Monopar Announces Positive Preclinical Therapeutic Isotope Data for its MNPR-101 Radiopharma Program
March 05 2024 - 7:00AM
Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage
biopharmaceutical company focused on developing innovative
treatments for cancer patients, today announced positive
preclinical imaging data of a therapeutic radioisotope bound to its
proprietary uPAR (urokinase plasminogen activator receptor)
targeting agent MNPR-101. The data clearly demonstrate highly
preferential uptake in the tumor. This is an extension of the tumor
imaging and efficacy data Monopar released on February 22 (link),
where Monopar disclosed biodistribution data with a diagnostic
imaging radioisotope (Zirconium-89) as well as efficacy data with
therapeutic radioisotopes (e.g., Actinium-225) bound to MNPR-101 in
human tumor xenograft models. The new imaging data released today
provide additional support for the tumor-targeting ability of
MNPR-101 and help explain the near complete elimination of tumors
(link) observed after a single injection of therapeutic
radioisotopes bound to MNPR-101.
Biodistribution of a Therapeutic
Radioisotope Conjugated to MNPR-101Two of the most
commercially successful radiopharmaceuticals, Pluvicto® and
Lutathera™, use the therapeutic radioisotope Lutetium-177 (Lu-177).
Beyond killing cancer cells, this radioisotope has the added
advantage that its biodistribution can be visualized via SPECT
(single-photon emission computed tomography) imaging. Monopar
collected a sequential SPECT imaging time-series utilizing MNPR-101
conjugated to Lu-177 (MNPR-101-Lu) in a uPAR-expressing human
pancreatic cancer xenograft model. The results can be seen in
Figure 1. High specificity and durable uptake of MNPR-101-Lu in the
tumor relative to normal tissue is readily apparent, and these
results are consistent with the previously released data for
Monopar’s diagnostic imaging radiopharmaceutical MNPR-101-Zr.
“Delivering a high dose to the tumor relative to normal tissue
is of central importance in radiopharmaceutical therapy,” said
Andrew Cittadine, Monopar’s Chief Operating Officer. “These data
help explain the compelling and durable anti-tumor benefits
observed to-date in preclinical studies using MNPR-101 conjugated
to therapeutic radioisotopes.”
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 (link). The data disclosed today further support Monopar’s
efforts to create a radiodiagnostic and radiotherapeutic pairing to
image and treat uPAR-positive cancers.
“Some of the most aggressive, deadly cancers express uPAR, such
as triple negative breast cancer and pancreatic cancer,” said
Chandler Robinson, MD, Monopar’s Chief Executive Officer. “These
data further support the potential of a MNPR-101 based
radiopharmaceutical to provide a very meaningful clinical benefit
to patients with uPAR-positive tumors.”
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 various
advanced 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 data disclosed today further support
Monopar’s efforts to create a radiodiagnostic and radiotherapeutic
pairing to image and treat uPAR-positive cancers; and that these
data further support the potential of a MNPR-101 based
radiopharmaceutical to provide a very meaningful clinical benefit
to patients with uPAR-positive tumors. 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 and/or MNPR-101-Lu 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
Relations Kim R. Tsuchimoto Chief Financial
Officer kimtsu@monopartx.com
Follow Monopar on social media for updates:
Twitter: @MonoparTx LinkedIn: Monopar Therapeutics
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/0773bb83-f9ca-4ee3-b947-37260033b8a9
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