Monopar and NorthStar Join Forces to Develop
Radio-Immuno-Therapeutics (RITs) Targeting Severe
COVID-19
Chicago, IL and Beloit, WI, June 16, 2020 - Monopar
Therapeutics Inc. (Nasdaq: MNPR) (Chicago, IL) and NorthStar
Medical Radioisotopes, LLC (Beloit, WI) announced today a 50/50
collaboration to develop potential Radio-Immuno-Therapeutics (RITs)
to treat severe COVID-19 (patients with SARS-CoV-2 infection).
Monopar is a clinical-stage biopharmaceutical company and NorthStar
is a commercial producer and supplier of medical radioisotopes.
This collaboration combines NorthStar’s expertise in the
innovative production, supply, and distribution of important
medical radioisotopes with Monopar’s expertise in therapeutic
drug development and its pre-IND stage humanized urokinase
plasminogen activator receptor (uPAR) targeted monoclonal antibody
known as MNPR-101, along with a proprietary portfolio of related
monoclonal antibodies that target uPAR or its ligand
uPA.
The uPA
system (comprised of the serine protease enzyme uPA and its
receptor uPAR) has been demonstrated to be selectively expressed on
aberrantly activated immune cells. In response to coronavirus
infection, these rogue immune cells produce pro-inflammatory
cytokines that can cause runaway inflammation throughout the body,
commonly referred to as a cytokine storm. It is this systemic
hyper-inflammatory state that is thought to be largely responsible
for the severe lung injury and further multiple organ damage that
contributes to poor outcomes and death in patients with severe
COVID-19.
In this
collaboration, Monopar and NorthStar plan to couple MNPR-101 to a
therapeutic radioisotope supplied by NorthStar in order to create a
highly selective agent that has the potential to kill aberrantly
activated cytokine-producing immune cells. By eradicating these
cells with a targeted RIT, the goal is to spare healthy cells while
quickly reducing the cytokine storm and its harmful systemic
effects.
“This
collaboration is a powerful combination of unique scientific and
technical expertise to help combat severe COVID-19,” said
Chandler Robinson, MD, CEO of Monopar Therapeutics. “The
companies will be conducting a development program to determine if
Monopar’s uPA/uPAR monoclonal antibodies can be transformed
into RITs that are effective as treatments against severe COVID-19,
as well as other corona viruses.”
“We
are pleased to work together with Monopar in the battle against
COVID-19,” said Stephen Merrick, CEO of NorthStar Medical
Radioisotopes.” Our hope is that, by joining forces, we can
develop a targeted radiopharmaceutical treatment that has the
ability to prevent patients with severe COVID-19 from being placed
on ventilators and from dying.”
“To
help mitigate the cytokine storm and reduce deaths associated with
COVID-19, our goal is to develop an RIT that selectively eliminates
the rogue aberrantly activated immune cells that produce these
cytokines,” said Andrew Mazar, PhD, Chief Scientific Officer
of Monopar. “uPAR is selectively expressed on these rogue
immune cells but not on healthy cells. An antibody carrying a
therapeutic radioisotope could gain entry into these cells through
uPAR and deliver its cytotoxic payload to kill these cells while
sparing normal tissue.”
“NorthStar will apply its expertise to identify and supply
the optimal therapeutic radioisotope to couple with Monopar’s
uPAR monoclonal
antibodies,” said James T.
Harvey, PhD, Senior Vice President and Chief Science Officer of
NorthStar. “We will deploy the most appropriate development
approaches and production technology to ensure that both
development and, if successful, commercial-scale volumes of this
radioisotope can be supplied in order to meet potential
demand.”
This
targeted therapeutic approach to treating severe COVID-19 is
supported by a recently published study (Rovina et al. 2020)
demonstrating that soluble urokinase plasminogen activator receptor
(suPAR), which is shed by aberrantly activated immune cells that
make uPAR, is an early predictor of severe respiratory failure in
COVID-19 and its presence increases as patients develop severe
COVID-19.
About Monopar Therapeutics Inc. (Monopar)
Monopar
Therapeutics is a clinical-stage biopharmaceutical company focused
on developing proprietary therapeutics designed to extend life or
improve the quality of life for cancer patients. Monopar's pipeline
consists of Validive® for the prevention of
chemoradiotherapy-induced severe oral mucositis in oropharyngeal
cancer patients; camsirubicin for the treatment of advanced soft
tissue sarcoma; and a late-stage preclinical antibody MNPR-101. For
more information, visit: https://www.monopartx.com.
About NorthStar Medical Radioisotopes, LLC (NorthStar)
NorthStar
Medical Radioisotopes is a global innovator in the production and
distribution of radioisotopes used for medical imaging and
therapeutic purposes. NorthStar is a company committed to providing
the United States with reliable and environmentally friendly
radioisotope supply solutions to meet the needs of patients and to
advance clinical research. The Company’s first product is the
RadioGenix® System (technetium Tc 99m generator), an
innovative and flexible platform technology initially approved by
the U.S. Food and Drug Administration in February 2018. For more
information, visit: https://www.northstarnm.com.
Forward-Looking Statements
Statements
contained in this press release regarding matters that are not
historical facts are "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995.
The words “may,” “will,”
“could,” “would,” “should,”
“expect,” “plan,” “anticipate,”
“intend,” “believe,”
“estimate,” “predict,”
“project,” “potential,”
“continue,” “target” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Examples of these forward-looking statements
include statements concerning the collaboration’s ability to
develop a targeted radiopharmaceutical treatment that has the
ability to prevent patients with severe COVID-19 from being placed
on ventilators and from dying. The forward-looking statements
involve risks and uncertainties including, but not limited to, the
lack of any clinical activities to date with respect to MNPR-101
and that pre-clinical development activities to date have been
focused on the treatment of cancers, the requirement for additional
capital to complete preclinical and clinical development, and if
successful, commercialization, not being able to couple MNPR-101 to
a therapeutic radioisotope, the conjugate not being able to kill
aberrantly activated cytokine-producing immune cells, the conjugate
not being able to use uPAR to gain entry into these cells and
release this cytotoxic payload to kill these cells while sparing
normal tissue, not being able to ensure volumes of this
radioisotope can be manufactured and scaled up to meet potential
demand, uncertainties about levels of demand if and when a
treatment is available for commercialization and the significant
general risks and uncertainties surrounding the research,
development, regulatory approval and commercialization of
therapeutics. Actual results may differ materially from
those expressed or implied by such forward-looking statements.
Risks are described more fully in Monopar's filings with the
Securities and Exchange Commission. All forward-looking statements
contained in this press release speak only as of the date on which
they were made. Monopar and NorthStar undertake no obligation to
update such statements to reflect events that occur or
circumstances that exist after the date on which they were made.
Any forward-looking statements contained in this press release
represent Monopar’s and NorthStar’s views only as of
the date hereof and should not be relied upon as representing its
views as of any subsequent date.
CONTACTS:
For Monopar Therapeutics Inc.:
Investor
Relations:
Kim R.
Tsuchimoto
Chief
Financial Officer
kimtsu@monopartx.com
For NorthStar Medical Radioisotopes, LLC
Investor
Relations:
Paul
Estrem
Senior
Vice President and Chief Financial Officer
pestrem@northstarnm.com
Corporate:
Lisa Holst
Vice President Sales and Marketing
678-471-9027
lholst@northstarnm.com
Media:
Priscilla Harlan
781-799-7917
pharlan@shiningrockllc.com