- New Humanigen entity in Australia creates focused
opportunity for partnering, regional clinical trials and market
access
- Structure allows for attractive financial incentives
supported by the Australian government
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 the establishment of
Humanigen Australia Proprietary Limited (“Humanigen Australia Pty
Ltd”), through which Humanigen intends to assess potential
partnering opportunities, facilitate clinical development programs,
and conduct other corporate and business development activities in
the Asia-Pacific region. The first of these was announced on
November 3, with the execution of a licensing agreement for
lenzilumab for South Korea and the Philippines.
The clinical trials that are ongoing, or in advanced planning in
Australia are:
Lenzilumab in cancer patients who are COVID-19 positive and
have pneumonia as part of the C-SMART (COVID-19 Prevention and
Treatment in Cancer; a Sequential Multiple
Assignment Randomized Trial)
The C-SMART study is led by the National Centre for Infections
in Cancer at Peter MacCallum Cancer Centre and will be conducted at
five Australian sites in Melbourne and Sydney. This study will
include over 1,000 cancer patients at risk of, or known positive
for, COVID-19 infection, with a subset of patients in the
lenzilumab arm. The study is supported by a grant from the
Australian Government's Medical Research Future Fund.
Lenzilumab in refractory chronic myelomonocytic leukemia
(CMML) as part of the PREcision Approach to CHronic Myelomonocytic
Leukaemia (PREACH-M) trial
Humanigen is in advanced planning for a Phase 2 study of
lenzilumab in combination with azacitidine in newly-diagnosed CMML
patients who express NRAS/KRAS/CBL mutations, which are known to be
hypersensitive to granulocyte macrophage-colony stimulating factor
(GM-CSF) and therefore may lend themselves to responsiveness to
lenzilumab treatment. CMML is a rare form of hematologic cancer
with no FDA-approved treatment options and a three-year overall
survival rate of 20% and median overall survival of 20 months.1,2
The study is funded by grant from the Australian Government's
Medical Research Future Fund and is expected to commence in
2021.
Ifabotuzumab in glioblastoma multiforme (GBM)
This Phase 1 trial has enrolled 11 of the 12 patients targeted
for full enrollment. Results are expected to be available in the
first half of 2021.
Professor Andrew Scott, Head, Tumour Targeting Laboratory,
Olivia Newton-John Cancer Research Institute, and Professor, School
of Cancer Medicine, La Trobe University, who has been instrumental
in the research and development of both lenzilumab and
ifabotuzumab, said, "The establishment of Humanigen Australia Pty
Ltd speaks to the importance and culmination of 20 years of
research for these two novel antibodies, which we helped discover
and develop in Australia. We hope that lenzilumab will have a major
impact in the treatment of COVID-19 patients. Ifabotuzumab holds
promise as a novel approach to target the tumour microenvironment
in a range of solid tumors."
Bob Atwill, Head of Asia-Pacific Region at Humanigen said,
“Humanigen’s expansion strategy in COVID-19 includes conducting
regional clinical trials, local manufacturing, partnering and
potential early market entry. Some of these opportunities may allow
Humanigen Australia Pty Ltd to benefit from certain financial and
tax incentives offered by the Australian government, including a
potential 43.5% rebate on eligible research and development
expenditures. This is a critical moment for important advancements
in biotechnology and healthcare, and I look forward to progressing
lenzilumab and the rest of the Company’s pipeline in the
Asia-Pacific region as we grow Humanigen Australia Pty Ltd.”
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. We believe that our GM-CSF neutralization
and gene-editing platform technologies have the potential to reduce
the inflammatory cascade associated with coronavirus infection. The
company’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. The company 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, the company
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. The company 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.
Forward-Looking Statements
This release contains 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 our expectations surrounding our operational,
research, development or commercialization activities in the Asia
Pacific region, and our ability to mitigate the impact of COVID-19,
to develop CAR-T or solid cancer therapies or to prevent or treat
GvHD via any of the technologies in our 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 need for additional capital to
conduct the Phase III study and grow our business; our dependence
on partners to further the development of our product candidates;
the uncertainties inherent in the development, attainment of the
requisite regulatory 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 the Company'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. 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 or to reflect
new information or the occurrence of unanticipated events, except
as required by law.
1. Patnaik MM, Tefferi A. Chronic Myelomonocytic leukemia: 2020
update on diagnosis, risk stratification and management. Am J
Hematol. Jan 2020;95(1):97-115. doi:10.1002/ajh.25684
2. Coston T, Pophali P, Vallapureddy R, et al. Suboptimal
response rates to hypomethylating agent therapy in chronic
myelomonocytic leukemia; a single institutional study of 121
patients. Am J Hematol. Jul 2019;94(7):767-779.
doi:10.1002/ajh.25488
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version on businesswire.com: https://www.businesswire.com/news/home/20201123006238/en/
Media Cammy Duong Westwicke, an ICR company
Cammy.duong@westwicke.com 203-682-8380 Investors Alan Lada
Solebury Trout ALada@SoleburyTrout.com 617-221-8006
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