Humanigen Reports Positive Data With Lenzilumab in the ZUMA-19 CAR-T Phase 1b Study in DLBCL & Plans to Initiate a Potential ...
April 19 2021 - 7:00AM
Business Wire
- At the recommended Phase 2 dose, lenzilumab in combination with
CAR-T, demonstrated a 100% objective response rate (ORR) and no
severe cytokine release syndrome or severe neurotoxicity
- Lenzilumab reduced IL-6, CRP, ferritin, MCP-1, IL-8, and IP-10
(CXCL-10) among others
- Humanigen now plans to conduct a randomized, potentially
registrational, Phase 2 study with lenzilumab combined with all
commercially available CD19 CAR-T therapies in DLBCL
- Humanigen has terminated the ZUMA-19 clinical collaboration
agreement with Kite, a Gilead Company
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 positive data from the
Phase 1b portion of ZUMA-19 evaluating the efficacy and safety of
lenzilumab in patients treated with CAR-T in diffuse large B-cell
lymphoma (DLBCL). At the recommended Phase 2 dose of lenzilumab,
the ORR was 100% and no patient experienced severe cytokine release
syndrome (CRS) or severe neurotoxicity (NT).
ZUMA-19 was a clinical study designed to evaluate the efficacy
and safety of lenzilumab and CAR-T (axicabtagene ciloleucel,
Axi-Cel) in patients with relapsed or refractory DLBCL.
This study was a standard 3+3 design with three patients
administered 600 mg lenzilumab (cohort 1) and three patients
administered 1,800 mg lenzilumab (cohort 2) just prior to CAR-T.
The recommended Phase 2 dose was determined to be 1,800 mg.
In the six study patients, the ORR was 83% (n=5) which included
four complete responses (CR). In cohort 1, there was no severe CRS
(≥ grade 3). One patient experienced grade 3 NT with a two-day
duration. At the recommended Phase 2 dose (cohort 2), ORR was 100%
(n=3) and the toxicity-free CR (CRS and NT < grade 2) was 66% (n
= 2). There was no severe CRS or severe NT at the recommended Phase
2 dose. There were no adverse events attributed to lenzilumab
across the study.
Inflammatory markers were correlated with reduced rates of CRS
and NT. Lenzilumab dose-dependently reduced myeloid cytokines IL-6,
IL-8, MCP-1, and IP-10 (CXCL-10) and systemic inflammatory markers
CRP, ferritin, and SAA.
“These encouraging results from ZUMA-19 provide further proof of
concept that lenzilumab may break the linkage between efficacy and
toxicity (CRS and NT) widely-associated with CAR-T, and may improve
durability of response,” said Dale Chappell, MD, MBA, Chief
Scientific Officer, Humanigen. “We believe these data warrant a
larger study involving multiple CAR-T therapies.”
Humanigen will 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 DLBCL. The study plans to enroll approximately 150
patients and the protocol is being submitted to FDA.
Humanigen has terminated the clinical collaboration agreement
with Kite related to ZUMA-19 and both parties will collaborate to
wind down current study activities.
“Humanigen is pleased to be in a position to proactively develop
lenzilumab across the CAR-T landscape and further expand its
pipeline,” said Cameron Durrant, MD, MBA, Chief Executive Officer,
Humanigen. “We thank Kite for their sponsorship and contribution
that has allowed Humanigen to progress to this exciting point.”
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 Acute Respiratory Distress Syndrome (ARDS) in cases
of SARS-CoV-2 infection and has completed a 520 patient Phase 3
study. 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.
Lenzilumab is the first and only anti-human GM-CSF treatment to be
tested in the NIH ACTIV-5/BET-B clinical trial. Lenzilumab is being
investigated in combination with remdesivir and will be compared
with remdesivir alone. Two hundred hospitalized patients 18 years
old and greater who need medical care for COVID-19 infection will
be enrolled and randomized, half of whom will receive lenzilumab.
The evaluation of lenzilumab in this Phase 2 trial began in October
2020 and is expected to be completed in the second half of 2021.
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.
Humanigen 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 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
our lack of profitability and potential need for additional capital
to 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 of our
latest annual and quarterly reports and other filings with the
SEC.
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. 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, 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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version on businesswire.com: https://www.businesswire.com/news/home/20210419005250/en/
Humanigen Media Grace Catlett RXMD Gcatlett@rxmedyn.com
516-318-8563
Humanigen Investors Alan Lada Solebury Trout
ALada@SoleburyTrout.com 617-221-8006
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