’s lack of profitability and need for additional capital
to grow Humanigen’s business; Humanigen’s dependence on partners to
further the development of Humanigen’s product candidates; the
uncertainties inherent in the development, attainment of the
requisite regulatory approvals or authorization for emergency or
broader patient use for the product candidate 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 Humanigen'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. Humanigen undertakes 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/20210125005359/en/
Emergent BioSolutions Contacts:
Investors: Robert G. Burrows Vice President, Investor
Relations 240-631-3280 BurrowsR@ebsi.com
Media: Miko B. Neri Senior Director, Global
Communications & Public Affairs 240-631-3392 nerim@ebsi.com
Humanigen Contacts:
Investors: Alan Lada Solebury Trout 856-313-8206
alada@troutgroup.com
Media: Cammy Duong Westwicke, an ICR company 203-682-8380
Cammy.Duong@Westwicke.com
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