MONOPAR AND NORTHSTAR ANNOUNCE SELECTION OF uPRIT CANDIDATE FOR
POTENTIAL TREATMENT OF SEVERE COVID-19
Wilmette, IL, and Beloit, WI, December 10, 2020–
Monopar Therapeutics Inc. (Nasdaq: MNPR) and NorthStar Medical
Radioisotopes, LLC, which are jointly developing a urokinase
plasminogen activator receptor targeted radio-immuno-therapeutic
(uPRIT) for the potential treatment of severe COVID-19, today
announced the selection of a uPRIT clinical candidate. Monopar and
NorthStar partnered with IsoTherapeutics Group LLC to generate a
panel of uPRIT leads, which were then screened by Aragen Bioscience
Inc., resulting in the identification of a uPRIT clinical candidate
plus several backup candidates.
uPRITS
are analogs of MNPR-101, Monopar’s proprietary humanized
urokinase plasminogen activator receptor (uPAR) targeted antibody,
that have been modified to enable attachment of a therapeutic
radioisotope. uPRITs bind to uPAR with high affinity and are
thought to selectively recognize the aberrantly activated,
pro-inflammatory immune cells that express this target and also
seem to be mediating the cytokine storm leading to respiratory
failure and poor outcomes in severe COVID-19 patients.
The
cleaved, blood-circulating soluble form of uPAR, suPAR, has been
gaining attention as a potentially important prognostic biomarker
for severe COVID-19 in several recently published studies. Rovina
et al. 2020 showed that patients with elevated levels of suPAR at
the time of hospital admission are 17 times more likely to develop
severe respiratory failure (p=0.0000000012); Arnold et al. 2020
showed suPAR to have the best performance in predicting outcome
(such as intensive care unit admission and death) of all the
biomarkers examined; and Eugen-Olsen et al. 2020 showed that low
levels of suPAR are predictive of mild outcome in COVID-19
patients.
The aim
with uPRITs is to bind to and rapidly eliminate the aberrantly
activated immune cells, quickly shutting down the cytokine storm.
If uPRITs are effective in this setting, they may also be effective
in treating other diseases characterized by rapid and severe
systemic inflammatory responses, including certain pneumonias and
sepsis.
The
uPRIT with the most attractive uPAR binding profile was selected to
advance into IND-enabling studies. “Selection of a uPRIT
candidate allows us to begin preclinical studies, and brings us one
step closer to reaching human clinical trials,” said Andrew
Mazar, Ph.D., Chief Scientific Officer of Monopar. “Even when
SARS-CoV2 vaccines are available, treatments will be needed for
those who are not vaccinated, or for patients for whom the vaccine
is not effective, and who thereby contract severe COVID-19.
Successfully combatting COVID-19 over the long term will require a
combination of preventive and treatment
approaches.”
“This
rapid advancement of our uPRIT program highlights the innovation
and collaborative efforts of Monopar, NorthStar and our
partners,” stated James Harvey, Ph.D., Senior Vice President
and Chief Scientific Officer of NorthStar. “Selecting a
highly specific therapeutic candidate for the potential treatment
of severe COVID-19 in short order is a significant
achievement.”
About Monopar Therapeutics Inc.
Monopar
Therapeutics is a clinical-stage biopharmaceutical company
primarily 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 advanced cancers and severe COVID-19. For
more information, visit: www.monopartx.com.
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About NorthStar Medical Radioisotopes, LLC
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: 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 selected MNPR-101 derived
uPRIT’s ability to mediate the cytokine storm which leads to
respiratory failure and poor outcomes in severe COVID-19 patients;
whether biomarkers in published studies can be repeated in uPRIT
preclinical and clinical studies; uPRIT’s ability to be
effective in treating other diseases characterized by rapid and
severe systemic inflammatory responses, including certain
pneumonias and sepsis; and whether uPRITs will be successful in
preclinical studies or move forward into clinical trials in
patients with severe COVID-19. 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,
the requirement for additional capital to complete preclinical and
clinical development and for potential commercialization, the uPRIT
not being able to kill aberrantly activated cytokine producing
immune cells, the uPRIT 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 when
vaccines are widely utilized or treatments are approved for
marketing and 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