Monopar Receives Clearance to Proceed with First-in-Human Phase 1 Trial of Novel Radiopharmaceutical MNPR-101-Zr in Advanced Cancers
20 Februar 2024 - 2:00PM
Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage
biopharmaceutical company focused on developing innovative
treatments for cancer patients, today announced it has received
Human Research Ethics Committee (HREC) clearance in Australia to
commence a Phase 1 dosimetry trial of its novel radiopharmaceutical
MNPR-101-Zr.
The MNPR-101-Zr Phase 1 dosimetry clinical trial will enroll
patients with advanced cancers and will utilize positron emission
tomography (PET) imaging to assess tumor uptake, normal organ
biodistribution, and safety.
MNPR-101-Zr is a zirconium-89 (imaging radioisotope) labeled
version of MNPR-101, Monopar’s proprietary first-in-class humanized
monoclonal antibody that is highly selective against the urokinase
plasminogen activator receptor (uPAR). PET imaging studies in
preclinical xenograft models of triple-negative breast, colorectal,
and pancreatic cancers displayed high and selective uptake of
MNPR-101-Zr in these uPAR-expressing tumors. The imaging results,
along with corresponding in vivo efficacy studies with actinium-225
(Ac-225, a powerful alpha-emitting therapeutic radioisotope) bound
to MNPR-101 in preclinical xenograft tumor models, support the
development MNPR-101 as a targeted radiopharmaceutical for multiple
advanced cancer indications.
“This is a significant milestone for Monopar,” said Chandler
Robinson, MD, Monopar’s Chief Executive Officer. “Following more
than 18 months of extensive preclinical development, we believe we
are well-positioned in this space. This is our first human clinical
trial using our uPAR targeting agent. There has been quite
impressive clinical data generated in the radiopharma sector of
late, such as against PSMA and SSTR2 expressing cancers, and we
believe this to be just the beginning.”
If the tumor uptake, biodistribution, and safety look
encouraging in this Phase 1 clinical trial, which is anticipated to
enroll around 12 patients and to initiate in the near future, the
plan is to evaluate the efficacy in humans of a therapeutically
radio-labeled version of MNPR-101 bound to an isotope such as
Ac-225.
About Monopar Therapeutics Inc. Monopar Therapeutics
is a clinical-stage biopharmaceutical company primarily 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 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 MNPR-101-Zr Phase 1 dosimetry clinical trial will enroll
patients with advanced cancers and will utilize positron emission
tomography (PET) imaging to assess tumor uptake, normal organ
biodistribution, and safety; that the Phase 1 clinical trial is
anticipated to enroll around 12 patients in the near future; and
that the plan is to evaluate the efficacy in humans of a
therapeutically radio-labeled version of MNPR-101 bound to an
isotope such as Ac-225. The forward-looking statements involve
risks and uncertainties including, but not limited to: not
initiating and enrolling the Phase 1 clinical trial in 2024, if at
all; that MNPR-101-Zr may cause unexpected serious adverse effects
or fails to image 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
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