Monopar Announces Promising Preclinical Data for its MNPR-101 Radiopharma Program Targeting Advanced Cancers
February 22 2024 - 7:00AM
Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage
biopharmaceutical company focused on developing innovative
treatments for cancer patients, today announced promising
preclinical imaging and therapeutic efficacy data for its MNPR-101
radiopharmaceutical program. This novel first-in-class radiopharma
program targets cancers expressing the urokinase plasminogen
activator receptor (uPAR), which include a majority of all
triple-negative breast, colorectal, and pancreatic cancers.
MNPR-101 Conjugated to Imaging Radioisotope
Maximizing the dose delivered to the tumor relative to normal
tissue is of paramount importance in radiopharmaceutical therapy.
Figure 1 below shows the before and after optimization of
MNPR-101-Zr, Monopar’s radiopharmaceutical imaging agent for
advanced solid tumors expressing uPAR. Monopar’s in-house
radiopharmaceutical development team was able to significantly
increase tumor uptake of MNPR-101-Zr while minimizing uptake in
healthy tissue, as shown in this preclinical positron emission
tomography (PET) sequential imaging time-series. The high
specificity and durable tumor uptake are evident in the After
Optimization panel below.
MNPR-101 Conjugated to Therapeutic
Radioisotopes
Preclinical data to date demonstrate compelling and durable
anti-tumor benefits with MNPR-101 conjugated to therapeutic
radioisotopes. Figure 2 below shows preclinical efficacy data in a
triple negative breast cancer as well as a pancreatic cancer human
tumor xenograft mouse model utilizing two different therapeutic
radioisotopes conjugated to MNPR-101; one of these radioisotopes
has already been disclosed as being actinium-225 (Ac-225). The
results in both show near complete elimination of the tumor after a
single injection of the radiopharmaceutical agent. These studies
demonstrate the potential of a MNPR-101 based radiopharmaceutical
to provide a very meaningful clinical benefit to patients.
Monopar recently announced it received Human
Research Ethics Committee (HREC) clearance in Australia to commence
a Phase 1 dosimetry clinical trial for MNPR-101-Zr in advanced
cancer patients. “As we prepare to launch this clinical trial, we
are encouraged by the significant, precise, and durable
accumulation we are seeing in tumors and the corresponding
therapeutic benefit in preclinical human tumor xenograft models,”
said Andrew Cittadine, Monopar’s Chief Operating Officer. “We are
aiming to present these promising preclinical results at an
upcoming scientific meeting.”
About Monopar Therapeutics Inc.
Monopar Therapeutics is a clinical-stage biopharmaceutical
company focused on developing innovative treatments for cancer
patients. Monopar's pipeline consists of Phase 1b-stage
camsirubicin for the treatment of advanced soft tissue sarcoma;
Phase 1-stage MNPR-101 for radiopharmaceutical use in advance
cancers; and an early-stage camsirubicin analog, MNPR-202. For more
information, visit: www.monopartx.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: that these studies demonstrate the potential of
an MNPR-101 based radiopharmaceutical to provide a very meaningful
clinical benefit to patients; and that we are aiming to present
these promising preclinical results at an upcoming scientific
meeting. The forward-looking statements involve risks and
uncertainties including, but not limited to: that future
preclinical or clinical data will not be as promising as the data
to date; not initiating and enrolling the Phase 1 clinical trial;
that MNPR-101-Zr may cause unexpected serious adverse effects or
fail to image or be effective against the cancer tumors in humans;
the potential for the HREC to put the Phase 1 trial on clinical
hold at any time; and the significant general risks and
uncertainties surrounding the research, development, regulatory
approval, and commercialization of imaging agents and 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 undertakes 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 views only as of the date hereof and should not be
relied upon as representing its views as of any subsequent
date.
CONTACT:
Monopar Therapeutics Inc.Investor RelationsKim
R. TsuchimotoChief Financial Officerkimtsu@monopartx.com
Follow Monopar on social media for updates:
Twitter: @MonoparTx LinkedIn: Monopar Therapeutics
Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/3a5deb93-2122-4ee4-9ecb-745d9cbf923b
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