uPAR

WILMETTE, Ill., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharmaceutical company focused on developing innovative treatments for cancer patients, is presenting today data from the clinical and preclinical development of its novel first-in-class lead radiopharma program based on MNPR-101 at the European Association of Nuclear Medicine (EANM) 2024 Annual Congress held in Hamburg, Germany. MNPR-101-Lu radiation dosimetry analytics using human data from MNPR-101-Zr show a favorable organ safety profile at high Lu-177 therapeutic dose levels. The slides for Monopar’s oral presentation can be found at the following link: https://www.monopartx.com/pipeline/mnpr-101/eanm24-ppt. Monopar’s presentation, accepted as a “Top-Rated Oral Presentation” within the Scientific Program, illustrates the potential of the urokinase plasminogen activator receptor (uPAR) as a promising radiopharma target in solid tumors. Preclinical and clinical data show favorable biodistribution, tumor uptake, and low off-target binding of Monopar’s uPAR-targeted radiopharmaceuticals MNPR-101-Zr and MNPR-101-Lu. “We were able to optimize our uPAR-targeted radiopharmaceuticals in preclinical studies, and the data show these efforts have translated directly into humans with encouraging tumor uptake. Even at the highest Lu-177 therapeutic antibody dose we are aware of in the clinic, we estimate a favorable radiation dosimetry safety profile for off-target effects such as bone marrow exposure,” said Andrew Cittadine, Monopar’s Chief Operating Officer. Further information about the MNPR-101-Lu Phase 1a trial is available at www.ClinicalTrials.gov under study identifier NCT06617169. Further information about the MNPR-101-Zr Phase 1 imaging and dosimetry 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, Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced cancers, as well as early development-stage radiopharma 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: MNPR-101-Lu radiation dosimetry analytics using human data from MNPR-101-Zr show a favorable organ safety profile at high Lu-177 therapeutic dose levels; Monopar’s presentation illustrates the potential of the urokinase plasminogen activator receptor (uPAR) as a promising radiopharma target in solid tumors; preclinical and clinical data show favorable biodistribution, tumor uptake, and low off-target binding of Monopar’s uPAR-targeted radiopharmaceuticals MNPR-101-Zr and MNPR-101-Lu; optimization of uPAR-targeted radiopharmaceuticals in preclinical studies show translation in humans with encouraging tumor uptake; and even the highest Lu-177 therapeutic antibody dose in the clinic presents a favorable radiation dosimetry safety profile for off-target effects such as bone marrow exposure. The forward-looking statements involve risks and uncertainties including, but not limited to: that radiation dosimetry analytics in the future may not be consistent with the estimated data generated thus far; Monopar may not find patients to enroll its MNPR-101-Lu therapeutic study; that the Phase 1 imaging and dosimetry clinical trial in advanced cancer patients with MNPR-101-Zr may not yield consistently satisfactory results; that future preclinical or clinical data may not be as promising as the data to date; that MNPR-101-Zr and/or MNPR-101-Lu may cause unexpected serious adverse effects or fail to be effective against the cancer tumors in humans; that the trials could result in a clinical hold should there be a Serious Adverse Event; 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 RadhakrishnanChief Financial Officer karthik@monopartx.com Follow Monopar on social media for updates:Twitter: @MonoparTx  LinkedIn: Monopar Therapeutics

WILMETTE, Ill., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, today announced the filing of a provisional patent covering new therapeutic radiopharmaceuticals based on a family of linkers used to connect radioisotopes with targeting agents, including Monopar’s uPAR targeting antibody MNPR-101. Highlights of the patent filing include: Composition of Matter: Claims cover a family of linkers, as well as Monopar’s uPAR targeting agents linked with these along with therapeutic radioisotopesStability and Biodistribution: These proprietary new linkers have been created to enhance the stability and biodistribution of Monopar’s array of therapeutic radiopharmaceuticalsVersatility: The newly developed linker family works with a wide range of isotopes and targeting molecules, including small molecules/peptides and antibodies “This provisional patent could enable us to use these linkers to create new proprietary radiopharmaceuticals going after well-established, high-value cancer targets that we are interested in,” commented Andrew Cittadine, Monopar’s Chief Operating Officer. “We also believe that these linkers may be of great interest to others in the industry, opening the door to potential licensing and development collaborations.” “These novel linkers and compositions of matter exemplify Monopar’s passion and commitment to being an innovator in the radiopharma space,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer. 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, Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced cancers, as well as early development stage 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: that these proprietary new linkers have been created to enhance the stability and biodistribution of Monopar’s array of therapeutic radiopharmaceuticals; that this newly developed linker family works with a wide range of isotopes and targeting molecules, including small molecules/peptides and antibodies; and that this provisional patent could enable Monopar to use these linkers to create new proprietary radiopharmaceuticals going after well-established, high-value cancer targets of interest to Monopar or others in the industry opening the door to potential licensing and development collaborations. The forward-looking statements involve risks and uncertainties including, but not limited to: that the new linker family may not be as stable in humans as anticipated; that patent applications may not result in allowed patents; that if allowed, the patents may be too narrow in scope to provide protection needed to successfully develop the radiopharma program; that we may expend available funds sooner than anticipated or require additional funding due to change in circumstances or unanticipated events; that future preclinical or clinical data will not be as promising as the data to date; not successfully enrolling the MNPR-101-Zr Phase 1 and/or the MNPR-101-Lu clinical trials; 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; 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

WILMETTE, IL, USA I October 07, 2024 I Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, today announced that the Phase 1a clinical trial for its novel therapeutic radiopharmaceutical MNPR-101-Lu (MNPR-101 conjugated to lutetium-177) is now active and recruiting patients with advanced cancers. The Phase 1a trial is an open-label dose-escalation study of MNPR-101-Lu in patients with solid tumors. The first clinical trial site activated for the study is the Melbourne Theranostic Innovation Centre (MTIC) in Australia. To help identify those patients most likely to benefit from MNPR-101-Lu, the trial will only be open to those participating in the ongoing MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial. MNPR-101 is Monopar’s proprietary antibody that targets the urokinase plasminogen activator receptor (uPAR), which is expressed in numerous tumor types including pancreatic, breast, colorectal, ovarian, and bladder. By selectively targeting uPAR, Monopar aims to deliver a radiopharma therapy that kills cancer cells while minimizing damage to healthy tissue. Both clinical ( link ) and preclinical ( link ) data to date have demonstrated highly specific and durable tumor uptake of MNPR-101-Zr (MNPR-101 conjugated to zirconium-89). “We are very encouraged by the recently released human clinical data and preclinical efficacy results ( link ), and are thrilled to be launching this therapeutic trial months ahead of our originally planned schedule,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer. “We believe this may be the world’s first uPAR-targeted therapeutic radiopharma clinical trial,” commented Andrew Cittadine, Monopar’s Chief Operating Officer. “Our goal is to light up the tumors with MNPR-101-Zr and then treat them with MNPR-101-Lu.” Further information about the MNPR-101-Lu trial is available at www.ClinicalTrials.gov under study identifier NCT06617169. Details about the ongoing MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial are 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, Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced cancers, as well as early development-stage radiopharma programs against solid cancers. For more information, visit: www.monopartx.com. SOURCE: Monopar Therapeutics