- Phase 1 dose escalation and bioimaging study shows that
ifabotuzumab demonstrates highly specific tumor targeting in
patients with recurrent glioblastoma multiforme
- Results to be presented as a virtual poster at American
Association for Cancer Research (AACR) 2021 Annual Meeting
Humanigen, Inc. (Nasdaq:HGEN), 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 results from the
Phase 1 safety and bioimaging trial of its second Humaneered®
antibody, ifabotuzumab, in patients with glioblastoma multiforme
(GBM). In the study, ifabotuzumab demonstrated highly sensitive,
specific, and reproducible targeting of the tumor and tumor
microenvironment in all patients. The results will be presented as
a poster at the AACR Annual Meeting 2021, held virtually from April
10-15, 2021, and remain available until June 21, 2021.
The Phase 1 study primarily sought to determine the safety and
recommended Phase 2 dose of ifabotuzumab in patients with GBM, the
most frequent and lethal primary brain neoplasm, with 5-year
survival rates of 10%. It is estimated there are more than 18,000
deaths from brain cancer annually in the United States.1
Ifabotuzumab is a non-fucosylated IgG1κ antibody targeting the
EphA3 receptor. EphA3 is a tumor-restricted antigen expressed in
the tumor vasculature and tumor stroma of various solid tumors
including breast, colon, lung, prostate, melanoma, and GBM. The
study showed that, at both doses, ifabotuzumab demonstrated highly
sensitive, specific, and reproducible targeting of the tumor and
tumor microenvironment in all patients. There were no dose-limiting
toxicities observed and all adverse events were readily manageable.
Additional studies are planned to evaluate ifabotuzumab as an
antibody-drug conjugate in solid tumor patients.
“GBM represents an extremely aggressive form of cancer that has
historically eluded effective treatment, and we remain committed to
investigating ifabotuzumab as a potential new approach to treat
this devastating disease as well as other solid tumors,” said Prof.
Andrew Scott, Head, Tumor Targeting Laboratory, Olivia Newton-John
Cancer Research Institute, Professor, School of Cancer Medicine, La
Trobe University, member of the Australian Brain Cancer Mission
Strategic Advisory Group, and Principal Investigator of the Phase 1
study. “The positive results of the Phase 1 study, which show
ifabotuzumab to be well-tolerated and effective at targeting the
EphA3 receptor, support further investigation into ifabotuzumab’s
effect on other solid tumors in a Phase 2 study.”
The poster, titled “A phase 1 safety and bioimaging trial of
ifabotuzumab (KB004) in patients with glioblastoma,” will be
presented virtually at the AACR Annual Meeting during the Phase 1
Clinical Trials Session on Saturday, April 10, 2021. The study was
led by Principal Investigator Andrew Scott from the Olivia
Newton-John Cancer Research Institute in Australia. Funding was
provided by Cure Brain Cancer Foundation, the Queensland
Government, Austin Health, and Humanigen.
“We are pleased to announce the positive Phase 1 results of
ifabotuzumab in patients with gliobastoma multiforme,” said Cameron
Durrant, MD, MBA, Chief Executive Officer of Humanigen. “There is a
tremendous need to advance new therapies for solid tumors, and this
trial shows that ifabotuzumab demonstrates great potential.
Ifabotuzumab represents an important part of Humanigen’s
immuno-oncology arsenal as we advance our pipeline to target a
wide-range of cancers, and we are proud to present our findings at
this year’s AACR Annual Meeting.”
Details for the upcoming event are below:
AACR Annual Meeting 2021
Virtual abstract presentation viewable
starting on Friday, April 9, 2021 Register here:
https://www.aacr.org/meeting/aacr-annual-meeting-2021/registration/
E-poster presentation Date: Saturday, April
10, 2021 Link:
https://www.aacr.org/meeting/aacr-annual-meeting-2021/
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.
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, statements
regarding Humanigen’s ability to attain necessary manufacturing
support from contract development and manufacturing organizations,
the potential for an expanded manufacturing services relationship
with Aji-BioPharma, 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.
1. https://seer.cancer.gov/statfacts/html/brain.html
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version on businesswire.com: https://www.businesswire.com/news/home/20210409005083/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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