Monopar Presents Encouraging Human Clinical Dosimetry Data on its uPAR Program at EANM 2024

Rhea-AI Summary

Monopar Therapeutics Inc. (Nasdaq: MNPR) is presenting encouraging data from its uPAR radiopharmaceutical program at the EANM 2024 Annual Congress. The presentation, recognized as a "Top-Rated Oral Presentation," showcases favorable human clinical dosimetry data for MNPR-101-Lu, derived from MNPR-101-Zr imaging studies.

Key highlights include:

• Favorable organ safety profile at high Lu-177 therapeutic dose levels
• Promising uPAR targeting in solid tumors
• Encouraging tumor uptake and low off-target binding
• Estimated favorable radiation dosimetry safety profile for off-target effects

The company's Phase 1a trial for MNPR-101-Lu (NCT06617169) and Phase 1 imaging and dosimetry trial for MNPR-101-Zr (NCT06337084) are ongoing.

Positive

• Presentation recognized as a "Top-Rated Oral Presentation" at EANM 2024
• Favorable organ safety profile observed at high Lu-177 therapeutic dose levels
• Encouraging tumor uptake and low off-target binding in human clinical data
• Estimated favorable radiation dosimetry safety profile for off-target effects

Negative

• None.

Insights

Medical Research Analyst

The presentation of encouraging human clinical dosimetry data for Monopar's uPAR-targeted radiopharmaceutical program at EANM 2024 is a significant development. Key points include:

• MNPR-101-Lu shows a favorable organ safety profile at high Lu-177 therapeutic dose levels, based on human data from MNPR-101-Zr.
• Preclinical and clinical data demonstrate favorable biodistribution, tumor uptake and low off-target binding for both MNPR-101-Zr and MNPR-101-Lu.
• The company claims to have achieved the highest Lu-177 therapeutic antibody dose known in the clinic, while maintaining a favorable radiation dosimetry safety profile.

This data suggests potential for improved efficacy and safety in treating solid tumors. However, it's important to note that these are early-stage results and further clinical trials are needed to confirm therapeutic efficacy and long-term safety. The ongoing Phase 1a trial for MNPR-101-Lu (NCT06617169) will be important in determining its clinical potential.

Financial Analyst

While the clinical data is promising, investors should consider several financial aspects:

• Monopar's market cap of $18.48 million suggests it's a small-cap biotech company, which typically carries higher risk.
• The company's focus on radiopharmaceuticals positions it in a growing market segment, with potential for significant returns if successful.
• However, the path to commercialization is long and expensive. Monopar will likely need additional funding to complete clinical trials and potential commercialization.
• The positive reception at EANM 2024 ("Top-Rated Oral Presentation") may increase visibility and potentially attract partnerships or investment.

Investors should monitor cash burn rate, upcoming milestones in the Phase 1a trial and any partnership announcements. While the news is positive, it's early-stage and the company's financial position will be critical in determining long-term success.

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 Radhakrishnan
Chief Financial Officer 
karthik@monopartx.com

Follow Monopar on social media for updates:
Twitter: @MonoparTx  LinkedIn: Monopar Therapeutics

FAQ

What is Monopar Therapeutics (MNPR) presenting at EANM 2024?

Monopar Therapeutics is presenting encouraging human clinical dosimetry data on its uPAR radiopharmaceutical program, specifically for MNPR-101-Lu, at the European Association of Nuclear Medicine (EANM) 2024 Annual Congress in Hamburg, Germany.

What are the key findings from Monopar's (MNPR) uPAR radiopharmaceutical program?

The key findings include a favorable organ safety profile at high Lu-177 therapeutic dose levels, promising uPAR targeting in solid tumors, encouraging tumor uptake, low off-target binding, and an estimated favorable radiation dosimetry safety profile for off-target effects such as bone marrow exposure.

What clinical trials are currently ongoing for Monopar's (MNPR) uPAR radiopharmaceuticals?

Monopar has two ongoing clinical trials: a Phase 1a trial for MNPR-101-Lu (NCT06617169) and a Phase 1 imaging and dosimetry trial for MNPR-101-Zr (NCT06337084).

How was Monopar's (MNPR) presentation received at EANM 2024?

Monopar's presentation was accepted as a "Top-Rated Oral Presentation" within the Scientific Program at the EANM 2024 Annual Congress, indicating a high level of recognition for their research.