Monopar Announces First Patient Enrolled in First-in-Human Phase 1 Trial for Its Novel Radiopharmaceutical MNPR-101-Zr
July 09 2024 - 6:00AM
Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage
radiopharma company focused on developing innovative treatments for
cancer patients, today announced the enrollment of the first
patient in its first-in-human Phase 1 dosimetry and imaging
clinical trial of MNPR-101-Zr. This novel radiopharmaceutical
imaging agent combines MNPR-101, Monopar’s antibody that
selectively targets the urokinase plasminogen activator receptor
(uPAR), with the radioisotope zirconium-89.
Monopar’s Phase 1 clinical trial, led by internationally
recognized nuclear medicine physician Professor Rodney Hicks at the
Melbourne Theranostic Innovation Centre, aims to assess the safety
and dosimetry of MNPR-101-Zr in up to 12 patients with advanced
cancers. This is the first human study to evaluate a radiolabeled
monoclonal antibody targeting uPAR.
“uPAR is a well-credentialed cancer target found in some of the
most aggressive, deadly cancers, including pancreatic, triple
negative breast, and colorectal cancers. We are very much looking
forward to seeing the biodistribution and dosimetry data from this
study,” said Chandler Robinson, MD, Monopar’s Chief Executive
Officer.
“We are pleased to enroll our inaugural patient. Encouraging
preclinical results in several challenging cancers underscore the
potential of uPAR as a promising target to battle some of the most
lethal cancers,” added Andrew Cittadine, Monopar’s Chief Operating
Officer.
Further information about this clinical trial is available at
www.ClinicalTrials.gov under study identifier
NCT06337084.
About Monopar Therapeutics Inc.
Monopar Therapeutics is a clinical-stage radiopharmaceutical
company focused on developing innovative treatments for cancer
patients, including Phase 1-stage MNPR-101-Zr for imaging advanced
cancers and late preclinical-stage MNPR-101
radio-immuno-therapeutic (RIT) for the treatment of advanced
cancers, as well as early development programs against solid
cancers. 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 statements concerning: The Company’s Phase 1 trial aims to
assess the safety and dosimetry of MNPR-101-Zr in up to 12 patients
with advanced cancers; Monopar is very much looking forward to
seeing the biodistribution and dosimetry data from this Phase-1
trial; and that encouraging preclinical results in several
challenging cancers underscore the potential of uPAR as a promising
target to battle some of the most lethal cancers. The
forward-looking statements involve risks and uncertainties
including, but not limited to: the enrolled patient may not receive
the scheduled dose of MNPR-101-Zr; the Phase 1 imaging and
dosimetry clinical trial in advanced cancer patients with
MNPR-101-Zr may not yield satisfactory results, if at all; that
future preclinical or clinical data will not be as promising as the
data to date; that MNPR-101-Zr may cause unexpected serious adverse
effects in humans; that Monopar may expend available funds sooner
than anticipated or require additional funding due to change in
circumstances or unanticipated events; 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 Karthik
Radhakrishnan Chief Financial Officer karthik@monopartx.com
Follow Monopar on social media for updates:Twitter: @MonoparTx
LinkedIn: Monopar Therapeutics
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