Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP) (“Avid”) and
Humanigen, Inc. (NASDAQ:HGEN) (“Humanigen”) today announced that
they have entered into a manufacturing services agreement to expand
production capacity for lenzilumab™, Humanigen’s therapeutic
candidate in development for COVID-19. Lenzilumab is an anti-human
granulocyte macrophage-colony stimulating factor (GM-CSF)
monoclonal antibody designed to prevent and treat an immune
hyper-response called “cytokine storm” associated with COVID-19.
Humanigen has completed enrollment of its 520 patient Phase 3
clinical trial of lenzilumab in hospitalized COVID-19 patients.
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Under the terms of this Current Good Manufacturing Practice
(cGMP) agreement, Avid will initiate technical transfer and
analytical validation activities for lenzilumab with the goal of
delivering cGMP drug substance batches to support Humanigen’s
regulatory and potential commercial activities. This collaboration
enhances commercial production efforts for lenzilumab in advance of
potential filings for emergency use authorization (EUA) and
subsequent Biologics License Application (BLA) later this year.
“Having recently completed enrollment in our Phase 3 clinical
trial of lenzilumab, we are also focusing on scalable manufacturing
capacity to help ensure access in advance of a potential EUA
filing,” said Cameron Durrant, MD, MBA, chief executive officer of
Humanigen.
“As the COVID-19 pandemic continues to rage in the U.S. and
around the world, it is essential that life science companies like
Avid and Humanigen align our areas of expertise to speed the
development and commercialization of valuable therapeutics that can
make a difference in the lives of patients. At Avid, we are proud
to play our part in these important efforts,” said Timothy Compton,
chief commercial officer of Avid. “Lenzilumab is an exciting
COVID-19 therapeutic candidate and the type of complex biologic for
which Avid possesses decades of manufacturing success. We are
pleased to be trusted by Humanigen to provide the critical CDMO
services that will be essential for achieving the company’s
regulatory and commercialization goals for lenzilumab.”
About Avid Bioservices, Inc.
Avid Bioservices is a dedicated contract development and
manufacturing organization (CDMO) focused on development and cGMP
manufacturing of biopharmaceutical drug substances derived from
mammalian cell culture. The company provides a comprehensive range
of process development, cGMP clinical and commercial manufacturing
services for the biotechnology and biopharmaceutical industries.
With 28 years of experience producing monoclonal antibodies and
recombinant proteins, Avid's services include cGMP clinical and
commercial drug substance manufacturing, bulk packaging, release
and stability testing and regulatory submissions support. For
early-stage programs the company provides a variety of process
development activities, including upstream and downstream
development and optimization, analytical methods development,
testing and characterization. The scope of our services ranges from
standalone process development projects to full development and
manufacturing programs through commercialization.
www.avidbio.com
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.
Avid Bioservices Forward-Looking Statements
Statements in this press release which are not purely
historical, including statements regarding Avid Bioservices, Inc.'s
intentions, hopes, beliefs, expectations, representations,
projections, plans or predictions of the future, are
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements involve risks and uncertainties including, but not
limited to, the risk that Humanigen does not receive EUA and/or BLA
approval and the risk that the company, as part of a larger
manufacturing network, may not be a significant source of
commercial supply following a BLA approval, if any. Our business
could be affected by a number of other factors, including the risk
factors listed from time to time in our reports filed with the
Securities and Exchange Commission including, but not limited to,
our annual report on Form 10-K for the fiscal year ended April 30,
2020 and subsequent quarterly reports on Form 10-Q, as well as any
updates to these risk factors filed from time to time in our other
filings with the Securities and Exchange Commission. We caution
investors not to place undue reliance on the forward-looking
statements contained in this press release, and we disclaim any
obligation, and do not undertake, to update or revise any
forward-looking statements in this press release except as may be
required by law.
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 EUA, as well as a potential BLA
filing, statements regarding Humanigen’s ability to scale the
manufacturing of lenzilumab, 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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FOR AVID BIOSERVICES
Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401
sdiaz@vidasp.com
Tim Brons (Media) Vida Strategic Partners 415-675-7402
tbrons@vidasp.com
FOR HUMANIGEN Alan Lada
(Investors) Solebury Trout 856-313-8206 alada@troutgroup.com
Cammy Duong (Media) Westwicke, an ICR company 203-682-8380
Cammy.Duong@Westwicke.com
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