Monopar Initiates Radiopharma Phase 1 Clinical Trial for MNPR-101-Zr in Advanced Cancer Patients
April 10 2024 - 8:00AM
Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage
biopharmaceutical company focused on developing innovative
treatments for cancer patients, today announced that its Phase 1
dosimetry clinical trial for its novel radiopharmaceutical imaging
agent MNPR-101-Zr (MNPR-101 conjugated to zirconium-89) is now
active and recruiting patients with advanced cancers. The antibody
MNPR-101 targets the urokinase plasminogen activator receptor
(uPAR), which is expressed on numerous tumor types including
pancreatic, breast, colorectal, and bladder.
The study is now open for enrollment at the Melbourne
Theranostic Innovation Centre (MTIC) in Australia, and is being led
by Professor Rodney Hicks, an internationally recognized physician
and pioneer in the radiopharma space. MTIC will use one of the
world's most sensitive, state-of-the-art, clinical total-body
PET/CT (positron emission tomography–computed tomography) scanners,
the Siemens Biograph Vision Quadra, to image the tumor targeting
ability of MNPR-101-Zr in advanced cancer patients.
The Phase 1 dosimetry trial is evaluating the safety and
dosimetry of MNPR-101-Zr in up to 12 patients with advanced cancer.
Preclinical data to date have shown highly specific and durable
tumor uptake of MNPR-101-Zr in human cancer xenograft models.
Moreover, Monopar recently shared positive preclinical efficacy
data showing potent and durable anti-tumor activity of MNPR-101
bound to therapeutic radioisotopes. If the tumor uptake,
biodistribution, and safety look encouraging in this Phase 1
clinical trial for MNPR-101-Zr, the Company plans to expand the
study or initiate a new study to test the potential efficacy of
MNPR-101 bound to a therapeutic radioisotope such as Ac-225 in
patients with advanced cancers.
“The Monopar team is quite excited about this trial initiation,”
said Chandler Robinson, MD, Monopar’s Chief Executive Officer. “The
preclinical results to date in hard-to-treat cancers such as
pancreatic and triple negative breast have impressed us, with our
radiopharma program demonstrating a promising ability to
selectively target and destroy uPAR expressing tumors. We are very
much looking forward to seeing the biodistribution and dosimetry
data from this first-in-human study in advanced cancer
patients.”
Further information about the MNPR-101-Zr trial is available at
www.ClinicalTrials.gov under study identifier
NCT06337084.
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 1-stage MNPR-101 for
radiopharmaceutical use in various advanced cancers; Phase 1b-stage
camsirubicin for the treatment of advanced soft tissue sarcoma; and
an early-stage camsirubicin analog, MNPR-202. For more information,
visit: www.monopartx.com and ir.monopartx.com/presentations.
Forward-Looking StatementsStatements 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 the MTIC
will use one of the world's most sensitive, state-of-the-art,
clinical total-body PET/CT (positron emission tomography–computed
tomography) scanners, the Siemens Biograph Vision Quadra, to image
the tumor targeting ability of MNPR-101-Zr in advanced cancer
patients; that if the tumor uptake, biodistribution, and safety
look encouraging in this Phase 1, the Company plans to test the
efficacy of MNPR-101 bound to a therapeutic radioisotope such as
Ac-225 in patients with advanced cancers; and that Monopar is very
much looking forward to seeing the biodistribution and dosimetry
data from this first-in-human study in advanced cancer patients.
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 enrolling
the Phase 1 clinical trial; that MNPR-101-Zr, MNPR-101-Ac225 and/or
other radiopharmaceuticals we may develop 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
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