Monopar
and NorthStar Collaborating with Texas Lung Injury Institute for
Testing of Novel Potential Therapeutic for Severe
COVID-19
WILMETTE, IL, BELOIT, WI, and TYLER, TX, SEPTEMBER 9, 2020
– Monopar Therapeutics Inc. (Nasdaq: MNPR) and NorthStar
Medical Radioisotopes, LLC, which are jointly developing
urokinase plasminogen activator receptor targeted
radio-immuno-therapeutics (uPRITs) for the potential
treatment of patients with severe COVID-19, today announced a
collaboration with The University of
Texas Health Science Center at Tyler (UTHSCT) and its Texas Lung
Injury Institute (TLII). UTHSCT is planning to perform
in vitro
and in vivo studies through the TLII and participate in the
clinical development of uPRITs for the treatment of severe COVID-19
through its medical center.
The University of Texas Health Science Center at Tyler has taken a
leading role in the fight against COVID-19. UTHSCT was recently
awarded a $2 million National Institutes of Health (NIH) grant to
investigate the potential use of convalescent plasma
from recovered COVID-19
patients to prevent worsening
lung symptoms, or death, in hospitalized COVID-19 patients.
Enrollment for this study has already started. UTHSCT is also home
to one of the leading laboratories in the world studying the role
of urokinase plasminogen activator receptor (uPAR) in acute lung
injury and respiratory distress, led by renowned pulmonologist
Steven Idell, MD, PhD.
“Given their expertise in uPAR, acute lung injury, as well as
the treatment of COVID-19 patients, UTHSCT and Dr. Steven Idell are
the ideal partners for the preclinical and clinical development of
uPRITs for severe COVID-19,” said Andrew Mazar, PhD, chief
scientific officer of Monopar.
“Dr. Idell and UTHSCT have extensive experience with
cell-based and animal models of respiratory distress, along with
COVID-19 clinical trials. These resources and experiences should
help accelerate the development of uPRITs,” said James T.
Harvey, PhD, senior vice president and chief science officer of
NorthStar.
“We are excited to be working with Monopar and NorthStar on
developing a uPRIT, an innovative and clinically promising
treatment for severe COVID-19 patients,” said Dr. Steven
Idell, senior vice president for research and dean of the School of
Medical Biological Sciences at UTHSCT.
The aim of this partnership is to evaluate uPRIT candidates
in in
vitro and in vivo models to facilitate the selection and
IND-enabling development of a clinical candidate that could then
move into first-in-human trials in patients with severe COVID-19 at
UTHSCT.
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.
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.
About The University of Texas Health Science Center at
Tyler
As part
of the world-renowned University of Texas System, The University of
Texas Health Science Center at Tyler (UTHSCT) is a graduate school
providing programs for those seeking careers in the medical field.
UTHSCT offers Master of Science in Biotechnology, Master of Public
Health and Master of Health Administration degrees, as well as
residency programs for medical school graduates in family medicine, general surgery, internal
medicine, occupational medicine, rural family medicine, general
psychiatry and rural psychiatry. Psychology internships and
fellowships are also available. Graduate students, medical residents and
other medical professionals-in-training develop marketable skills
and qualifications to excel in the medical field as they learn
alongside innovative scientists, physicians and other healthcare
experts at UTHSCT and UT Health East Texas, a 10-hospital health
system throughout East Texas. Led by Kirk A. Calhoun, MD, FACP, the
university will soon become the home to the first medical school in
East Texas, pending regulatory and accreditation approval.
For more information, visit
www.uthct.edu.
About the TLII
Housed within UTHSCT, the Texas Lung Injury Institute (TLII) was
created in 2004 to provide state-of-the-art research that advances
our understanding about the pathogenesis of lung disease and its
treatment. For more information, visit: https://www.uthct.edu/texas-lung-injury-institute.
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 Monopar’s and NorthStar’s
ability to develop uPRITs for the potential treatment of patients
with severe COVID-19; UTHSCT’s
ability to perform in vitro and in vivo studies through the TLII and participate in the
clinical development of uPRITs for the treatment of severe COVID-19
through its medical center; UTHSCT’s ability to accelerate
the development of uPRITs; uPRITs ability to be an innovative and
clinically promising treatment for severe COVID-19 patients; and
that uPRIT candidates in in vitro and in vivo models can facilitate the selection and
IND-enabling development of a clinical candidate that could then
move into first-in-human trials in patients with severe COVID-19 at
UTHSCT. 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, potential for 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, NorthStar and TLII 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, NorthStar’s and TLII’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
For The University of Texas Health Science Center at
Tyler
Media
Contact:
Janet
Ragland
Senior
Media Specialist
janet.ragland@uthct.edu
(903)
241-5109