Humanigen’s Partner in South Korea Receives Ministry of Food and Drug Safety (MFDS) Approval to Conduct Phase 1 Study of Lenzilumab
July 22 2021 - 9:59AM
Business Wire
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), today announced
its development and commercialization partners for South Korea and
the Philippines, Telcon RF Pharmaceutical, Inc. (“Telcon”) and KPM
Tech Co., Ltd. (“KPM Tech”), have received approval from South
Korea’s MFDS (the South Korean equivalent of the U.S. FDA) to
conduct a Phase 1 clinical study of lenzilumab, which may support
potential use in the treatment of hospitalized COVID-19
patients.
The study, to be conducted by Telcon and KPM Tech at the Seoul
National University Hospital, is a randomized, placebo-controlled,
double-blind, single-dose, dose escalation of lenzilumab in 20
healthy Korean adults. The primary endpoints of the study are the
safety, tolerability, and pharmacokinetics of lenzilumab. If FDA
grants emergency use authorization for lenzilumab in the treatment
of hospitalized COVID-19 patients in the United States, Telcon and
KPM Tech plan to apply to MFDS for conditional approval for
importation of lenzilumab for use in Korea. Support for conditional
approval would be based on data from this phase 1 study and the
existing data from Humanigen’s Phase 3 LIVE-AIR study. Additional
clinical trials are not expected to be necessary in this
situation.
“We are excited to see our partners Telcon and KPM Tech advance
their efforts to develop lenzilumab for potential use in South
Korea,” said Dr. Cameron Durrant, CEO of Humanigen. “We believe the
data for lenzilumab from our Phase 3 LIVE-AIR study demonstrates
the meaningful improvement in patient care that is possible with
the use of lenzilumab to treat patients hospitalized with COVID-19
pneumonia. We are hopeful that these data, alongside data generated
in Korea by our partners, will allow for the use of lenzilumab in
South Korea.”
Like many countries, South Korea is experiencing rising number
of COVID-19 cases, particularly due to the spread of the Delta
variant. Although 32% of the population has received at least one
vaccine dose, the Delta variant is complicating efforts to control
the spread and contributing to new records for daily infections.1
Treatments for hospitalized COVID-19 patients remains an urgent
medical need to prevent the potential progression of symptoms and
intensive care.
About Humanigen, Inc.
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage
biopharmaceutical company focused on preventing and treating an
immune hyper-response called ‘cytokine storm’. Lenzilumab is a
first-in class antibody that binds to and neutralizes
granulocyte-macrophage colony-stimulating factor (GM-CSF). Results
of preclinical models indicate GM-CSF is an upstream regulator of
many inflammatory cytokines and chemokines involved in the cytokine
storm. Early in the COVID-19 pandemic, investigation showed high
levels of GM-CSF secreting T cells were associated with disease
severity and intensive care unit admission. Humanigen’s Phase 3
LIVE-AIR study suggests early intervention with lenzilumab may
prevent consequences of a full-blown cytokine storm in hospitalized
patients with COVID-19. Humanigen is developing lenzilumab as a
treatment for cytokine storm associated with CD19-targeted CAR-T
cell therapies and exploring the effectiveness of lenzilumab in
other inflammatory conditions such as acute Graft versus Host
Disease (GvHD) in patients undergoing allogeneic hematopoietic stem
cell transplantation (HSCT), eosinophilic asthma, and rheumatoid
arthritis. Humanigen is also developing a portfolio of clinical and
pre-clinical therapies for the treatment of inflammation and
immuno-oncology. For more information, visit www.humanigen.com and
follow Humanigen on LinkedIn, Twitter, and Facebook.
About KPM Tech Co., Ltd/Telcon RF Pharmaceutical,
Inc.
KPM Tech was established in March 1971 to develop and
manufacture plating chemicals, fully automatic plating equipment
products, and associated technologies. On January 7, 2003, KPM Tech
was approved for registration and transaction on the KOSDAQ stock
market of the Korea Exchange. Key areas of focus include the
manufacture and sale of PCBs, electronic communication
semiconductors, surface treatment chemicals for automobile parts,
and fully automatic plating equipment. KPM Tech with its largest
shareholder, Telcon RF Pharma, have also invested on new drug
development companies such as Emmaus Life Sciences, Vivozon and
Abion.
Telcon was established in January 1999 to produce connectors,
cable assemblies, etc. used in the manufacture of wireless
communication equipment and today also manufactures and
commercializes pharmaceutical products. The company was listed on
the KOSDAQ market on November 24, 2014 and major business sectors
include Telcon RF and pharmaceuticals/biotechnology. The
pharmaceutical/biotechnology business division operates a Korea
Good Manufacturing Practice (KGMP) production facility to produce
liquid formulation products and other formulations such as tablets,
pills, and capsules. There is also a continued investment in the
development of new drugs.
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 the ability of KPM Tech and Telcon
to attain required regulatory approvals in the covered territories;
the possibility of receipt of emergency use authorization from FDA
for lenzilumab in hospitalized COVID-19 patients; and our other
plans to explore the effectiveness of lenzilumab and other
candidates in our development portfolio as therapies for other
inflammation and immune-oncology indications.
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 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 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 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 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.
- Cha, S. (2021, July 20). South Korea reports record daily
infections as Delta variant drives surge. Reuters.
https://www.reuters.com/world/asia-pacific/south-korea-reports-new-daily-record-1784-covid-19-cases-kdca-2021-07-21/
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210722005678/en/
Humanigen Media Grace Catlett RXMD Gcatlett@rxmedyn.com
516-318-8563 Humanigen Investor Relations Ken Trbovich
Humanigen trbo@humanigen.com 650-410-3206
Humanigen (NASDAQ:HGEN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Humanigen (NASDAQ:HGEN)
Historical Stock Chart
From Sep 2023 to Sep 2024