Humanigen Submits Application to FDA for Emergency Use Authorization for Lenzilumab in COVID-19
May 28 2021 - 9:00AM
Business Wire
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 that the company submitted
an application to the US Food and Drug Administration (FDA)
requesting Emergency Use Authorization (EUA) for lenzilumab for the
treatment of patients hospitalized with COVID-19. This EUA
application follows positive results from the LIVE-AIR Phase 3
clinical trial evaluating the ability of lenzilumab to improve the
likelihood of survival without ventilation (SWOV) in newly
hospitalized COVID-19 patients.
“Filing for EUA in the U.S. is a critical step to making a
therapeutic option available for COVID-19,” said Cameron Durrant,
MD, MBA, Chief Executive Officer, Humanigen. “There is a need for
therapies for hospitalized patients who require supplementary
oxygen. Treatments can be lifesaving; despite vaccinations,
infections and significant breakthrough disease will continue.
Lenzilumab, should the FDA grant authorization, can address a
critical unmet need for an effective treatment. We are extremely
grateful to the investigative team and volunteers in the clinical
trial program, as their involvement was vital in delivering this
positive Phase 3 study.”
Lenzilumab achieved the primary endpoint with a 54% relative
improvement in the likelihood of SWOV compared to placebo.
Lenzilumab also improved the relative likelihood of SWOV by 92% in
subjects who received both corticosteroids and remdesivir and
resulted in a 3-fold improvement in the likelihood of SWOV in
patients with a CRP<150 mg/L and less than 85 years of age. In
these patients, a 2.2-fold improvement in the likelihood of
survival was observed with lenzilumab. No serious adverse events
were attributed to lenzilumab and the overall safety profile was
comparable to placebo.
"We are excited and encouraged by these clinical results and are
preparing to distribute lenzilumab if granted Emergency Use
Authorization," said Edward P. Jordan, MBA, Chief Commercial
Officer, Humanigen. "We are committed to getting lenzilumab into
the hands of medical professionals for the treatment of COVID-19.
It is anticipated that thousands of patients will continue to be
hospitalized daily, some of whom may benefit from lenzilumab.”
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’s immediate focus is on the
development of lenzilumab as a therapy for hospitalized, hypoxic
COVID-19 patients. Humanigen recently announced plans to initiate a
randomized, multicenter, potentially registrational, Phase 2 study
to evaluate the efficacy and safety of lenzilumab combined with all
commercially available CD19 CAR-T therapies in diffuse large B-cell
lymphoma.
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). For more
information, visit www.humanigen.com and follow Humanigen on
LinkedIn, Twitter and Facebook.
Forward-Looking Statements
All statements other than statements of historical facts
contained in this press release are 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 benefits for
patients if emergency use authorization for lenzilumab were
granted, and other statements regarding Humanigen’s beliefs
relating to the technologies in Humanigen’s current pipeline.
Forward-looking statements are subject to a number of risks and
uncertainties including, but not limited to, the risks inherent in
the company’s lack of profitability and potential need for
additional capital to grow its business; its dependence on partners
to further the development of its product candidates; the
uncertainties inherent in the development, attainment of the
requisite regulatory authorizations and 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 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 rely upon any
forward-looking statements as predictions of future events. The
company undertakes no obligation to revise or update any
forward-looking statements made in this presentation to reflect
events or circumstances after the date hereof, to reflect new
information or the occurrence of unanticipated events, to update
the reasons why actual results could differ materially from those
anticipated in the forward-looking statements, in each case, except
as required by law.
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Humanigen Media Grace Catlett RXMD Gcatlett@rxmedyn.com
516-318-8563
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