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.
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.
Contacts:
FOR AVID BIOSERVICESStephanie Diaz
(Investors) Vida
Strategic
Partners
415-675-7401 sdiaz@vidasp.com
Tim Brons
(Media) Vida
Strategic
Partners415-675-7402 tbrons@vidasp.com
FOR HUMANIGEN Alan Lada (Investors)Solebury
Trout856-313-8206alada@troutgroup.com
Cammy Duong (Media)Westwicke, an ICR
company203-682-8380Cammy.Duong@Westwicke.com
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